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We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and BioPharma – connecting key stakeholders in the drug development ecosystem. We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection. With a global footprint spanning 134 countries, to date we’ve supported over 17,000 patients, 3,000 physicians and 350 sites, earning the trust of 60+ BioPharma companies. In October 2025, we closed a €25M investment with Avego Healthcare Capital to fuel our global ambitions and scale the business. Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today. The opportunity: Regulatory Affairs & Pharmacovigilance Manager As the Regulatory Affairs and Pharmacovigilance Manager, you will be responsible for ensuring compliance of our processes with country-specific expanded access regulations globally. In this role, you'll be a key contributor to our regulatory and quality infrastructure, keeping us aligned with global legislation. You will be actively working together with Medical Affairs, Program Management, Quality Assurance, and Supply Chain and will report to the Director of Regulatory Affairs and Pharmacovigilance (Emily says hi). What you will do in this role: - Support the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs. - Act as the Regulatory Affairs and Pharmacovigilance expert for communications with clients (pharmaceutical companies) and submissions to Health Authorities, as well as cross-functional meetings and audits. - Prepare, compile, and submit regulatory dossiers for cohort and named patient Expanded Access Programs (EAPs) on behalf of clients. - Provide input and support for the regulatory strategy for setting up and executing EAPs (e.g., where, when, and how). - Collaborate with the Commercial team to support new EAPs. - Ensure timely and compliant handling of all regulatory and pharmacovigilance activities related to EAPs. - Stay up to date on relevant global laws, regulations, and guidelines impacting EAPs. - Assist in drafting, reviewing, and maintaining regulatory documentation and templates. - Liaise with the Pharmacovigilance service provider to ensure alignment and compliance. - Contribute to maintaining department documentation such as SOPs (Standard Operating Procedures), QIs (Quality Incidents), and CAPAs (Corrective and Preventive Actions). What you bring to the table: - Approximately 5 years of relevant experience in Regulatory Affairs, including experience in Expanded Access. - Working knowledge of fundamental principles of Pharmacovigilance is required. - Solid understanding of national and international legislation and regulation relating to Expanded Access - A Bachelor’s or Master's degree in Life Sciences or a related field - Experience working directly with clients or external stakeholders in a professional setting - Strong communication skills (written and verbal) in English; able to convey complex topics clearly to both internal teams and external parties. Knowledge of additional languages is a plus - Comfortable collaborating across teams and working in a cross-functional environment - Proactive problem solver with the ability to identify potential regulatory or operational challenges early and suggest practical solutions - Familiarity with Microsoft 365 tools (e.g., Word, Excel, Teams, SharePoint) What we offer: - Impactful work that helps patients gain access to potentially lifesaving treatments. - International work environment, scale-up energy and flat organizational structure which encourages creativity and accountability. - Competitive salary, annual performance bonus and an Employee Stock Option Plan. - Great career development opportunities in a fast-growing company. - Learning and development budget alongside internal knowledge sharing sessions. - Hybrid working model if you're in the Netherlands. - Policies to support working parents. - Healthy lunch at the thriving Amsterdam office. - Unlimited access to professional guidance by certified psychologists via OpenUp - Enjoy monthly events hosted by our vibrant Culture Club as well as an annual ‘myTomorrowland’ company-wide celebration! Equal opportunities myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated. The best work comes from our best selves, and we go to great lengths in supporting our team members to be just that. ", "summaryDescription" : "Regulatory Affairs Pharmacovigilance Manager at myTomorrows. Skills: Pharmacovigilance, Regulatory affairs, Risk management. Manage and oversee pharmacovigilance activities. 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We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and BioPharma – connecting key stakeholders in the drug development ecosystem. We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection. With a global footprint spanning 134 countries, to date we’ve supported over 17,000 patients, 3,000 physicians and 350 sites, earning the trust of 60+ BioPharma companies. In October 2025, we closed a €25M investment with Avego Healthcare Capital to fuel our global ambitions and scale the business. Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today. THE OPPORTUNITY: REGULATORY AFFAIRS DIRECTOR As Regulatory Affairs Director, you will play a critical leadership role in translating our global regulatory strategy into execution across programs, regions, and service lines. You will oversee a portfolio of regulatory activities, ensuring high-quality, compliant, and timely delivery while leading and developing a team of Regulatory Affairs professionals. You’ll work closely with cross-functional teams and act as a senior point of contact for both internal stakeholders and external partners. This role sits at the intersection of strategy, delivery, and leadership, and is key to scaling our Regulatory Affairs capabilities globally. Geographic Requirement: To ensure seamless collaboration with our teams, applicants must reside within the EST or CST time zones. WHAT YOU'LL DO IN THIS ROLE: DRIVE REGULATORY STRATEGY EXECUTION - Translate company and RA/PV strategy into clear regulatory plans across programs and regions - Drive implementation across Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data initiatives OVERSEE PROGRAM AND PORTFOLIO DELIVERY - Oversee multiple regulatory programs simultaneously, ensuring delivery against timelines, quality standards, and client expectations - Identify and proactively manage cross-program risks, dependencies, and resource constraints LEAD AND DEVELOP THE TEAM - Lead, coach, and develop Regulatory Affairs Managers and senior team members - Set clear expectations and drive accountability for performance, quality, and delivery COLLABORATE CROSS-FUNCTIONALLY - Partner closely with Program Management, Medical Affairs, Quality Assurance, and Supply Chain - Ensure regulatory input is embedded into end-to-end program delivery DRIVE OPERATIONAL EXCELLENCE AND PERFORMANCE - Drive standardization, consistency, and scalability of regulatory processes - Identify improvement opportunities and implement data-driven solutions ENGAGE WITH CLIENTS AND STAKEHOLDERS - Act as a senior point of contact for clients on regulatory matters - Support client discussions, audits, and regulatory interactions with Health Authorities ENSURE QUALITY, COMPLIANCE, AND RISK MANAGEMENT - Ensure adherence to global regulatory requirements and internal processes - Support inspection readiness and audit preparedness WHAT YOU BRING TO THE TABLE: - Advanced degree in life sciences, pharmacy, or a related field - Significant experience in Regulatory Affairs within pharma, biotech, or CRO environments - Proven experience managing multiple programs and complex regulatory portfolios - Strong knowledge of global regulatory frameworks (EAP, clinical trials, or similar environments) - Demonstrated leadership experience managing teams and developing talent - Excellent stakeholder management and communication skills Equal opportunities myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated. The best work comes from our best selves, and we go to great lengths in supporting our team members to be just that. 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Established in 2021 by proven industry leaders,", "summaryDescription" : "Director, Regulatory Affairs at Grid United", "createdAt" : "2026-06-14T21:16:27.217", "lastUpdated" : "2026-06-16T00:51:45.889", "ingestTimestamp" : "2026-06-14T21:16:27.217", "mongoId" : "6a0f51a858b93c861e05201b", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 215000, "salaryAnnualMax" : 315000, "salaryBand" : "200k+", "hasSalary" : true, "allSkills" : [ ], "skillCount" : 0, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Director", "dataQualityScore" : 0.7777778, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Energy", "llmIndustryConfidence" : 0.95 }, { "id" : "6a2c8cf574d8ee00a0977c5c", "title" : "Regulatory Affairs Pharmacovigilance Manager", "company" : "myTomorrows", "industry" : "Operations", "salary" : { "min" : 145000.0, "max" : 210000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Manager in the Healthcare industry in the US, adjusted for remote work and experience level." }, "location" : "US, Remote ", "locations" : [ "US, Remote ", "Canada ", "United Kingdom " ], "timestamp" : "2026-06-15T06:37:01.091", "fingerprint" : "de1fa88f12e49e886cbfb59c514138967dfdc82b54862fcd9d2bd0c4f6a8fa7d", "source" : "ashby", "language" : "en", "applyUrl" : "https://jobs.ashbyhq.com/mytomorrows/f90bd4cd-00ad-40da-bd95-80bca7efe655/application", "externalId" : "f90bd4cd-00ad-40da-bd95-80bca7efe655", "industryFunction" : { }, "structuredLocations" : [ { "country" : "United States", "continent" : "na", "workMode" : "remote" } ], "locationText" : "United States", "employmentType" : "FULL_TIME", "experienceLevel" : "Manager", "professionalSkills" : [ "Regulatory strategy", "Risk management", "Legal analysis", "Compliance oversight" ], "hardSkillsList" : [ "Regulatory affairs", "Pharmacovigilance", "Regulatory dossier compilation", "Regulatory documentation", "SOP maintenance", "QI maintenance", "CAPA maintenance" ], "softSkillsList" : [ "Leadership" ], "hardSkills" : [ { "name" : "Regulatory affairs", "level" : "intermediate" }, { "name" : "Pharmacovigilance", "level" : "intermediate" }, { "name" : "Regulatory dossier compilation", "level" : "intermediate" }, { "name" : "Regulatory documentation", "level" : "intermediate" }, { "name" : "SOP maintenance", "level" : "intermediate" }, { "name" : "QI maintenance", "level" : "intermediate" }, { "name" : "CAPA maintenance", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Leadership" } ], "majorSkills" : "Regulatory affairs, Pharmacovigilance, Expanded Access Programs", "majorSkillsList" : [ "Regulatory affairs", "Pharmacovigilance", "Expanded Access Programs" ], "coreResponsibilities" : "Support regulatory strategies for EAPs, Act as Regulatory Affairs expert, Act as Pharmacovigilance expert, Communicate with clients, Submit to Health Authorities, Attend cross-functional meetings, Attend audits, Prepare regulatory dossiers, Compile regulatory dossiers, Submit regulatory dossiers, Provide input for regulatory strategy, Support new EAPs, Ensure compliant handling, Handle regulatory activities, Handle pharmacovigilance activities, Stay up to date on regulations, Assist in drafting documentation, Assist in reviewing documentation, Assist in maintaining documentation, Liaise with Pharmacovigilance provider, Contribute to maintaining SOPs, Contribute to maintaining QIs, Contribute to maintaining CAPAs", "teamCollaboration" : "Collaborate with Medical Affairs; Collaborate with Program Management; Collaborate with Quality Assurance; Collaborate with Supply Chain; Collaborate across teams; Work in cross-functional environment", "domainKnowledge" : "Expanded Access Programs; Biologicals; Cell therapies; Synthetic drugs; National legislation; International legislation", "domainList" : [ "expanded-access-programs", "biologicals", "cell-therapies", "synthetic-drugs", "national-legislation", "international-legislation" ], "domainSpecificKnowledge" : [ "Expanded Access Programs", "Biologicals", "Cell therapies", "Synthetic drugs", "National legislation", "International legislation" ], "toolProficiency" : [ "Microsoft 365", "Word", "Excel", "Teams", "SharePoint" ], "communicationSkills" : "Convey complex topics", "documentationSkills" : "Drafting regulatory documentation; Reviewing regulatory documentation; Maintaining regulatory documentation", "continuousLearning" : "Learning and development budget; Internal knowledge sharing", "problemSolvingSkills" : "Proactive problem solver; 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We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and BioPharma – connecting key stakeholders in the drug development ecosystem. We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection. With a global footprint spanning 134 countries, to date we’ve supported over 17,000 patients, 3,000 physicians and 350 sites, earning the trust of 60+ BioPharma companies. In October 2025, we closed a €25M investment with Avego Healthcare Capital to fuel our global ambitions and scale the business. Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today. The opportunity: Regulatory Affairs & Pharmacovigilance Manager As the Regulatory Affairs and Pharmacovigilance Manager, you will be responsible for ensuring compliance of our processes with country-specific expanded access regulations globally. In this role, you'll be a key contributor to our regulatory and quality infrastructure, keeping us aligned with global legislation. You will be actively working together with Medical Affairs, Program Management, Quality Assurance, and Supply Chain and will report to the Director of Regulatory Affairs and Pharmacovigilance (Emily says hi). Geographic Requirement: For candidates in North America, to ensure seamless collaboration with our teams, applicants must reside within the EST or CST time zones. What you will do in this role: - Support the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs. - Act as the Regulatory Affairs and Pharmacovigilance expert for communications with clients (pharmaceutical companies) and submissions to Health Authorities, as well as cross-functional meetings and audits. - Prepare, compile, and submit regulatory dossiers for cohort and named patient Expanded Access Programs (EAPs) on behalf of clients. - Provide input and support for the regulatory strategy for setting up and executing EAPs (e.g., where, when, and how). - Collaborate with the Commercial team to support new EAPs. - Ensure timely and compliant handling of all regulatory and pharmacovigilance activities related to EAPs. - Stay up to date on relevant global laws, regulations, and guidelines impacting EAPs. - Assist in drafting, reviewing, and maintaining regulatory documentation and templates. - Liaise with the Pharmacovigilance service provider to ensure alignment and compliance. - Contribute to maintaining department documentation such as SOPs (Standard Operating Procedures), QIs (Quality Incidents), and CAPAs (Corrective and Preventive Actions). What you bring to the table: - Approximately 5 years of relevant experience in Regulatory Affairs, including experience in Expanded Access. - Working knowledge of fundamental principles of Pharmacovigilance is required. - Solid understanding of national and international legislation and regulation relating to Expanded Access - A Bachelor’s or Master's degree in Life Sciences or a related field - Experience working directly with clients or external stakeholders in a professional setting - Strong communication skills (written and verbal) in English; able to convey complex topics clearly to both internal teams and external parties. Knowledge of additional languages is a plus - Comfortable collaborating across teams and working in a cross-functional environment - Proactive problem solver with the ability to identify potential regulatory or operational challenges early and suggest practical solutions - Familiarity with Microsoft 365 tools (e.g., Word, Excel, Teams, SharePoint) What we offer: - Impactful work that helps patients gain access to potentially lifesaving treatments. - International work environment, scale-up energy and flat organizational structure which encourages creativity and accountability. - Competitive salary, annual performance bonus and an Employee Stock Option Plan. - Great career development opportunities in a fast-growing company. - Learning and development budget alongside internal knowledge sharing sessions. - Hybrid working model if you're in the Netherlands. - Policies to support working parents. - Healthy lunch at the thriving Amsterdam office. - Unlimited access to professional guidance by certified psychologists via OpenUp - Enjoy monthly events hosted by our vibrant Culture Club as well as an annual ‘myTomorrowland’ company-wide celebration! Equal opportunities myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated. The best work comes from our best selves, and we go to great lengths in supporting our team members to be just that. ", "summaryDescription" : "Regulatory Affairs Pharmacovigilance Manager at myTomorrows. Skills: Regulatory affairs, Pharmacovigilance, Expanded Access Programs. Support regulatory strategies for EAPs. 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33 - Quebec City Office (33 - Quebec City Office)
1020 rue Bouvier
suite 400
Quebec, G2K 0K9

" ], "timestamp" : "2026-06-15T06:46:06.990", "fingerprint" : "6518cf897e4e9534f3f7e8d764ede0e6a2f9a7246c6f2511719a86f3c8cf2507", "source" : "taleo", "language" : "en", "applyUrl" : "https://iamgold.taleo.net/careersection/ex/jobdetail.ftl?job=56981", "externalId" : "56981", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Quebec City", "state" : "Quebec", "country" : "Canada", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "46.8137431,-71.2084061" }, { "country" : "Canada", "continent" : "na", "workMode" : "remote" } ], "locationText" : "Quebec City, Quebec, Canada; Canada", "minimumEducation" : "Bachelor's", "experienceMinYears" : 7, "experienceLevel" : "Manager", "professionalSkills" : [ "Public policy", "Regulatory outcomes", "Relationship building", "Strategic mindset" ], "hardSkillsList" : [ "Regulatory submissions", "Legislative analysis", "Risk analysis" ], "softSkillsList" : [ "Leadership" ], "hardSkills" : [ { "name" : "Regulatory submissions", "level" : "intermediate" }, { "name" : "Legislative analysis", "level" : "intermediate" }, { "name" : "Risk analysis", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Leadership" } ], "majorSkills" : "External affairs, Regulatory affairs, Stakeholder engagement", "majorSkillsList" : [ "External affairs", "Regulatory affairs", "Stakeholder engagement" ], "coreResponsibilities" : "Champion strategic priorities, Build relationships with government, Build relationships with Indigenous communities, Build relationships with key stakeholders, Support strategies influence public policy, Support strategies influence regulatory outcomes, Lead coordination project approval processes, Lead regulatory submissions, Lead communications government authorities, Serve as key liaison, Monitor legislative developments, Analyze legislative developments, Represent IAMGOLD industry associations, Guide senior leadership, Ensure alignment policy positions business objectives", "teamCollaboration" : "Internal teams; Government authorities; Indigenous communities; Key stakeholders; Industry associations", "projectManagementSkills" : [ "Project approval processes" ], "domainKnowledge" : "Quebec legislative regulatory landscape; Mining project approvals", "domainList" : [ "quebec-legislative-regulatory-landscape", "mining-project-approvals" ], "domainSpecificKnowledge" : [ "Quebec legislative regulatory landscape", "Mining project approvals" ], "communicationSkills" : "Stakeholder communications", "documentationSkills" : "Regulatory submissions", "problemSolvingSkills" : "Risk analysis", "specialRequirements" : "20-30% travel, Travel to Quebec sites, Travel to Toronto office", "qualificationsBasic" : "Bachelor's degree, 7 years relevant experience, Work on mining project approvals, Bilingualism French English, Understanding Quebec legislative regulatory landscape", "qualificationsPreferred" : "Experience in Quebec mining project approvals", "remoteFriendly" : true, "workSiteFlexibility" : "Flexible", "rawDescription" : "Empowering People – Extraordinary Performance Start Your Next Opportunity with IAMGOLD IAMGOLD is seeking a Manager, External & Regulatory Affairs to champion IAMGOLD’s strategic priorities in Quebec. This is a unique opportunity to shape the future of our projects by building strong relationships with government, Indigenous communities and other key stakeholders. In this role, you will be responsible for supporting and executing strategies that influence public policy and regulatory outcomes aligned with IAMGOLD’s operations and development projects in Quebec. You will lead the coordination of project approval processes, including regulatory submissions and communications with government authorities, and serve as a key liaison between IAMGOLD and external stakeholders. You will monitor and analyze legislative developments and represent IAMGOLD in industry associations. Your insights will guide senior leadership on political and regulatory risks and opportunities, while your collaboration with internal teams will ensure alignment between policy positions and business objectives. What You Need to Succeed To excel in this role, you’ll need a bachelor’s degree in political science, social sciences, sustainability, or a related field, along with a minimum of 7 years of relevant experience, ideally including work on mining project approvals in Quebec. Bilingualism in French and English is essential, as is a strong understanding of Quebec’s legislative and regulatory landscape. You’ll bring excellent communication and relationship-building skills, along with a strategic mindset and the ability to work independently and collaboratively. We offer an attractive total rewards package that includes a competitive salary and bonus, extended health, dental and insurance benefit coverage, a health spending account, fitness & wellness subsidy, employee & family assistance program, registered pension plan with company match, employee share purchase plan with company match, TFSA & RRSP, electric vehicle subsidy, summer hours and holiday office closure. This role is based in Quebec City with travel required (20–30%) to our sites in Quebec and our Corporate office in Toronto. We can consider remote candidates, depending on their location and travel flexibility. If you are a collaborative leader with a passion for public policy and engagement, we encourage you to apply. We understand no candidate meets every qualification listed. If your experience differs but you believe you can add value to the role, we want to hear from you! We are committed to inclusivity and welcome applications from individuals of all abilities. If you need accommodation during the application process, please contact us, and we'll provide the necessary support. Canada", "summaryDescription" : "Manager, External & Regulatory Affairs at IAMGOLD. Skills: External affairs, Regulatory affairs, Stakeholder engagement. Champion strategic priorities. 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We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and BioPharma – connecting key stakeholders in the drug development ecosystem. We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection. With a global footprint spanning 134 countries, to date we’ve supported over 17,000 patients, 3,000 physicians and 350 sites, earning the trust of 60+ BioPharma companies. In October 2025, we closed a €25M investment with Avego Healthcare Capital to fuel our global ambitions and scale the business. Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today. THE OPPORTUNITY: REGULATORY AFFAIRS DIRECTOR As Regulatory Affairs Director, you will play a critical leadership role in translating our global regulatory strategy into execution across programs, regions, and service lines. You will oversee a portfolio of regulatory activities, ensuring high-quality, compliant, and timely delivery while leading and developing a team of Regulatory Affairs professionals. You’ll work closely with cross-functional teams and act as a senior point of contact for both internal stakeholders and external partners. This role sits at the intersection of strategy, delivery, and leadership, and is key to scaling our Regulatory Affairs capabilities globally. WHAT YOU'LL DO IN THIS ROLE: DRIVE REGULATORY STRATEGY EXECUTION - Translate company and RA/PV strategy into clear regulatory plans across programs and regions - Drive implementation across Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data initiatives OVERSEE PROGRAM AND PORTFOLIO DELIVERY - Oversee multiple regulatory programs simultaneously, ensuring delivery against timelines, quality standards, and client expectations - Identify and proactively manage cross-program risks, dependencies, and resource constraints LEAD AND DEVELOP THE TEAM - Lead, coach, and develop Regulatory Affairs Managers and senior team members - Set clear expectations and drive accountability for performance, quality, and delivery COLLABORATE CROSS-FUNCTIONALLY - Partner closely with Program Management, Medical Affairs, Quality Assurance, and Supply Chain - Ensure regulatory input is embedded into end-to-end program delivery DRIVE OPERATIONAL EXCELLENCE AND PERFORMANCE - Drive standardization, consistency, and scalability of regulatory processes - Identify improvement opportunities and implement data-driven solutions ENGAGE WITH CLIENTS AND STAKEHOLDERS - Act as a senior point of contact for clients on regulatory matters - Support client discussions, audits, and regulatory interactions with Health Authorities ENSURE QUALITY, COMPLIANCE, AND RISK MANAGEMENT - Ensure adherence to global regulatory requirements and internal processes - Support inspection readiness and audit preparedness WHAT YOU BRING TO THE TABLE: - Advanced degree in life sciences, pharmacy, or a related field - Significant experience in Regulatory Affairs within pharma, biotech, or CRO environments - Proven experience managing multiple programs and complex regulatory portfolios - Strong knowledge of global regulatory frameworks (EAP, clinical trials, or similar environments) - Demonstrated leadership experience managing teams and developing talent - Excellent stakeholder management and communication skills Equal opportunities myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated. The best work comes from our best selves, and we go to great lengths in supporting our team members to be just that. ", "summaryDescription" : "Regulatory Affairs Director at myTomorrows. Skills: Regulatory strategy, Program oversight, Team leadership. Drive regulatory strategy execution. Translate strategy into plans", "createdAt" : "2026-06-14T05:35:29.416", "lastUpdated" : "2026-06-15T09:01:37.915", "ingestTimestamp" : "2026-06-14T05:35:29.416", "mongoId" : "6a2c8cf574d8ee00a0977c5b", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "100k-150k", "hasSalary" : false, "allSkills" : [ "Regulatory affairs", "Regulatory compliance", "Health authority interactions", "Leadership", "Mentoring", "Regulatory strategy", "Program oversight", "Team leadership", "Program delivery", "Risk management", "Operational excellence", "Client engagement", "Program management", "Expanded Access Programs", "Clinical Trials", "Real-World Data" ], "skillCount" : 16, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Director", "dataQualityScore" : 0.8888889, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Biotech", "llmIndustryConfidence" : 0.95 }, { "id" : "69dde45b2beec4dd3d9a3ec4", "title" : "Manager, Transfusion Medicine - Quality & Regulatory Affairs", "company" : "City of Hope", "salary" : { "min" : 155000.0, "max" : 220000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Manager in Healthcare in Duarte, CA, adjusted for seniority and company size." }, "location" : "United States-California-Duarte", "locations" : [ "United States-California-Duarte", "Transfusion Medicine", "Hybrid, Days, Days" ], "timestamp" : "2026-06-15T23:52:29.836", "fingerprint" : "429c8ee2965af0a2b3bfce6e453eb8a0dbdf931bd13ecdc0574544477275a4e4", "source" : "taleo", "language" : "en", "applyUrl" : "https://aa067.taleo.net/careersection/ex/jobdetail.ftl?job=207464", "externalId" : "207464", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Duarte", "state" : "California", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "34.1394513,-117.9772873" } ], "locationText" : "Duarte, California, United States", "employmentType" : "FULL_TIME", "minimumEducation" : "Bachelor's", "experienceMinYears" : 5, "experienceLevel" : "Manager", "remoteFriendly" : false, "rawDescription" : "Manager, Quality & Regulatory Affairs Join the transformative team at City of Hope , where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today. The Division of Transfusion Medicine is seeking a dynamic and experienced Manager to lead key initiatives in quality assurance, regulatory compliance, and information systems integration. This pivotal role ensures operational excellence across all areas of the division, while maintaining alignment with institutional values and strategic goals. As a successful candidate, you will: Lead and manage staff responsible for quality, compliance, and regulatory affairs Oversee the integration and compliance of Transfusion Medicine information systems and data across the division Ensure adherence to regulatory standards and maintain licensing/accreditation through direct interaction with external agencies Collaborate with the Director of Transfusion Medicine to implement strategic initiatives that support the division’s mission and vision Drive continuous improvement in operational workflows and data integrity Your qualifications should include: Bachelor of Science degree 5+ years of experience in Blood Banking and blood/cell therapy manufacturing (or equivalent regulated medical manufacturing environment) with 3 years of supervisory experience. California license as a Clinical Laboratory Scientist or Immunohematology limited license; or will obtain either California license within 6 months from date of hire. City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location. City of Hope is an equal opportunity employer. To learn more about our Comprehensive Benefits, please CLICK HERE . 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documentation", "Quality systems", "Safety reporting processes" ], "hardSkillsList" : [ "Regulatory affairs", "Pharmacovigilance", "Expanded Access Programs", "Biologics", "Synthetic drugs", "Regulatory dossiers", "Global regulations", "SOPs", "CAPAs", "Safety reporting" ], "softSkillsList" : [ "Leadership", "Solution-oriented" ], "hardSkills" : [ { "name" : "Regulatory affairs", "level" : "intermediate" }, { "name" : "Pharmacovigilance", "level" : "intermediate" }, { "name" : "Expanded Access Programs", "level" : "intermediate" }, { "name" : "Biologics", "level" : "intermediate" }, { "name" : "Synthetic drugs", "level" : "intermediate" }, { "name" : "Regulatory dossiers", "level" : "intermediate" }, { "name" : "Global regulations", "level" : "intermediate" }, { "name" : "SOPs", "level" : "intermediate" }, { "name" : "CAPAs", "level" : "intermediate" }, { "name" : "Safety reporting", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Leadership" }, { "name" : "Solution-oriented" } ], "majorSkills" : "Regulatory Affairs, Pharmacovigilance, Expanded Access Programs", "majorSkillsList" : [ "Regulatory Affairs", "Pharmacovigilance", "Expanded Access Programs" ], "coreResponsibilities" : "Lead regulatory strategy development for EAPs, Support regulatory strategy development for EAPs, Serve as regulatory SME in client communications, Serve as pharmacovigilance SME in client communications, Serve as regulatory SME in health authority interactions, Serve as pharmacovigilance SME in health authority interactions, Serve as regulatory SME in audits, Serve as pharmacovigilance SME in audits, Serve as regulatory SME in project meetings, Serve as pharmacovigilance SME in project meetings, Prepare regulatory dossiers for EAPs, Compile regulatory dossiers for EAPs, Submit regulatory dossiers for EAPs, Contribute to regulatory approach design for EAP setup, Contribute to regulatory approach execution for EAP setup, Ensure timely execution of regulatory activities, Ensure accurate execution of regulatory activities, Ensure compliant execution of regulatory activities, Ensure timely execution of pharmacovigilance activities, Ensure accurate execution of pharmacovigilance activities, Ensure compliant execution of pharmacovigilance activities, Collaborate with Medical Affairs, Collaborate with Quality Assurance, Collaborate with Program Management, Collaborate with Supply Chain, Collaborate with Commercial teams, Maintain knowledge of global regulations, Maintain knowledge of guidelines impacting Expanded Access, Ensure internal alignment with evolving requirements, Support development of regulatory documentation, Support review of regulatory documentation, Support maintenance of regulatory documentation, Support development of SOPs, Support review of SOPs, Support maintenance of SOPs, Support development of CAPAs, Support review of CAPAs, Support maintenance of CAPAs, Support development of quality systems, Support review of quality systems, Support maintenance of quality systems, Liaise with pharmacovigilance service providers, Ensure end-to-end compliance, Ensure alignment of safety reporting processes", "teamCollaboration" : "Client communications; Health authority interactions; Cross-functional project meetings; Medical Affairs; Quality Assurance; Program Management; Supply Chain; Commercial teams; International environments", "projectManagementSkills" : [ "Project meetings" ], "domainKnowledge" : "Expanded Access Programs; Biologics; Cell and gene therapies; Synthetic drugs; Pharmacovigilance principles; Global safety reporting; Regulatory frameworks", "domainList" : [ "expanded-access-programs", "biologics", "cell-and-gene-therapies", "synthetic-drugs", "pharmacovigilance-principles", "global-safety-reporting", "regulatory-frameworks" ], "domainSpecificKnowledge" : [ "Expanded Access Programs", "Biologics", "Cell and gene therapies", "Synthetic drugs", "Pharmacovigilance principles", "Global safety reporting", "Regulatory frameworks" ], "toolProficiency" : [ "Microsoft 365", "Word", "Excel", "Teams", "SharePoint" ], "communicationSkills" : "Client communication; Health authority interaction; Translate complex concepts", "documentationSkills" : "Regulatory documentation; SOPs; CAPAs", "continuousLearning" : "Internal knowledge-sharing", "problemSolvingSkills" : "Anticipate regulatory risks; Propose practical solutions", "outcomesObjectives" : "Ensure seamless program delivery", "qualificationsBasic" : "5 years of experience in Regulatory Affairs, Foundational knowledge of Pharmacovigilance principles, Knowledge of global safety reporting requirements, Understanding of national regulations governing Expanded Access, Understanding of international regulations governing Expanded Access, Bachelor’s or Master’s degree, Experience working with external stakeholders, Excellent written communication skills, Excellent verbal communication skills, Proficiency with Microsoft 365 tools", "qualificationsPreferred" : "Direct exposure to Expanded Access Programs", "remoteFriendly" : true, "workSiteFlexibility" : "Flexible", "rawDescription" : "## Accountabilities Lead and support regulatory strategy development for Expanded Access Programs (EAPs), including programs involving biologics, cell and gene therapies, and synthetic drugs. Serve as a regulatory and pharmacovigilance subject matter expert in client communications, health authority interactions, audits, and cross-functional project meetings. Prepare, compile, and submit complete regulatory dossiers for both cohort-based and named-patient EAPs on behalf of clients. Contribute to the design and execution of regulatory approaches for EAP setup, including geographic and operational considerations. Ensure timely, accurate, and compliant execution of all regulatory and pharmacovigilance activities related to EAP operations. Collaborate closely with Medical Affairs, Quality Assurance, Program Management, Supply Chain, and Commercial teams to ensure seamless program delivery. Maintain up-to-date knowledge of global regulations and guidelines impacting Expanded Access and ensure internal alignment with evolving requirements. Support the development, review, and maintenance of regulatory documentation, templates, SOPs, CAPAs, and quality systems. Liaise with pharmacovigilance service providers to ensure end-to-end compliance and alignment of safety reporting processes. Requirements: Approximately 5 years of experience in Regulatory Affairs, with direct exposure to Expanded Access Programs strongly preferred. Solid foundational knowledge of Pharmacovigilance principles and global safety reporting requirements. Strong understanding of national and international regulations governing Expanded Access and related regulatory frameworks. Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline. Proven experience working with external stakeholders, including pharmaceutical clients or regulatory authorities. Excellent written and verbal communication skills in English, with the ability to translate complex regulatory concepts into clear guidance. Strong collaboration skills and ability to work effectively in cross-functional, international environments. Proactive, solution-oriented mindset with the ability to anticipate regulatory risks and propose practical solutions. Proficiency with Microsoft 365 tools (Word, Excel, Teams, SharePoint) and comfort working in digital, process-driven environments. Benefits: Competitive salary with annual performance-based bonus Employee Stock Option Plan (ESOP) Learning and development budget and continuous internal knowledge-sharing opportunities Hybrid working flexibility (for eligible regions) and support for work-life balance Policies supporting working parents and caregivers Access to confidential mental health and psychological support services International, mission-driven work environment focused on improving patient access to therapies Regular team events, culture initiatives, and company-wide celebrations Opportunity to contribute directly to impactful work enabling access to potentially life-saving treatments Career growth opportunities within a fast-scaling global organization. ## Additional Information How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1", "summaryDescription" : "Regulatory Affairs Pharmacovigilance Manager. Skills: Regulatory Affairs, Pharmacovigilance, Expanded Access Programs. Lead regulatory strategy development for EAPs. Support regulatory strategy development for EAPs", "postedDate" : "2026-06-12T14:51:05.100", "createdAt" : "2026-06-12T14:51:05.100", "lastUpdated" : "2026-06-15T23:59:41.892", "ingestTimestamp" : "2026-06-14T22:07:00.714", "mongoId" : "6a2cb20f74d8ee00a09df901", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 135000, "salaryAnnualMax" : 195000, "salaryBand" : "100k-150k", "hasSalary" : true, "allSkills" : [ "Regulatory affairs", "Pharmacovigilance", "Expanded Access Programs", "Biologics", "Synthetic drugs", "Regulatory dossiers", "Global regulations", "SOPs", "CAPAs", "Safety reporting", "Leadership", "Solution-oriented", "Regulatory Affairs", "Regulatory strategy", "Client communication", "Health authority interaction", "Cross-functional project management", "Regulatory dossier preparation", "Regulatory approach design", "Program delivery", "Regulatory documentation", "Quality systems", "Safety reporting processes", "Project meetings", "Cell and gene therapies", "Pharmacovigilance principles", "Global safety reporting", "Regulatory frameworks", "Microsoft 365", "Word", "Excel", "Teams", "SharePoint" ], "skillCount" : 33, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Manager", "dataQualityScore" : 0.8888889, "daysOld" : 3, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Pharma", "llmIndustryConfidence" : 0.95 }, { "id" : "6a2c5eb374d8ee00a08e6055", "title" : "Clinical & Regulatory Affairs", "company" : "Anteris Technologies", "industry" : "Healthcare", "salary" : { "min" : 95000.0, "max" : 135000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a mid-seniority Clinical & Regulatory Affairs role in Eagan, United States, adjusted for the biotech industry." }, "location" : "Eagan, Minnesota, United States", "locations" : [ "Eagan", "Minnesota", "United States", "Geneva", "Switzerland", "Maple Grove", "Minnesota", "United States", "Remote - EU", "United States" ], "timestamp" : "2026-06-15T00:31:00.279", "fingerprint" : "98199fcca4b76d717e4a5b15bd87ba74d173e7963e564b8b3649405081a23046", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.greenhouse.io/anteristech/jobs/5222699008", "externalId" : "5222699008", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Eagan", "state" : "Minnesota", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "44.8181730,-93.1659179" } ], "locationText" : "Eagan, Minnesota, United States", "domainKnowledge" : "Structural heart; Cardiac care; Transcatheter Aortic Valve Replacement; Medical device; Global regulatory compliance; Clinical trial management", "domainList" : [ "structural-heart", "cardiac-care", "transcatheter-aortic-valve-replacement", "medical-device", "global-regulatory-compliance", "clinical-trial-management" ], "domainSpecificKnowledge" : [ "Structural heart", "Cardiac care", "Transcatheter Aortic Valve Replacement", "Medical device", "Global regulatory compliance", "Clinical trial management" ], "outcomesObjectives" : "Advance breakthrough therapies through development; Advance breakthrough therapies through commercialization", "workSiteFlexibility" : "Onsite", "rawDescription" : "Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve. Anteris Technologies is advancing innovative structural heart technologies designed to redefine expectations in the treatment of aortic stenosis. Our Clinical and Regulatory Affairs teams play a critical role in supporting clinical research, physician engagement, global regulatory strategy, and the advancement of breakthrough therapies through development and commercialization. We are interested in connecting with professionals with the following experience: Clinical operations Clinical monitoring Physician support Field clinical education Global regulatory compliance, or Clinical trial management within the medical device industry. Roles in Clinical & Regulatory Affairs include: Clinical Project Manager Clinical Research Associate Clinical Research Scientist Clinical Specialist Regulatory Affairs Specialist Candidates with experience supporting Class III medical devices, structural heart therapies, cardiovascular technologies, or global clinical studies are especially encouraged to apply. Successful candidates are collaborative, adaptable, organized, and comfortable operating within fast-paced, cross-functional environments. This is an opportunity to contribute directly to meaningful innovation while helping bring transformative therapies to patients worldwide. What We Offer: Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies. Collaborative and dynamic work environment with a culture of innovation and excellence. Competitive compensation package, including salary, performance-based bonuses, and stock options. Career development opportunities and a chance to be part of a growing company that values its employees. Health and Wellness Offerings: Medical, Dental, and Vision Plans Flexible Spending Account (FSA) 401k + Company Match Life, AD&D, Short Term and Long-Term Disability Insurance Bonus Plan Eligibility Employee Equity Program Paid Holidays & Vacation Employee Assistance Program Inclusive Team Environment These evergreen postings are designed to connect us with talented individuals interested in future opportunities at Anteris Technologies. Because openings may vary over time, additional details regarding specific responsibilities, qualifications, work arrangements, and compensation will be shared as candidates move forward in the process for individual roles. Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations. Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.", "summaryDescription" : "Clinical & Regulatory Affairs at Anteris Technologies", "postedDate" : "2026-06-12T22:07:07.379", "createdAt" : "2026-06-12T22:07:07.379", "lastUpdated" : "2026-06-15T00:31:00.279", "ingestTimestamp" : "2026-06-12T22:07:07.379", "mongoId" : "6a2c5eb374d8ee00a08e6055", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 95000, "salaryAnnualMax" : 135000, "salaryBand" : "75k-100k", "hasSalary" : true, "allSkills" : [ "Structural heart", "Cardiac care", "Transcatheter Aortic Valve Replacement", "Medical device", "Global regulatory compliance", "Clinical trial management" ], "skillCount" : 6, "jobCategory" : "other", "jobSubcategory" : "clinical", "dataQualityScore" : 0.7777778, "daysOld" : 2, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Healthcare" }, { "id" : "6a2b975674d8ee00a0816d18", "title" : "Regulatory Affairs Specialist", "company" : "Medtronic", "industry" : "Healthcare", "salary" : { "min" : 7500000.0, "max" : 1.2E7, "currency" : "ARS", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Mid-level Regulatory Affairs Specialist in Buenos Aires, Argentina, adjusted for the Healthcare industry and Medtronic's company size." }, "location" : "Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina", "locations" : [ "Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina" ], "certifications" : [ "GMP", "GDP", "ISO 13485" ], "timestamp" : "2026-06-14T22:21:27.909", "fingerprint" : "76ff153ab5d77b0f93cca2d8520451080a8edaf4ec33ef32319db898e6274064", "source" : "workday", "language" : "es", "applyUrl" : "https://medtronic.wd1.myworkdayjobs.com/RedeploymentMedtronicCareers/job/Buenos-Aires-Ciudad-Autnoma-de-Buenos-Aires-Argentina/Regulatory-Affairs-Specialist--Argentina_R67027", "externalId" : "R67027", "industryFunction" : { }, "locationPoint" : "-5.2671,-79.96759", "structuredLocations" : [ { "city" : "Buenos Aires", "state" : "Ciudad Autónoma de Buenos Aires", "country" : "Argentina", "continent" : "sa", "source" : "llm", "workMode" : "hybrid", "geo" : "-34.6095579,-58.3887904" } ], "locationText" : "Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina", "employmentType" : "FULL_TIME", "experienceMinYears" : 2, "experienceMaxYears" : 3, "professionalSkills" : [ "Regulatory affairs", "Documentation preparation", "Regulatory submissions", "License renewal", "Annual registrations", "Labeling changes", "Manufacturing changes", "Marketing changes", "Clinical protocols", "Regulatory compliance", "Tracking systems", "Control systems", "Regulatory procedures", "Regulatory changes", "Agency interaction", "Clinical trial applications" ], "hardSkillsList" : [ "Regulatory filing", "Validation", "Modification", "Registration", "Audit", "CAPA" ], "softSkillsList" : [ "Leadership" ], "hardSkills" : [ { "name" : "Regulatory filing", "level" : "intermediate" }, { "name" : "Validation", "level" : "intermediate" }, { "name" : "Modification", "level" : "intermediate" }, { "name" : "Registration", "level" : "intermediate" }, { "name" : "Audit", "level" : "intermediate" }, { "name" : "CAPA", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Leadership" } ], "majorSkills" : "Regulatory Affairs, Medical Devices, Argentina Regulations", "majorSkillsList" : [ "Regulatory Affairs", "Medical Devices", "Argentina Regulations" ], "coreResponsibilities" : "Coordinate and prepare documentation for regulatory submissions, Prepare documentation for internal audits and inspections, Compile materials for submissions, Compile materials for license renewal, Compile materials for annual registrations, Recommend changes to labeling, Recommend changes to manufacturing, Recommend changes to marketing, Recommend changes to clinical protocols, Ensure regulatory compliance, Improve tracking systems, Improve control systems, Stay up-to-date on regulatory procedures, Stay up-to-date on regulatory changes, Interact with regulatory agencies, Recommend strategies for clinical trial approval", "teamCollaboration" : "Cross-functional teams", "domainKnowledge" : "Medical devices; Argentinian regulations; COFEPRIS; ANMAT; DIGEMID; Good Practices; ISO 13485", "domainList" : [ "medical-devices", "argentinian-regulations", "cofepris", "anmat", "digemid", "good-practices", "iso-13485" ], "domainSpecificKnowledge" : [ "Medical devices", "Argentinian regulations", "COFEPRIS", "ANMAT", "DIGEMID", "Good Practices", "ISO 13485" ], "documentationSkills" : "Regulatory filings", "continuousLearning" : "Mentoring; Networking", "qualificationsBasic" : "Carrera universitaria Químico Farmacéutico Biólogo, Ingeniería Biomédica, Medicina, Ingeniería Química o experiencia práctica en procesos regulatorios, Dos a tres años de experiencia relevante trabajando con asuntos regulatorios en empresas de dispositivos médicos en Argentina, Inglés Avanzado, Experiencia realizando/validando renovaciones y modificaciones de Registros Sanitarios, Experiencia trabajando con entidades de gobierno como COFEPRIS (México), ANMAT (Argentina) & DIGEMID (Perú)", "qualificationsPreferred" : "Experiencia en registros sanitarios de dispositivos médicos, Experiencia en Auditorías internas y externas / CAPA, Certificados de Buenas prácticas (GMP, GDP) & ISO 13485", "remoteFriendly" : false, "workSiteFlexibility" : "Hybrid", "rawDescription" : "At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. # **A Day in the Life** Somos líderes en tecnología y soluciones médicas impulsados por una misión, con un legado de integridad e innovación. Trabaja con nosotros para incentivar una mejor atención al paciente y colabora con toda la industria para que la asistencia sanitaria sea más asequible y accesible. Forma parte de una comunidad de expertos comprometidos con garantizar una asistencia sanitaria de calidad y asequible en todo el mundo. Venga a fortalecer sus habilidades especializadas y a mejorar su experiencia. Le apoyaremos con la formación, la tutoría, la orientación y las redes que necesita para avanzar, y le capacitaremos para que trabaje de la manera que más le convenga. Juntos, podemos afrontar los retos que cambiarán el panorama de la asistencia sanitaria. Únase a nosotros para desarrollar una carrera que cambia vidas. El puesto estará ubicado en Argentina CABA en un modelo híbrido. **Las responsabilidades pueden incluir las siguientes y se pueden asignar otras tareas:** * Dirige o lleva a cabo la coordinación y preparación de los expedientes de documentación para las presentaciones reglamentarias de todas las áreas de la empresa, así como para las auditorías e inspecciones internas. * Dirige o recopila todos los materiales necesarios para las presentaciones, la renovación de licencias y los registros anuales. * Recomienda cambios en el etiquetado, la fabricación, la comercialización y los protocolos clínicos para garantizar el cumplimiento normativo. * Supervisa y mejora los sistemas de seguimiento y control. * Se mantiene al día de los procedimientos y cambios normativos. * Puede dirigir la interacción con las agencias reguladoras en asuntos definidos. * Recomienda estrategias para la aprobación lo más temprana posible de las solicitudes de ensayos clínicos. **Conocimientos y experiencia requeridos:** * Carrera universitaria de Químico Farmacéutico Biólogo, Ingeniería Biomédica, Medicina, Ingeniería Química y/o experiencia práctica en procesos regulatorios. * Dos a tres años de experiencia relevante trabajando con asuntos regulatorios en empresas de dispositivos médicos en Argentina * Inglés Avanzado * Experiencia realizando/ validando, renovaciones & modificaciones de Registros Sanitarios * Experiencia trabajando con entidades de gobierno como COFEPRIS (México), ANMAT (Argentina) & DIGEMID (Perú) * Sería una ventaja contar con experiencia en registros * sanitarios de dispositivos médicos * Sería una ventaja contar con experiencia en Auditorías internas y externas / CAPA (Corrective and Preventive Actions) * Sería una ventaja contar con certificados de Buenas prácticas (GMP, GDP) & ISO 13485 * Ubicación de la vacante: Argentina CABA **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. # **Benefits & Compensation** **Medtronic offers a competitive Salary and flexible Benefits Package** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). # **About Medtronic** # We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity [here](http://www.medtronic.com)", "summaryDescription" : "Regulatory Affairs Specialist at Medtronic. Skills: Regulatory Affairs, Medical Devices, Argentina Regulations. Coordinate and prepare documentation for regulatory submissions. 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Partner with internal teams", "projectManagementSkills" : [ "Project management", "Manage multiple deadlines", "Coordinate contributors", "Escalate risks" ], "domainKnowledge" : "Global regulations; Product registration; Labeling regulations; Post-approval changes; Lifecycle management; Regulatory frameworks; Health authority guidelines; Manufacturing regulations; Quality regulations; Safety regulations", "domainList" : [ "global-regulations", "product-registration", "labeling-regulations", "post-approval-changes", "lifecycle-management", "regulatory-frameworks", "health-authority-guidelines", "manufacturing-regulations", "quality-regulations", "safety-regulations" ], "domainSpecificKnowledge" : [ "Global regulations", "Product registration", "Labeling regulations", "Post-approval changes", "Lifecycle management", "Regulatory frameworks", "Health authority guidelines", "Manufacturing regulations", "Quality regulations", "Safety regulations" ], "communicationSkills" : "Written communication; Verbal communication; Clear documentation; Influence stakeholders; Agency communications; Rapid responses", "documentationSkills" : "Regulatory documentation; Dossier preparation; Labeling text; Submission timelines; Risk assessments", "continuousLearning" : "Keep learning; Deepen expertise; Explore new areas; Coaching; Mentorship", "problemSolvingSkills" : "Resolve issues; Problem solving", "outcomesObjectives" : "Faster approvals; Secure timely registrations; Optimize product value; Deliver right-first-time quality; Maintain market continuity; Accelerate patient access", "qualificationsBasic" : "Bachelor’s degree in pharmacy, Experience in regulatory affairs, Understanding of regulatory frameworks, Written and verbal communication skills, Project management skills, Focus on details, accuracy, documentation quality, and compliance", "qualificationsPreferred" : "Strategic thinking, Regulatory judgment, Stakeholder management, Planning and prioritization, Risk assessment, Problem solving, Cross functional collaboration, Decision making", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "**Job title: Regulatory Affairs Manager** **Introduction to role:** Are you ready to turn complex global regulations into faster approvals that put life-changing medicines in patients’ hands? In this role, you will lead regulatory strategy and execution across development and lifecycle, guiding submissions and health authority interactions to secure timely registrations. You will translate evolving requirements into decisive plans that align teams, reduce risk, and enable confident, on-time delivery. Can you see yourself shaping the path from first dossier outline to final approval while building capability around you? **Accountabilities:** * **Regulatory Strategy:** Develop and implement regulatory strategies for product registration, labeling, post-approval changes, and lifecycle management to accelerate approvals and optimize product value. * **Submission Management:** Lead or coordinate the preparation, review, and submission of regulatory dossiers, variations, renewals, and responses to questions, delivering right-first-time quality and region-specific compliance. * **Health Authority Engagement:** Plan, support, or lead agency communications, including meeting requests, briefing documents, and rapid, clear responses and follow-up that build credibility and trust. * **Compliance and Standards:** Ensure all activities align with regulations, guidance, company policies, and submission standards; champion inspection readiness and a culture of quality. * **Cross-Functional Collaboration:** Partner with internal teams to gather required documentation, align regulatory plans with project milestones, and resolve issues quickly to protect timelines. * **Labeling Support:** Contribute to the development, review, and maintenance of product labeling, artwork, and regulatory text to ensure accuracy and alignment with scientific and commercial objectives. * **Change Control and Lifecycle Management:** Assess regulatory impact of manufacturing, quality, safety, or labeling changes; define and deliver required submissions to maintain market continuity and product compliance. * **Planning and tracking:** Build and maintain submission timelines, regulatory risk assessments, and documentation that enable transparent decision-making and inform business planning. **Essential Skills/Experience:** * Bachelor’s degree in pharmacy. * Strong experience in regulatory affairs * Strong understanding of relevant regulatory frameworks and other applicable requirements. * Strong written and verbal communication skills, including the ability to prepare clear regulatory documentation and influence stakeholders. * Strong Project management skills with the ability to manage multiple deadlines, coordinate contributors, and escalate risks appropriately. * Strong focus on details, accuracy, documentation quality, and compliance. **Desirable Skills/Experience:** * Strategic thinking * Regulatory judgment * Stakeholder management * Planning and prioritization * Risk assessment * Problem solving * Cross functional collaboration * Decision making **Why AstraZeneca?** Here you will work with specialists who are empowered to influence decisions across the enterprise, combining bold ideas with disciplined delivery to move fast without compromising on quality. We bring unexpected teams together—policy shapers, scientists, technologists, and regulatory experts—to challenge assumptions and spark better solutions. You will be encouraged to keep learning, deepen your expertise, and explore new areas with coaching and mentorship that match your ambition. We value kindness alongside ambition, and we balance a dynamic, change-driven environment with the rigour required by government procedures—so your work directly accelerates patient access while advancing your career. If you are ready to lead regulatory strategy that turns science into approvals and measurable patient impact, take the next step and shape what comes next with us today! **Date Posted** 10-يونيو-2026 **Closing Date** 29-يونيو-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.", "summaryDescription" : "Regulatory Affairs Manager at AstraZeneca. Skills: Regulatory strategy, Submission management, Health authority engagement, Compliance. Develop regulatory strategies. Implement regulatory strategies", "postedDate" : "2026-06-11T02:23:58.366", "createdAt" : "2026-06-12T02:23:58.319", "lastUpdated" : "2026-06-14T22:43:26.705", "ingestTimestamp" : "2026-06-12T02:23:58.319", "mongoId" : "6a2af78274d8ee00a073d614", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "sourceUrl" : "https://astrazeneca.wd3.myworkdayjobs.com/Careers/job/Egypt/Regulatory-Affairs-Manager_R-254239-1", "salaryBand" : "200k+", "hasSalary" : false, "allSkills" : [ "Regulatory filing", "Dossier preparation", "Response writing", "Submission management", "Labeling development", "Change assessment", "Regulatory strategy", "Health authority engagement", "Compliance", "Lifecycle management", "Product registration", "Labeling", "Post-approval changes", "Regulatory dossiers", "Health authority interactions", "Agency communications", "Quality culture", "Change control", "Market continuity", "Product compliance", "Risk assessments", "Transparent decision-making", "Business planning", "Project management", "Manage multiple deadlines", "Coordinate contributors", "Escalate risks", "Global regulations", "Labeling regulations", "Regulatory frameworks", "Health authority guidelines", "Manufacturing regulations", "Quality regulations", "Safety regulations" ], "skillCount" : 34, "jobCategory" : "other", "seniorityLevel" : "manager", "dataQualityScore" : 1.0, "daysOld" : 3, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Healthcare" }, { "id" : "6a2c7b5d74d8ee00a094954b", "title" : "Senior International Regulatory Affairs Specialist", "company" : "Butterfly Network", "industry" : "Healthcare", "salary" : { "min" : 110000.0, "max" : 115000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : false }, "location" : "Burlington, Massachusetts, United States", "locations" : [ "Burlington", "Massachusetts", "United States", "New York", "New York", "United States" ], "timestamp" : "2026-06-15T07:45:52.304", "fingerprint" : "08e1e8f61dbbb6d7fe22168299ba7f62f6d7c6e94f6f78f99e3176a1799da48f", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://www.butterflynetwork.com/careers?gh_jid=7733539003", "externalId" : "7733539003", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Burlington", "state" : "Massachusetts", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "42.5048167,-71.1956111" } ], "locationText" : "Burlington, Massachusetts, United States", "experienceMinYears" : 5, "experienceMaxYears" : 10, "experienceLevel" : "Senior", "professionalSkills" : [ "Regulatory strategy", "Market access", "Risk management", "Compliance oversight", "Legal analysis" ], "hardSkillsList" : [ "Regulatory affairs", "Medical device submissions", "Product change assessment", "Global regulatory pathways", "Post-market surveillance", "Audit readiness" ], "hardSkills" : [ { "name" : "Regulatory affairs", "level" : "intermediate" }, { "name" : "Medical device submissions", "level" : "intermediate" }, { "name" : "Product change assessment", "level" : "intermediate" }, { "name" : "Global regulatory pathways", "level" : "intermediate" }, { "name" : "Post-market surveillance", "level" : "intermediate" }, { "name" : "Audit readiness", "level" : "intermediate" } ], "majorSkills" : "International regulatory affairs, Medical device regulations, Global market access, Regulatory submissions", "majorSkillsList" : [ "International regulatory affairs", "Medical device regulations", "Global market access", "Regulatory submissions" ], "coreResponsibilities" : "Support global regulatory strategies, Support Class II devices, Support Software in Medical Device, Coordinate international regulatory submissions, Prepare regulatory submission documentation, Integrate cross-functional inputs, Support timelines and deliverables, Maintain product registrations, Maintain renewals, Maintain amendments, Ensure compliance, Partner with cross-functional teams, Escalate issues, Escalate resource needs, Support post-market regulatory activities, Support renewals, Support variations, Support compliance maintenance, Maintain awareness of global regulations, Support audit readiness", "teamCollaboration" : "Cross-functional teams; Product development teams; Software development teams; Quality Assurance; Engineering", "domainKnowledge" : "Medical devices; Software in Medical Device; EU MDR 2017/745; MDSAP; APAC; MEA; LATAM; ISO 13485; ISO 14971; IEC 62304; Quality Management System", "domainList" : [ "medical-devices", "software-in-medical-device", "eu-mdr-2017-745", "mdsap", "apac", "mea", "latam", "iso-13485", "iso-14971", "iec-62304", "quality-management-system" ], "domainSpecificKnowledge" : [ "Medical devices", "Software in Medical Device", "EU MDR 2017/745", "MDSAP", "APAC", "MEA", "LATAM", "ISO 13485", "ISO 14971", "IEC 62304", "Quality Management System" ], "documentationSkills" : "Regulatory submission documentation", "problemSolvingSkills" : "Risk identification; Solution identification", "outcomesObjectives" : "Enable global market access; Drive high-quality submissions; Keep programs on track", "qualificationsBasic" : "Bachelor's degree, 5+ years regulatory affairs, Class II or higher devices, Software-enabled medical devices, Software in Medical Device, Software as Medical Device, International regulatory submissions, MDSAP countries, APAC, MEA, LATAM, EU MDR 2017/745, ISO 13485, ISO 14971, IEC 62304, Quality Management System, Change control, Design control, Lifecycle management", "qualificationsPreferred" : "Advanced degree preferred", "workSiteFlexibility" : "Hybrid", "rawDescription" : "Senior International Regulatory Affairs Specialist Company Description Butterfly Network, Inc. (NYSE: BFLY) is driving a digital revolution in ultrasound imaging and sensing with its proprietary Ultrasound-on-Chip™ semiconductor technology and software solutions. Butterfly first proved its technology in the point-of-care ultrasound market – commercializing the world’s first single-probe, whole-body portable ultrasound device, which is now on its best-selling, third-generation: Butterfly iQ3™. The Company combines its advanced hardware with cloud software and AI, an enterprise workflow solution (Compass AI™) and other offerings to drive adoption of affordable, accessible ultrasound. Butterfly also enables third-party development of imaging AI apps through Butterfly Garden™, its software development kit and AI partnership initiative. In addition to its medical imaging products, Butterfly Embedded™ is the Company’s Ultrasound-on-Chip™ licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond. Through Butterfly Embedded™, partners can build and scale novel ultrasound applications powered by Butterfly’s proprietary semiconductor chip and software platform. Butterfly’s innovations have been recognized by Prix Galien USA, Fierce 50, TIME’s Best Inventions and Fast Company’s World Changing Ideas, among other achievements. We’re a team of bold thinkers, problem-solvers, and innovators ready to shape the future of medical imaging. Let’s build something extraordinary together! Job Description As a Senior Specialist, International Regulatory Affairs at Butterfly Network, you will play a key role in enabling global market access for innovative, hardware and software medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating countries. This role requires a strong ability to translate evolving regulatory requirements—such as EU MDR 2017/745—into clear, actionable plans, while partnering cross-functionally to align regulatory expectations with fast-paced product and software development cycles. You will assess the impact of product and software changes, navigate global regulatory pathways, and proactively identify risks and solutions to keep programs on track. Success in this role requires a highly organized, analytical, and self-driven regulatory professional who is comfortable operating in a dynamic environment, managing competing priorities, and contributing to the advancement of cutting-edge healthcare technologies on a global scale. As part of our team, your core responsibilities will be: Support execution of global regulatory strategies for Class II and higher medical devices, including Software in a Medical Device (SiMD) Contribute to and coordinate international regulatory submissions and registrations across APAC, MEA, LATAM, and MDSAP-participating countries Prepare and manage regulatory submission documentation, integrating cross-functional inputs and supporting timelines and deliverables Maintain product registrations, renewals, and amendments in accordance with country-specific requirements to support global market access Ensure compliance with global regulatory frameworks, including EU MDR 2017/745 and other applicable standards and regulations Partner with cross-functional teams (R escalate issues and resource needs as appropriate Support post-market regulatory activities, including renewals, variations, and compliance maintenance while maintaining awareness of evolving global regulations and supporting audit readiness within a QMS-driven environment Qualifications Baseline skills/experiences/attributes: Bachelor’s degree in a scientific, engineering, or related discipline (advanced degree preferred) At least 5+ years of progressive regulatory affairs experience in the medical device industry, including Class II or higher devices Demonstrated experience with software-enabled medical devices, including Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD) Proven track record of supporting international regulatory submissions and market expansion, with hands-on experience across multiple regions, including: MDSAP countries, APAC, MEA and LATAM Strong working knowledge of global regulatory frameworks, including EU MDR 2017/745, and solid familiarity with international standards such as ISO 13485, ISO 14971, and IEC 62304 Experience operating within a Quality Management System (QMS), with exposure to structured regulatory processes such as change control, design control, and lifecycle management Ability to manage multiple projects and competing priorities in a fast-paced environment Strong verbal and written communication and presentation skills, with the ability to communicate clearly and effectively in English Demonstrated ability to ethical judgment within regulatory frameworks and company policies Collaborative team player with a service-oriented mindset; flexible and proactive in adapting to changing business needs Independent thinker with the ability to identify problems and develop creative, compliant solutions. Ideally, you also have these skills/experiences/attributes (but it’s ok if you don’t!): Experience in Artificial Intelligence/Machine Learning (AI/ML) Regulatory Affairs Certification (RAC). Values Innovation is what we do. Our values are how we make it happen. Butterflies are and believe in… Patient-Centric Innovators: Our mission is THE mission. Empowered to Impact: Every voice matters. One Team, One Goal: Unity fuels progress. Growth Champions: We embrace challenges. Action-Oriented Achievers: We follow through, every time. Location Butterfly offers a hybrid work model for most positions, with team members spending two or more days a week in the office. While flexibility is key, we value in-person connections that spark creativity and teamwork. Our offices are designed for collaboration, with comfortable workspaces, stocked kitchens, and opportunities to connect with peers. This is a hybrid position that can be based in Burlington, MA or New York City, NY Benefits and Perks Comprehensive health insurance, encompassing dental and vision coverage, is provided to all our employees. As a health-tech company, we prioritize the well-being of our teams. Additionally, employees have the option to buy up for enhanced health insurance coverage. We also contribute to Health Savings Account (HSA) accounts for all enrolled employees on an annual basis. Comprehensive Employee Assistance Program - we provide access to tools and resources to support your emotional health and day-to-day needs. 401k plan and match - we facilitate your retirement goals. Eligible employees will have the opportunity to participate in Employee Stock Purchase Plan (ESPP) Unlimited Paid Time Off + 10 Holiday Days a Year - recharge and come back ready to make an impact Parental Leave - we aim to provide our employees with time to bond with their growing family, along with additional support for primary caregivers to help transition back to work Competitive salaried compensation - we value our employees and show it Equity - we want every employee to be a stakeholder The opportunity to build a revolutionary healthcare product and save millions of lives! Compensation Our estimated salary for this role is $110,000 - $115,000 + bonus + equity + benefits. Actual pay is determined by multiple factors such as skills, qualifications, experience and market demand. For this role, we are only considering candidates who are legally authorized to work in the United States and who do not now or in the future require sponsorship for employment visa status. Butterfly Network does not accept agency resumes. Butterfly Network is an E-Verify Company. Butterfly Network is an equal opportunity employer. Regardless of race, traits associated with race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines. Butterfly requires security adherence responsibilities from all employees. These include: adhering to all company security policies and procedures, utilize provided company assets securely, and complete all required security awareness training programs. Safeguarding company data and systems from unauthorized access, modification, or destruction, contributing to the overall security posture of the organization. Immediately reporting any suspected or actual security incidents, including phishing attempts, malware infections, or unauthorized access, following the established incident response procedures. #LI-KG #KG-LI", "summaryDescription" : "Senior International Regulatory Affairs Specialist at Butterfly Network. Skills: International regulatory affairs, Medical device regulations, Global market access, Regulatory submissions. Support global regulatory strategies. Support Class II devices", "postedDate" : "2026-06-13T21:03:59.367", "createdAt" : "2026-06-13T21:03:59.367", "lastUpdated" : "2026-06-15T07:45:52.304", "ingestTimestamp" : "2026-06-13T21:03:59.367", "mongoId" : "6a2c7b5d74d8ee00a094954b", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 110000, "salaryAnnualMax" : 115000, "salaryBand" : "100k-150k", "hasSalary" : true, "allSkills" : [ "Regulatory affairs", "Medical device submissions", "Product change assessment", "Global regulatory pathways", "Post-market surveillance", "Audit readiness", "International regulatory affairs", "Medical device regulations", "Global market access", "Regulatory submissions", "Regulatory strategy", "Market access", "Risk management", "Compliance oversight", "Legal analysis", "Medical devices", "Software in Medical Device", "EU MDR 2017/745", "MDSAP", "APAC", "MEA", "LATAM", "ISO 13485", "ISO 14971", "IEC 62304", "Quality Management System" ], "skillCount" : 26, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Senior", "dataQualityScore" : 0.8888889, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Healthcare", "llmIndustryConfidence" : 0.98 }, { "id" : "6a2a7bcf74d8ee00a06646d5", "title" : "Regulatory Affairs Pharmacovigilance Manager", "company" : "myTomorrows", "industry" : "Operations", "salary" : { "min" : 150000.0, "max" : 210000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market data for a Manager in Regulatory Affairs Pharmacovigilance in the US Biotech industry, adjusted for remote work and manager seniority." }, "location" : "US, Remote ", "locations" : [ "US, Remote ", "Canada ", "United Kingdom " ], "timestamp" : "2026-06-12T21:09:59.500", "fingerprint" : "fa17ff3265ab175b2775203bc20d283ce45e4fc14eb759a025c91522d4c5455b", "source" : "ashby", "language" : "en", "applyUrl" : "https://jobs.ashbyhq.com/myTomorrows/f90bd4cd-00ad-40da-bd95-80bca7efe655/application", "externalId" : "f90bd4cd-00ad-40da-bd95-80bca7efe655", "industryFunction" : { }, "structuredLocations" : [ { "country" : "United States", "continent" : "na", "workMode" : "remote" } ], "locationText" : "United States", "employmentType" : "FULL_TIME", "experienceLevel" : "Manager", "professionalSkills" : [ "Regulatory strategy", "Regulatory affairs", "Pharmacovigilance", "Expanded Access Programs" ], "hardSkillsList" : [ "Regulatory submissions", "Dossier preparation", "Regulatory documentation" ], "softSkillsList" : [ "Problem solver" ], "hardSkills" : [ { "name" : "Regulatory submissions", "level" : "intermediate" }, { "name" : "Dossier preparation", "level" : "intermediate" }, { "name" : "Regulatory documentation", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Problem solver" } ], "majorSkills" : "Regulatory Affairs, Pharmacovigilance, Expanded Access", "majorSkillsList" : [ "Regulatory Affairs", "Pharmacovigilance", "Expanded Access" ], "coreResponsibilities" : "Support regulatory strategies for EAPs, Act as RA/PV expert, Communicate with clients, Submit to Health Authorities, Attend cross-functional meetings, Attend audits, Prepare regulatory dossiers for EAPs, Compile regulatory dossiers for EAPs, Submit regulatory dossiers for EAPs, Provide input for regulatory strategy, Support setting up EAPs, Support executing EAPs, Collaborate with Commercial team, Ensure compliant handling of regulatory activities, Ensure compliant handling of pharmacovigilance activities, Stay up to date on global laws, Stay up to date on regulations, Stay up to date on guidelines, Assist in drafting documentation, Assist in reviewing documentation, Assist in maintaining documentation, Liaise with Pharmacovigilance provider, Contribute to maintaining SOPs, Contribute to maintaining QIs, Contribute to maintaining CAPAs", "teamCollaboration" : "Working with Medical Affairs; Working with Program Management; Working with Quality Assurance; Working with Supply Chain; Collaborating across teams; Working in cross-functional environment", "domainKnowledge" : "Expanded Access Regulations; Biologicals; Cell therapies; Synthetic drugs; National legislation; International legislation", "domainList" : [ "expanded-access-regulations", "biologicals", "cell-therapies", "synthetic-drugs", "national-legislation", "international-legislation" ], "domainSpecificKnowledge" : [ "Expanded Access Regulations", "Biologicals", "Cell therapies", "Synthetic drugs", "National legislation", "International legislation" ], "toolProficiency" : [ "Microsoft 365", "Word", "Excel", "Teams", "SharePoint" ], "communicationSkills" : "Convey complex topics", "documentationSkills" : "Drafting documentation; Reviewing documentation; Maintaining documentation", "continuousLearning" : "Internal knowledge sharing", "problemSolvingSkills" : "Identify challenges; Suggest solutions", "qualificationsBasic" : "5 years relevant experience, Expanded Access experience, Working knowledge of Pharmacovigilance, Bachelor's or Master's degree, Experience with clients/external stakeholders, Reside within EST or CST time zones", "qualificationsPreferred" : "Knowledge of additional languages", "remoteFriendly" : true, "workSiteFlexibility" : "Remote", "rawDescription" : "About myTomorrows myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options. We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and BioPharma – connecting key stakeholders in the drug development ecosystem. We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection. With a global footprint spanning 134 countries, to date we’ve supported over 17,000 patients, 3,000 physicians and 350 sites, earning the trust of 60+ BioPharma companies. In October 2025, we closed a €25M investment with Avego Healthcare Capital to fuel our global ambitions and scale the business. Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today. The opportunity: Regulatory Affairs & Pharmacovigilance Manager As the Regulatory Affairs and Pharmacovigilance Manager, you will be responsible for ensuring compliance of our processes with country-specific expanded access regulations globally. In this role, you'll be a key contributor to our regulatory and quality infrastructure, keeping us aligned with global legislation. You will be actively working together with Medical Affairs, Program Management, Quality Assurance, and Supply Chain and will report to the Director of Regulatory Affairs and Pharmacovigilance (Emily says hi). Geographic Requirement: For candidates in North America, to ensure seamless collaboration with our teams, applicants must reside within the EST or CST time zones. What you will do in this role: - Support the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs. - Act as the Regulatory Affairs and Pharmacovigilance expert for communications with clients (pharmaceutical companies) and submissions to Health Authorities, as well as cross-functional meetings and audits. - Prepare, compile, and submit regulatory dossiers for cohort and named patient Expanded Access Programs (EAPs) on behalf of clients. - Provide input and support for the regulatory strategy for setting up and executing EAPs (e.g., where, when, and how). - Collaborate with the Commercial team to support new EAPs. - Ensure timely and compliant handling of all regulatory and pharmacovigilance activities related to EAPs. - Stay up to date on relevant global laws, regulations, and guidelines impacting EAPs. - Assist in drafting, reviewing, and maintaining regulatory documentation and templates. - Liaise with the Pharmacovigilance service provider to ensure alignment and compliance. - Contribute to maintaining department documentation such as SOPs (Standard Operating Procedures), QIs (Quality Incidents), and CAPAs (Corrective and Preventive Actions). What you bring to the table: - Approximately 5 years of relevant experience in Regulatory Affairs, including experience in Expanded Access. - Working knowledge of fundamental principles of Pharmacovigilance is required. - Solid understanding of national and international legislation and regulation relating to Expanded Access - A Bachelor’s or Master's degree in Life Sciences or a related field - Experience working directly with clients or external stakeholders in a professional setting - Strong communication skills (written and verbal) in English; able to convey complex topics clearly to both internal teams and external parties. Knowledge of additional languages is a plus - Comfortable collaborating across teams and working in a cross-functional environment - Proactive problem solver with the ability to identify potential regulatory or operational challenges early and suggest practical solutions - Familiarity with Microsoft 365 tools (e.g., Word, Excel, Teams, SharePoint) What we offer: - Impactful work that helps patients gain access to potentially lifesaving treatments. - International work environment, scale-up energy and flat organizational structure which encourages creativity and accountability. - Competitive salary, annual performance bonus and an Employee Stock Option Plan. - Great career development opportunities in a fast-growing company. - Learning and development budget alongside internal knowledge sharing sessions. - Hybrid working model if you're in the Netherlands. - Policies to support working parents. - Healthy lunch at the thriving Amsterdam office. - Unlimited access to professional guidance by certified psychologists via OpenUp - Enjoy monthly events hosted by our vibrant Culture Club as well as an annual ‘myTomorrowland’ company-wide celebration! Equal opportunities myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated. The best work comes from our best selves, and we go to great lengths in supporting our team members to be just that. ", "summaryDescription" : "Regulatory Affairs Pharmacovigilance Manager at myTomorrows. Skills: Regulatory Affairs, Pharmacovigilance, Expanded Access. Support regulatory strategies for EAPs. Act as RA/PV expert", "postedDate" : "2026-06-11T16:28:23.449", "createdAt" : "2026-06-11T16:28:23.449", "lastUpdated" : "2026-06-12T21:09:59.500", "ingestTimestamp" : "2026-06-11T16:28:23.449", "mongoId" : "6a2a7bcf74d8ee00a06646d5", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 150000, "salaryAnnualMax" : 210000, "salaryBand" : "150k-200k", "hasSalary" : true, "allSkills" : [ "Regulatory submissions", "Dossier preparation", "Regulatory documentation", "Problem solver", "Regulatory Affairs", "Pharmacovigilance", "Expanded Access", "Regulatory strategy", "Regulatory affairs", "Expanded Access Programs", "Expanded Access Regulations", "Biologicals", "Cell therapies", "Synthetic drugs", "National legislation", "International legislation", "Microsoft 365", "Word", "Excel", "Teams", "SharePoint" ], "skillCount" : 21, "jobCategory" : "operations", "jobSubcategory" : "regulatory-affairs-and-pharmacovigilance-management", "dataQualityScore" : 1.0, "daysOld" : 1, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Healthcare" }, { "id" : "6a2ca45e74d8ee00a09b17bc", "title" : "Medical Affairs Assistant", "company" : "OGT", "industry" : "Biotech", "salary" : { "min" : 27500.0, "max" : 35000.0, "currency" : "GBP", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "The estimation is based on the UK market baseline for an entry-level Medical Affairs Assistant in the Biotech industry in Cambridge, adjusted for seniority and company size." }, "location" : "418 Cambridge Science Park Milton Road Cambridge Cambridgeshire CB4 0PZ", "locations" : [ "418 Cambridge Science Park Milton Road Cambridge Cambridgeshire CB4 0PZ" ], "timestamp" : "2026-06-16T03:35:15.488", "fingerprint" : "4b73b79a1c7904fe5683fc94bc84a6e124d96a38f8ced98ae83ed1edac0e4dfc", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.eu.greenhouse.io/ogt/jobs/4862782101", "externalId" : "4862782101", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Cambridge", "state" : "Cambridgeshire", "country" : "United Kingdom", "continent" : "eu", "source" : "llm", "workMode" : "onsite", "geo" : "52.1975846,0.1391537" } ], "locationText" : "Cambridge, Cambridgeshire, United Kingdom", "employmentType" : "CONTRACT", "minimumEducation" : "Bachelor's", "technicalSkills" : "FISH processing", "professionalSkills" : [ "Good document practice" ], "hardSkillsList" : [ "Biological sample culturing", "Cell slide preparation", "FFPE tissue sectioning", "Image capture" ], "hardSkills" : [ { "name" : "Biological sample culturing", "level" : "intermediate" }, { "name" : "Cell slide preparation", "level" : "intermediate" }, { "name" : "FFPE tissue sectioning", "level" : "intermediate" }, { "name" : "Image capture", "level" : "intermediate" } ], "majorSkills" : "FISH processing, Laboratory management", "majorSkillsList" : [ "FISH processing", "Laboratory management" ], "coreResponsibilities" : "Ensure laboratory running, Process FISH workload, Use FFPE specimens, Use haematological specimens, Use prenatal specimens, Sample receipt, Sample release, Sample shipment, Sample storage, Sample disposal, Perform laboratory duties, Culture biological samples, Harvest biological samples, Prepare fixed cell slides, Section FFPE tissue blocks, Prepare FFPE slides, Maintain laboratory records, Maintain LIMS, Perform image capture, Support quality management, Comply with quality systems, Comply with regulations, Comply with safety procedures", "teamCollaboration" : "Medical Affairs team", "domainKnowledge" : "Human Tissue Act; ISO 9001:2015; ISO 13485:2016; ISO 27001:2022; IVDR; GCLP", "domainList" : [ "human-tissue-act", "iso-9001-2015", "iso-13485-2016", "iso-27001-2022", "ivdr", "gclp" ], "domainSpecificKnowledge" : [ "Human Tissue Act", "ISO 9001:2015", "ISO 13485:2016", "ISO 27001:2022", "IVDR", "GCLP" ], "toolProficiency" : [ "LIMS" ], "communicationSkills" : "Written communication; Verbal communication", "documentationSkills" : "Maintain laboratory records; Maintain LIMS", "qualificationsBasic" : "Bachelor's degree, 1 year laboratory experience, Basic FISH processing knowledge, High accuracy, Attention to detail, Work independently on routine tasks, Work accurately and efficiently, Work in high-volume environment, Work in process-driven environment, Work in protocol-driven environment, Written communication skills, Verbal communication skills", "qualificationsPreferred" : "Previous FISH experience, Microscopy experience, Microtomy experience, Cell culture techniques experience, LIMS knowledge, Experience with defined protocols, Experience with SOPs", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation of precision medicines. ** This position is a fixed-term contract, ending in December 2028 ** An opportunity has arisen in our Medical Affairs team for a Medical Affairs Assistant. This role offers a great blend of laboratory and administrative work, supporting FISH processing activities. What you’ll be doing for us: Ensure smooth and efficient running of the laboratory, including consumables, reagents, microscopes, equipment and software within the MA team Process FISH workload, using FFPE, haematological and prenatal specimens to support QC and studies in the medical affairs team Responsible for sample receipt, release, shipment, storage and disposal following standard operating procedures (SOPs) and adhering to the Human Tissue Act (2004) Laboratory duties such as biological sample culturing, harvesting, and fixed cell slide preparation Sectioning of FFPE tissue blocks and FFPE slide preparation Maintain laboratory records and LIMS, making sure they are up to date and accurate Perform image capture of FISH slides using automation or manual methods Support with maintaining appropriate proportion of the quality management system, including procedures and audits To comply with all site quality management systems, regulations and health and safety procedures (ISO 9001:2015, ISO 13485:2016, ISO 27001:2022, (EU) 2017/746 (IVDR), GCLP and Human Tissue Act (2004)) To complete any other tasks as commensurate with the level and nature of the post as delegated by the line manager. What we are looking for in you Essential A bachelor’s degree in molecular biology, biochemistry, genetics, biotechnology, or similar subject OR a minimum of one year laboratory experience Basic knowledge of FISH processing Good document practice High accuracy and attention to detail Ability to work independently on routine tasks, while knowing when to seek support Able to work accurately and efficiently in a high-volume, process-driven, and protocol-driven environment Strong Communication skills, both written and verbal. Desirable Previous experience with FISH Experience with microscopy and microtomy Experience in cell culture techniques Knowledge and previous use of a LIMS Familiarity with working to defined protocols or standard operating procedures (SOPs). In return you will receive: Competitive salary Pension Scheme (10% non-contributory) Private Health Insurance Private Dental Insurance Group Income Protection Group Life Assurance 25 days holiday plus UK bank holidays High Street Discount Scheme. Application is via CV and a one-page covering letter outlining your suitability for the role, salary expectations and notice period. Please note that we will need to establish your right to work during the recruitment process.", "summaryDescription" : "Medical Affairs Assistant at OGT. Skills: FISH processing, Laboratory management. Ensure laboratory running. Process FISH workload", "postedDate" : "2026-06-14T21:48:32.537", "createdAt" : "2026-06-14T21:48:32.537", "lastUpdated" : "2026-06-16T03:35:15.488", "ingestTimestamp" : "2026-06-14T21:48:32.537", "mongoId" : "6a2ca45e74d8ee00a09b17bc", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "<30k", "hasSalary" : false, "allSkills" : [ "Biological sample culturing", "Cell slide preparation", "FFPE tissue sectioning", "Image capture", "FISH processing", "Laboratory management", "Good document practice", "Human Tissue Act", "ISO 9001:2015", "ISO 13485:2016", "ISO 27001:2022", "IVDR", "GCLP", "LIMS" ], "skillCount" : 14, "jobCategory" : "engineering", "jobSubcategory" : "software", "seniorityLevel" : "Entry", "dataQualityScore" : 0.8888889, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Biotech", "llmIndustryConfidence" : 0.95 }, { "id" : "6a305085f292fd229cef15ed", "title" : "Head of Policy and Regulatory Affairs – US", "company" : "Elliptic", "industry" : "Marketing", "salary" : { "min" : 155000.0, "max" : 290000.0, "currency" : "USD", "frequency" : "Yearly" }, "location" : "New York, United States", "locations" : [ "New York, United States", "Washington Office" ], "certifications" : [ "CAMS", "CFA", "FRM" ], "timestamp" : "2026-06-16T11:04:28.417", "fingerprint" : "763481b0e8af17ce68191c15a68a45fc67bb4d6f45788e43e1546aa53e9662df", "source" : "ashby", "language" : "en", "applyUrl" : "https://jobs.ashbyhq.com/elliptic/b8d9dab4-3af9-453d-bd87-29e1ab710e2b/application", "externalId" : "b8d9dab4-3af9-453d-bd87-29e1ab710e2b", "industryFunction" : { }, "structuredLocations" : [ { "city" : "New York", "state" : "New York", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "40.7127281,-74.0060152" } ], "locationText" : "New York, New York, United States", "employmentType" : "FULL_TIME", "experienceMinYears" : 10, "experienceMaxYears" : 99, "experienceLevel" : "Executive", "professionalSkills" : [ "Public policy", "Regulatory engagement", "Government affairs", "Policy advocacy", "Thought leadership", "Client advisory", "Product development", "Client success", "Compliance strategy", "Risk mitigation", "Strategic relationships", "Industry analysis" ], "hardSkillsList" : [ "Regulatory analysis", "Policy analysis", "AML/CFT requirements", "Digital asset classification", "Blockchain analytics", "Crypto asset compliance" ], "softSkillsList" : [ "Leadership" ], "hardSkills" : [ { "name" : "Regulatory analysis", "level" : "intermediate" }, { "name" : "Policy analysis", "level" : "intermediate" }, { "name" : "AML/CFT requirements", "level" : "intermediate" }, { "name" : "Digital asset classification", "level" : "intermediate" }, { "name" : "Blockchain analytics", "level" : "intermediate" }, { "name" : "Crypto asset compliance", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Leadership" } ], "majorSkills" : "Digital Assets, Government Engagement, Financial Crime Prevention", "majorSkillsList" : [ "Digital Assets", "Government Engagement", "Financial Crime Prevention" ], "coreResponsibilities" : "Lead public policy engagement strategy, Lead regulatory engagement strategy, Engage with federal regulators, Engage with state regulators, Engage with policymakers, Engage with Congressional offices, Engage with international standard setters, Shape regulatory outcomes, Respond to policy frameworks, Respond to stablecoin legislation, Respond to AML/CFT requirements, Respond to digital asset classification, Strengthen regulatory voice, Strengthen thought leadership, Create authoritative content, Prepare Congressional testimony, Represent Elliptic externally, Advise internal teams, Empower internal teams, Provide regulatory insights, Provide regulatory analysis, Drive product development, Drive client success, Drive compliance strategy, Position Elliptic as partner, Serve as subject matter expert, Provide strategic advisory services, Build and maintain relationships, Represent Elliptic at conferences, Represent Elliptic at forums, Represent Elliptic at briefings, Represent Elliptic at meetings", "teamCollaboration" : "Global cross-functional team; Strategic Advisory team; Federal agencies; Congressional committees; State regulators; Industry associations; Financial institutions; Crypto native businesses; Government agencies; Financial authorities; Congressional staff; Policy communities", "domainKnowledge" : "Digital assets; Blockchain technology; Cryptocurrency; Financial crime prevention; Money laundering; Stablecoin legislation; FinCEN guidance; SEC jurisdiction; CFTC jurisdiction; State-level licensing; Federal frameworks; Key state regimes; NY BitLicense; State MTL frameworks; Digital asset economy", "domainList" : [ "digital-assets", "blockchain-technology", "cryptocurrency", "financial-crime-prevention", "money-laundering", "stablecoin-legislation", "fincen-guidance", "sec-jurisdiction", "cftc-jurisdiction", "state-level-licensing", "federal-frameworks", "key-state-regimes", "ny-bitlicense", "state-mtl-frameworks", "digital-asset-economy" ], "domainSpecificKnowledge" : [ "Digital assets", "Blockchain technology", "Cryptocurrency", "Financial crime prevention", "Money laundering", "Stablecoin legislation", "FinCEN guidance", "SEC jurisdiction", "CFTC jurisdiction", "State-level licensing", "Federal frameworks", "Key state regimes", "NY BitLicense", "State MTL frameworks", "Digital asset economy" ], "communicationSkills" : "Policy positions; Briefings; Public commentary; External representation; Executive meetings", "documentationSkills" : "Policy analysis; Regulatory updates; Congressional testimony preparation; Industry trend reports", "outcomesObjectives" : "Shape and respond to policy frameworks; Strengthen regulatory voice; Strengthen thought leadership; Drive product development; Drive client success; Drive compliance strategy; Position Elliptic as leading partner; Build trust in digital assets", "qualificationsBasic" : "5+ years experience in policy and regulatory affairs, Experience in US policy and regulatory engagement, Experience with federal and state regulators, Experience with Congressional offices, Experience with public sector stakeholders, Experience with crypto regulation, Experience with financial crime prevention, Experience with digital innovation, Experience with digital asset economy, Experience with FinCEN, Experience with SEC, Experience with CFTC, Experience with OCC, Experience with OFAC, Experience with state regulators, Experience with industry associations, Experience with blockchain technology, Experience with digital assets, Experience with regulatory compliance, Experience with government engagement, Experience with policy analysis, Experience with regulatory updates, Experience with industry trend reports, Experience with strategic relationships, Experience with federal agencies, Experience with Congressional committees, Experience with state-level regimes, Experience with NY BitLicense, Experience with state MTL frameworks, Experience working with federal agencies, Experience working with Congressional offices, Experience working with regulatory bodies, Experience working with intergovernmental institutions, Experience crafting policy positions, Experience crafting public commentary, Experience influencing regulatory outcomes, Experience with advocacy, Experience with collaborative engagement", "qualificationsPreferred" : "Former experience in federal regulatory body, Former experience in Congressional committee staff, Former experience in Treasury/FinCEN, Experience with stablecoins, Previous consulting experience, Previous advisory experience, Technical understanding of blockchain technology, Technical understanding of digital asset infrastructure, Experience developing training sessions, Experience delivering training sessions, Experience with international standard-setting bodies, Experience with FATF, Experience with Basel Committee", "remoteFriendly" : true, "workSiteFlexibility" : "Flexible", "rawDescription" : "At Elliptic, we believe cryptocurrency will play a huge role in the future of value transfer, and we care deeply about helping to build this future. In order for cryptocurrency to flourish, it’s important to prevent criminal abuse of the technology. Elliptic is the global leader in detecting, preventing, and pursuing criminal activity in cryptocurrencies. Our clients include the world’s leading cryptocurrency exchanges, financial institutions and government agencies. Our unique platform gives us an unparalleled understanding of cryptocurrency capital flows, using a combination of network science and machine learning to aggregate and interpret vast quantities of transaction data. We provide anti-money laundering (AML) compliance software and investigative services to the leading participants in the cryptocurrency ecosystem. Customers rely on us to analyse more than $150bn of their transactions every month, and include cryptocurrency businesses, major financial institutions, and federal government agencies. The company has a presence in London, UK, New York City, Singapore and Tokyo. We are backed by SBI Group, Albion VC, Octopus Ventures, SignalFire, Paladin Capital, Santander InnoVentures, and Digital Currency Group. Are you passionate, enthusiastic, and looking for an opportunity to grow your career in sales? Are you looking for your next challenge in an emerging and exciting market? If yes then we want to hear from you! The Impact You Will Have As Head of Policy and Regulatory Affairs – US, you will lead Elliptic’s public policy and regulatory engagement strategy across the United States, the most consequential jurisdiction shaping the future of digital assets. Based in Washington D.C. or New York, you will be Elliptic’s most senior voice on policy issues across the Americas, guiding our approach to engaging with federal and state regulators, policymakers, Congressional offices, and international standard setters. You will help shape regulatory outcomes across the evolving US landscape, including the Clarity Act, stablecoin frameworks, FinCEN guidance, SEC and CFTC jurisdiction, and state-level licensing regimes, while ensuring our strategy aligns with the rapidly evolving landscape of crypto regulation, financial crime prevention, and digital innovation. You will join a global, cross-functional team of regulatory specialists and subject matter experts, working at the forefront of engagement with governments, regulators, financial institutions, and crypto native businesses. In this commercially oriented role, you’ll act as a trusted advisor to existing and prospective clients, helping them navigate regulatory complexity, adopt Elliptic’s solutions with confidence, and meet their compliance objectives. Your policy insights will influence go-to-market strategies, support business development, and directly drive customer success, product-market fit, and revenue growth across the Americas. Your leadership will be instrumental in establishing Elliptic as the most trusted advisor for regulated institutions and public agencies seeking to understand and mitigate risks in the digital asset economy. Key Outcomes - Lead Elliptic’s strategic engagement with federal and state regulators, Congressional offices, and public sector stakeholders across the United States - Shape and respond to emerging crypto and digital asset policy frameworks, including stablecoin legislation, AML/CFT requirements, and digital asset classification - Strengthen Elliptic’s regulatory voice and thought leadership through policy advocacy, content creation, testimony preparation, and external representation - Advise and empower internal teams with regulatory insights and analysis to drive product development, client success, and compliance strategy - Position Elliptic as the leading technology partner for US government agencies and financial institutions building trust in digital assets What You Will Do - Serve as the primary subject matter expert on US policy, regulation, and government affairs related to digital assets and blockchain technology - Provide strategic advisory services to internal teams and external clients on regulatory compliance and government engagement - Develop thought leadership through authoritative content creation, including policy analysis, regulatory updates, Congressional testimony preparation, and industry trend reports - Work with our Strategic Advisory team to build and maintain strategic relationships with key stakeholders across federal agencies (FinCEN, SEC, CFTC, OCC, OFAC), Congressional committees, state regulators, and industry associations - Represent Elliptic at industry conferences, regulatory forums, Congressional briefings, and executive meetings with senior government and financial services leaders - Collaborate with product and engineering teams to provide expert guidance on regulatory requirements and institutional client needs - Advise on regulatory developments and market trends affecting digital asset policy and institutional adoption strategies - Support business development and enterprise sales processes with deep policy expertise and government relationship leverage - Contribute to cross-functional initiatives that accelerate responsible adoption of digital asset solutions within government and traditional finance - Build and maintain your professional profile through speaking engagements, media commentary, social media presence, and industry networking What You Will Achieve in the First 6 Months - Supported early customer engagements that demonstrate Elliptic’s regulatory expertise and strengthen confidence in our brand, and have been cited as a key expert resource by top prospects and customers - Delivered consistent, high-quality intelligence and policy insights to global stakeholders internally and externally - Established Elliptic as a credible and proactive voice in the US regulatory community - Work with our Strategic Advisory team to build upon our trusted relationships with at key regulators, Congressional offices, or (e.g., FinCEN, Treasury,) - Contributed visible US thought leadership content (publication, panel, consultation, or testimony) tied to Elliptic’s mission - Embedded the US as a critical contributor within the global Regulatory & Industry Affairs framework You Will Be a Great Fit Here If You - 10+ years of experience in regulatory affairs, public policy, government relations, or compliance, with a focus on financial services, digital assets, or public sector engagement - Deep understanding of the US digital asset regulatory landscape, including federal frameworks (SEC, CFTC, FinCEN, OCC, OFAC) and key state-level regimes (e.g., NY BitLicense, state MTL frameworks) - Experience working within or alongside federal agencies, Congressional offices, regulatory bodies, or intergovernmental institutions - Strong existing public-sector network across US financial authorities, Congressional staff, and policy communities - Exceptional communication skills, with experience crafting policy positions, briefings, and public commentary on complex legal and regulatory topics - Comfort working at the intersection of technology, law, and finance, including the regulatory applications of blockchain analytics and crypto asset compliance - Proven record of influencing regulatory outcomes through advocacy and collaborative engagement with policymakers and institutions - Passion for shaping the future of responsible crypto innovation, financial integrity, and regulatory clarity Bonus Points For - Former experience in a federal regulatory body, Congressional committee staff, or Treasury/FinCEN - Experience with stablecoins and their role in traditional finance and payments - Previous consulting or advisory experience in financial services or government affairs - Technical understanding of blockchain technology and digital asset infrastructure - Experience developing and delivering training and knowledge-sharing sessions - Experience working with international standard-setting bodies (FATF, Basel Committee) - Advanced degree in law, public policy, finance, economics, or related field - Professional qualifications in compliance or related fields (CAMS, CFA, FRM, etc.) - Experience in fintech, digital asset advisory, or crypto policy advocacy roles We know Diversity and Inclusion is much deeper than just hiring, but it is important for us to mention it here. We welcome and embrace individuals of all backgrounds and identities at Elliptic, and this is an ongoing priority for us.", "summaryDescription" : "Head of Policy and Regulatory Affairs – US at Elliptic. Skills: Digital Assets, Government Engagement, Financial Crime Prevention. Lead public policy engagement strategy. 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Cross-functional teams", "projectManagementSkills" : [ "Program management" ], "domainKnowledge" : "Medical device software regulations; EU MDR; QSR; ISO standards; EN standards", "domainList" : [ "medical-device-software-regulations", "eu-mdr", "qsr", "iso-standards", "en-standards" ], "domainSpecificKnowledge" : [ "Medical device software regulations", "EU MDR", "QSR", "ISO standards", "EN standards" ], "communicationSkills" : "Verbal communication; Written communication", "documentationSkills" : "Regulatory filings", "continuousLearning" : "Tuition reimbursement; Student debt program; Education benefit", "problemSolvingSkills" : "Problem-solving skills; Investigate and solve problems", "specialRequirements" : "10% travel", "qualificationsBasic" : "Bachelor's Degree in related field, Minimum 9 years related work experience", "qualificationsPreferred" : "Master's degree, Submission / registration types and requirements, Experience with Class III implantable devices, Experience managing and leading a team, Certification is a plus, Working knowledge of QSR, ISO, and EN standards, Working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies, Experience with medical device software requirements and software regulations", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. ## **JOB DESCRIPTION:** **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: * Career development with an international company where you can grow the career you dream of * Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. * An excellent retirement savings plan with high employer contribution * Tuition reimbursement, the [Freedom 2 Save](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree * A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune * A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists **The Opportunity** Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. We are recruiting for a **Senior** **Regulatory Affairs Manager** to join our team on-site in Alameda, CA. In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation. Additionally, will be responsible for compiling regulatory submissions and ensure data is effectively presented for the registration of products worldwide. **What You’ll Work On** * Recruits, coaches and develops organizational talent. * Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. * Creates an entrepreneurial environment. * Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. * May manage and coach a team of regulatory employees. * Keeps the organization's vision and values at the forefront of decision making and action. * Demonstrates effective change leadership. * Builds strategic partnerships to further departmental and organizational objectives. * Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. * Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.). * Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives. * Develops, monitors and appropriately adjusts the annual budget for department(s). * Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives. * Assess proposed regulations and communicate new requirements to the organization. * Lead the RA process for Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input. * Assist with promotional content development and review for compliance before distribution. * Lead Regulatory Affairs Ad & Promo SOP development and review. **Required****Qualifications** * Bachelor’s Degree in a related field or an equivalent combination of education and experience * Minimum 9 years related work experience. * Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals. * Monitors costs of projects and of human and material resources within a department or unit. * Monitors company-wide indicators such as market share and profitability. * Monitors external environment in area of technical or professional responsibility. * Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups. * Facilitates others' participation in the continuous improvement program. * Investigates and solves problems that impact work processes and personnel within or across units or departments. * Develops and communicates a vision for the organizational unit assigned. **Preferred** **Qualifications** * Master’s degree * Submission / registration types and requirements * Experience working with Class III implantable devices. * Effective verbal and written communication with diverse audience and team. * Analytical thinking with good problem-solving skills. * Experience managing and leading a team. * Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). * Must be able to lead and manage multiple and competing priorities and manage programs. * Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies. * Experience with medical device software requirements and software regulations. * Ability to identify risk areas and escalate issues as appropriate. [**Apply Now**](https://www.jobs.abbott/us/en) **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:**[www.abbottbenefits.com](http://www.abbottbenefits.com/pages/candidate.aspx) Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at [www.abbott.com](http://www.abbott.com/), on Facebook at [www.facebook.com/Abbott](http://www.facebook.com/Abbott) and on Twitter @AbbottNews.Connect with us at [www.abbott.com](http://www.abbott.com/), on Facebook at [www.facebook.com/Abbott](http://www.facebook.com/Abbott) and on Twitter @AbbottNews and @AbbottGlobal. **The base pay for this position is** $130,700.00 – $261,300.00 In specific locations, the pay range may vary from the range posted. ## **JOB FAMILY:** Regulatory Operations ## **DIVISION:** LNGO Lingo ## **LOCATION:** United States > Alameda : 2601 Harbor Bay Parkway ## **ADDITIONAL LOCATIONS:** ## **WORK SHIFT:** Standard ## **TRAVEL:** Yes, 10 % of the Time ## **MEDICAL SURVEILLANCE:** No ## **SIGNIFICANT WORK ACTIVITIES:** Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf", "summaryDescription" : "Senior Manager, Regulatory Affairs at Abbott. Skills: Regulatory Affairs, Product registration, Compliance. Recruit, coach and develop talent. 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By connecting and optimizing customer-owned devices like smart thermostats, EV chargers, and batteries. EnergyHub enables a cleaner, more flexible, and more reliable grid. EnergyHub empowers utilities and their customers to create a clean, distributed energy future. We help consumers turn their smart thermostats, EVs, batteries, and other products into virtual power plants that keep the grid stable and enable higher penetration of solar and wind power. Role Overview: EnergyHub is seeking a motivated and analytically minded Regulatory Affairs Intern to support our policy and regulatory strategy work. This role offers hands-on experience at the intersection of clean energy policy, grid modernization, and technology. The intern will contribute to research, strategy development, and cross-functional information sharing that supports EnergyHub’s VPP business across the U. S. Key Project Areas 401(k) or other retirement programs; paid time off; company-paid holidays; equity; bonuses; or commissions. Interns are eligible for any benefits required by applicable state or local law, including paid sick leave in jurisdictions that mandate it (such as Colorado, Washington, California, and New York City). To apply, please submit your application here or go to EnergyHub.com/careers. Hourly Rate $24—$25 USD", "summaryDescription" : "Regulatory Affairs Intern at EnergyHub. Skills: Regulatory affairs, Clean energy policy. Support policy work. 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Program Management; Medical Affairs; Quality Assurance; Supply Chain", "projectManagementSkills" : [ "Program management" ], "domainKnowledge" : "Expanded Access Programs; Clinical trials; Real-World Data", "domainList" : [ "expanded-access-programs", "clinical-trials", "real-world-data" ], "domainSpecificKnowledge" : [ "Expanded Access Programs", "Clinical trials", "Real-World Data" ], "communicationSkills" : "Stakeholder management", "qualificationsBasic" : "Significant experience in Regulatory Affairs, Experience in pharma, biotech, or CRO, Proven experience managing multiple programs, Proven experience managing complex regulatory portfolios, Knowledge of global regulatory frameworks, Demonstrated leadership experience managing teams, Demonstrated experience developing talent", "remoteFriendly" : true, "rawDescription" : "About myTomorrows myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options. We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and BioPharma – connecting key stakeholders in the drug development ecosystem. We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection. With a global footprint spanning 134 countries, to date we’ve supported over 17,000 patients, 3,000 physicians and 350 sites, earning the trust of 60+ BioPharma companies. In October 2025, we closed a €25M investment with Avego Healthcare Capital to fuel our global ambitions and scale the business. Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today. THE OPPORTUNITY: REGULATORY AFFAIRS DIRECTOR As Regulatory Affairs Director, you will play a critical leadership role in translating our global regulatory strategy into execution across programs, regions, and service lines. You will oversee a portfolio of regulatory activities, ensuring high-quality, compliant, and timely delivery while leading and developing a team of Regulatory Affairs professionals. You’ll work closely with cross-functional teams and act as a senior point of contact for both internal stakeholders and external partners. This role sits at the intersection of strategy, delivery, and leadership, and is key to scaling our Regulatory Affairs capabilities globally. WHAT YOU'LL DO IN THIS ROLE: DRIVE REGULATORY STRATEGY EXECUTION - Translate company and RA/PV strategy into clear regulatory plans across programs and regions - Drive implementation across Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data initiatives OVERSEE PROGRAM AND PORTFOLIO DELIVERY - Oversee multiple regulatory programs simultaneously, ensuring delivery against timelines, quality standards, and client expectations - Identify and proactively manage cross-program risks, dependencies, and resource constraints LEAD AND DEVELOP THE TEAM - Lead, coach, and develop Regulatory Affairs Managers and senior team members - Set clear expectations and drive accountability for performance, quality, and delivery COLLABORATE CROSS-FUNCTIONALLY - Partner closely with Program Management, Medical Affairs, Quality Assurance, and Supply Chain - Ensure regulatory input is embedded into end-to-end program delivery DRIVE OPERATIONAL EXCELLENCE AND PERFORMANCE - Drive standardization, consistency, and scalability of regulatory processes - Identify improvement opportunities and implement data-driven solutions ENGAGE WITH CLIENTS AND STAKEHOLDERS - Act as a senior point of contact for clients on regulatory matters - Support client discussions, audits, and regulatory interactions with Health Authorities ENSURE QUALITY, COMPLIANCE, AND RISK MANAGEMENT - Ensure adherence to global regulatory requirements and internal processes - Support inspection readiness and audit preparedness WHAT YOU BRING TO THE TABLE: - Advanced degree in life sciences, pharmacy, or a related field - Significant experience in Regulatory Affairs within pharma, biotech, or CRO environments - Proven experience managing multiple programs and complex regulatory portfolios - Strong knowledge of global regulatory frameworks (EAP, clinical trials, or similar environments) - Demonstrated leadership experience managing teams and developing talent - Excellent stakeholder management and communication skills Equal opportunities myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated. 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Drive implementation across EAPs", "postedDate" : "2026-06-11T16:58:12.288", "createdAt" : "2026-06-11T16:58:12.288", "lastUpdated" : "2026-06-13T08:55:22.340", "ingestTimestamp" : "2026-06-11T16:58:12.288", "mongoId" : "6a2a7bcf74d8ee00a06646d4", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "100k-150k", "hasSalary" : false, "allSkills" : [ "Regulatory affairs", "Global regulatory frameworks", "EAP", "Clinical trials", "Real-world data", "Leadership", "Regulatory strategy", "Program delivery", "Portfolio management", "Risk management", "Quality assurance", "Client engagement", "Program management", "Expanded Access Programs", "Real-World Data" ], "skillCount" : 15, "jobCategory" : "operations", "jobSubcategory" : "regulatory-affairs-and-pharmacovigilance-management", "dataQualityScore" : 1.0, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Health Tech" }, { "id" : "6a2a612874d8ee00a0621415", "title" : "Regulatory Affairs Manager", "company" : "Abbott Diabetes Care", "industry" : "Healthcare", "salary" : { "min" : 215000.0, "max" : 310000.0, "currency" : "PLN", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Manager in Healthcare in Warsaw, Poland, adjusted for seniority and company size." }, "location" : "Poland", "locations" : [ "Poland" ], "timestamp" : "2026-06-13T02:26:07.157", "fingerprint" : "d04bcb262da2d7fe1cae0ea457f3e4ff83961eb2129f2551f468e81f3355f425", "source" : "workday", "language" : "en", "applyUrl" : "https://abbott.wd5.myworkdayjobs.com/abbottcareers/job/Poland---Warsaw/Regulatory-Affairs-Manager---Poland---Eastern-Europe--Abbott-Diabetes-Care_31152056", "externalId" : "31152056", "industryFunction" : { }, "locationPoint" : "51.9194,19.1451", "structuredLocations" : [ { "city" : "Warsaw", "country" : "Poland", "continent" : "eu", "source" : "llm", "workMode" : "onsite", "geo" : "52.2333742,21.0711489" } ], "locationText" : "Warsaw, Poland", "employmentType" : "FULL_TIME", "experienceLevel" : "Manager", "professionalSkills" : [ "Regulatory affairs", "Regulatory strategy", "Product lifecycle management", "Market access", "Government affairs" ], "hardSkillsList" : [ "Technical documentation", "Regulatory submissions", "Regulatory intelligence", "MDR/IVDR implementation", "Quality system compliance" ], "hardSkills" : [ { "name" : "Technical documentation", "level" : "intermediate" }, { "name" : "Regulatory submissions", "level" : "intermediate" }, { "name" : "Regulatory intelligence", "level" : "intermediate" }, { "name" : "MDR/IVDR implementation", "level" : "intermediate" }, { "name" : "Quality system compliance", "level" : "intermediate" } ], "majorSkills" : "Regulatory affairs, MDR/IVDR, CE-marking", "majorSkillsList" : [ "Regulatory affairs", "MDR/IVDR", "CE-marking" ], "coreResponsibilities" : "Lead regulatory activities for new product launches, Manage regulatory activities for product rollouts, Prepare technical documentation, Review technical documentation, Maintain technical documentation, Support in-country regulatory submissions, Support in-country notifications, Support in-country registrations, Support reimbursement processes, Support tender documentation, Provide regulatory guidance for marketing materials, Provide regulatory guidance for promotional activities, Monitor regulatory intelligence, Interpret regulatory intelligence, Communicate regulatory intelligence, Advise internal teams on MDR implementation, Advise internal teams on IVDR implementation, Advise internal teams on local regulatory support, Coordinate regulatory strategy for design changes, Coordinate regulatory strategy for labeling changes, Review documentation for changes, Interact with authorities on changes, Participate in internal audits, Participate in external audits, Ensure compliance with Quality System, Ensure compliance with ISO 13485, Ensure compliance with MDR, Ensure compliance with IVDR, Ensure compliance with local regulations, Build relationships with regulatory authorities, Maintain relationships with regulatory authorities, Build relationships with internal stakeholders, Maintain relationships with internal stakeholders, Contribute to projects improving quality system efficiency, Contribute to projects improving product quality", "teamCollaboration" : "Cross-functional teams; Global Regulatory; R&D; Quality; Market Access; Marketing; Sales; Government Affairs; Legal", "domainKnowledge" : "Medical Devices; In Vitro Diagnostics; MDR (EU 2017/745); IVDR; CE-marking process", "domainList" : [ "medical-devices", "in-vitro-diagnostics", "mdr-eu-2017-745", "ivdr", "ce-marking-process" ], "domainSpecificKnowledge" : [ "Medical Devices", "In Vitro Diagnostics", "MDR (EU 2017/745)", "IVDR", "CE-marking process" ], "communicationSkills" : "English; Polish", "documentationSkills" : "Technical documentation; CE-marking files", "specialRequirements" : "10% travel", "qualificationsBasic" : "Bachelor's degree in scientific discipline, Solid understanding of MDR requirements, Experience with CE-marking process, Experience with in-country regulatory activities in Poland, Experience with in-country regulatory activities in Eastern Europe/Russia, Proven ability to lead regulatory strategy, Excellent communication skills in English, Excellent communication skills in Polish", "qualificationsPreferred" : "Knowledge of IVD regulatory frameworks, Knowledge of Russian language", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "## **JOB DESCRIPTION:** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: * Career development with an international company where you can grow the career you dream of . * A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. * A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. **About the Role** This position works out of our **Poland, Warsaw location** in the Abbott Diabetes Care (ADC) Division. We are seeking a highly skilled **Regulatory Affairs Manager** to join Abbott Diabetes Care and lead regulatory activities across the **EMEAP region** , with a focus on Poland and Eastern European markets. In this role, you will drive regulatory strategy, ensure compliance with global and local requirements, and support the timely introduction and lifecycle management of innovative diabetes care products. You will collaborate closely with cross‑functional teams including Global Regulatory, R&D, Quality, Market Access, Marketing, Sales, Government Affairs, and Legal. This position is ideal for a proactive, detail‑oriented regulatory professional who thrives in a matrixed, international environment. **What You’ll Do** * Lead and manage regulatory activities for new product launches and rollouts across EMEAP * Prepare, review, and maintain high‑quality technical documentation, including CE‑marking files for medical devices and IVDs. * Support in‑country regulatory submissions, notifications, registrations, reimbursement processes, and tender documentation. * Provide regulatory guidance for marketing materials and promotional activities. * Monitor, interpret, and communicate regulatory intelligence for assigned countries. * Advise internal teams on MDR, IVDR, and local regulatory requirements; support implementation of new or updated regulations. * Coordinate regulatory strategy for design or labeling changes, including documentation review and authority interactions. * Participate in internal and external audits with regulatory impact. * Ensure compliance with Abbott’s Quality System, ISO 13485, MDR/IVDR, and local regulations. * Build and maintain strong relationships with regulatory authorities and internal stakeholders. * Contribute to projects improving quality system efficiency and product quality. **Required Qualifications** * Min. Bachelor’s degree in a scientific discipline. * Solid understanding of **MDR (EU 2017/745)** requirements, including the **CE‑marking process** , applicable regulatory frameworks to Medical Devices and ideally In Vitro Diagnostics (IVDs). * Experience with **in‑country regulatory activities** in Poland and at least one additional country in Eastern European markets / Russia * Proven ability to lead regulatory strategy for product launches, design changes, and labeling updates. * Strong organizational skills and ability to work effectively in a **matrixed, geographically diverse environment**. * Excellent communication skills in **English and Polish** (both required). (Knowledge of Russian will be an advantage) * Experience interacting with regulatory authorities and supporting cross‑functional teams (R&D, Quality, Market Access, Marketing, Sales). [**Apply Now**](https://www.jobs.abbott/) Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at [www.abbott.com](http://www.abbott.com/), on Facebook at [www.facebook.com/Abbott](http://www.facebook.com/Abbott) and on Twitter @AbbottNews and @AbbottGlobal. **The base pay for this position is** N/A In specific locations, the pay range may vary from the range posted. ## **JOB FAMILY:** Regulatory Operations ## **DIVISION:** ADC Diabetes Care ## **LOCATION:** Poland > Park Postepu : Building B ## **ADDITIONAL LOCATIONS:** ## **WORK SHIFT:** Standard ## **TRAVEL:** Yes, 10 % of the Time ## **MEDICAL SURVEILLANCE:** Not Applicable ## **SIGNIFICANT WORK ACTIVITIES:** Not Applicable", "summaryDescription" : "Regulatory Affairs Manager at Abbott Diabetes Care. Skills: Regulatory affairs, MDR/IVDR, CE-marking. 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Work with business, technical and operations teams; Work with Public Policy, Public Relations and Legal teams; Work with regulatory country leads; Work with Technical Program Managers; Coordinate across Amazon Leo's entities; Coordinate across Amazon at large", "domainKnowledge" : "Communications regulation; NGSO communications systems; Satellite orbital; Radio frequency spectrum; Export control laws; Export Administration Regulations", "domainList" : [ "communications-regulation", "ngso-communications-systems", "satellite-orbital", "radio-frequency-spectrum", "export-control-laws", "export-administration-regulations" ], "domainSpecificKnowledge" : [ "Communications regulation", "NGSO communications systems", "Satellite orbital", "Radio frequency spectrum", "Export control laws", "Export Administration Regulations" ], "communicationSkills" : "External point of contact; Advocacy; Communicate risks", "documentationSkills" : "Complex compliance filings; Regulatory filings", "problemSolvingSkills" : "Anticipate bottlenecks; Remove blockers", "specialRequirements" : "Subject to export control laws, Obtain export licenses or approvals", "outcomesObjectives" : "Deliver fast, affordable and reliable internet connectivity; Advance regulatory interests; Ensure scalability; Allow service; Benefit our customers", "qualificationsBasic" : "Bachelor's degree or above, Experience in public policy and advocacy", "qualificationsPreferred" : "12+ years of working directly with government officials and regulatory bodies experience", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "Amazon Leo is Amazon’s low Earth orbit (LEO) satellite network. Our mission is to deliver fast, affordable and reliable internet connectivity to customers beyond the reach of existing networks. From individual households to schools, hospitals, businesses, and government agencies, Amazon Leo will serve people and organizations operating in locations without reliable connectivity. The Senior Lead, Regulatory Affairs, APAC will be the external point of contact for Amazon Leo’s service compliance obligation deliverables in front of telecommunications regulators and other stakeholders in countries throughout the APAC region. This role will use their specific knowledge of communications regulation to advance Amazon Leo’s regulatory interests by coordinating complex compliance filings, maintaining effective lines-of-communication with relevant regulatory bodies and policy makers, and developing mechanisms to ensure scalability. This position may require access to information, technology, or hardware that is subject to export control laws and regulations, including the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR). Employment in this position is contingent upon obtaining any required export licenses or other approvals from the United States government. As such, the successful candidate must be eligible to obtain any necessary export licenses or approvals based on their nationality, citizenship, and any other factors considered by the applicable export control regulations. Key job responsibilities Key job responsibilities include: * Interface directly with regulators and policy makers in countries throughout the APAC region to drive Amazon Leo's compliance strategy and perform advocacy consistent with Amazon Leo’s priorities. * Develop and optimize mechanisms to ensure accurate and timely filing of complex Communications Service Provider (CSP) compliance filings. * Align with Regulatory, Compliance, Legal, Public Policy, and Global Expansions on strategy for CSP compliance matters. * Drive timely and accurate compliance filings related to regulatory obligations that arise as a result of Amazon Leo’s status as a CSP (e.g., revenue reporting, subscriber reports, outage reporting, customer complaints, etc.). * Coordinate across Amazon Leo's entities, and across Amazon at large, to address the unique nature of Amazon Leo's operating as a CSP. A day in the life You will be responsible for communicating with regulators and other stakeholders on regulatory compliance matters, shaping national, regional and international regulations affecting NGSO communications systems. You will define and lead the regulatory compliance agenda to allow service, and collaborate with trade associations, government agencies, multilateral organizations, and other operators to shape rules and regulations in the best interest of our customers. You will work with business, technical and operations teams, as well as with Public Policy, Public Relations and Legal teams, to enhance the overall regulatory compliance strategy in priority countries, and work closely with regulatory country leads, Technical Program Managers (TPMs), and other teams to ensure alignment on a country and regional basis. You will anticipate bottlenecks and communicate risks clearly to leaders, escalating effectively, removing blockers, and delivering results. About the team The Regulatory team enables and protects Amazon Leo’s use of radio frequency spectrum and satellite orbital worldwide, defining and leading the regulatory agenda to benefit our customers. We operate globally, engaging with international, regional/sub-regional regulatory organizations, regulatory authorities, and governments. We obtain and maintain the required ITU filings and licenses for Amazon Leo's operations, coordinate spectrum use with other operators, and shape/promote space safety and sustainability. We are responsible for the licensing of facilities and services, and advocate for rules and regulations in the best interest of our customers, working with governments, trade associations, and operators. We work with the design, operational, and business teams to promote alignment between business objectives, the Program of Record, and regulatory and compliance requirements for delivery of service. Basic Qualifications: - Bachelor's degree or above in a relevant discipline (e.g. Law, Political Science, Public Policy, Public Affairs, Economic Development) - Experience in relevant public policy and advocacy on payments and financial services issues Preferred Qualifications: - 12+ years of working directly with government officials and regulatory bodies experience Acknowledgement of country: In the spirit of reconciliation Amazon acknowledges the Traditional Custodians of country throughout Australia and their connections to land, sea and community. We pay our respect to their elders past and present and extend that respect to all Aboriginal and Torres Strait Islander peoples today. IDE statement: Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.", "summaryDescription" : "Senior Lead, Regulatory Affairs, APAC at Amazon Kuiper. Skills: Regulatory affairs, Compliance, APAC region, Telecommunications regulation. Interface directly with regulators. Perform advocacy consistent with priorities", "postedDate" : "2026-06-13T06:36:16.768", "createdAt" : "2026-06-13T06:36:16.768", "lastUpdated" : "2026-06-15T02:36:45.003", "ingestTimestamp" : "2026-06-13T06:36:16.768", "mongoId" : "693072a570f0b99d58ffb691", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "sourceUrl" : "https://account.amazon.com/jobs/3135613/apply", "salaryBand" : "200k+", "hasSalary" : false, "allSkills" : [ "Communications regulation", "Regulatory compliance", "Export control laws", "Export Administration Regulations", "Regulatory affairs", "Compliance", "APAC region", "Telecommunications regulation", "Compliance strategy", "Advocacy", "Public policy", "Regulatory filings", "NGSO communications systems", "Satellite orbital", "Radio frequency spectrum" ], "skillCount" : 15, "jobCategory" : "other", "dataQualityScore" : 1.0, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Telecommunications" }, { "id" : "6a2a5d7f74d8ee00a06192ae", "title" : "Associate, Regulatory Affairs", "company" : "ClinChoice", "industry" : "Healthcare", "salary" : { "min" : 4500000.0, "max" : 7500000.0, "currency" : "AMD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for Junior Regulatory Affairs Associate in Armenia, adjusted for the biotech industry." }, "location" : "Armenia", "locations" : [ "Armenia" ], "timestamp" : "2026-06-14T21:30:16.192", "fingerprint" : "3a7629cc490b7b7a32842926e3ba14c1575f4b32d1c2a4f2503118168e745418", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.eu.greenhouse.io/clinchoice/jobs/4890364101", "externalId" : "4890364101", "industryFunction" : { }, "structuredLocations" : [ { "country" : "Armenia", "continent" : "as", "workMode" : "onsite" } ], "locationText" : "Armenia", "minimumEducation" : "Bachelor's", "professionalSkills" : [ "Regulatory submission", "Product registration" ], "hardSkillsList" : [ "Regulatory affairs", "Product labeling" ], "softSkillsList" : [ "Teamwork" ], "hardSkills" : [ { "name" : "Regulatory affairs", "level" : "intermediate" }, { "name" : "Product labeling", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Teamwork" } ], "majorSkills" : "Regulatory affairs, Marketing authorization", "majorSkillsList" : [ "Regulatory affairs", "Marketing authorization" ], "coreResponsibilities" : "Support new application for marketing authorization, Support renewal of medicinal products, Support variation of medicinal products, Support medical devices submission, Support cosmetics submission, Support food supplements submission, Follow up on queries from HA, Publish registration applications, Submit registration applications, Coordinate activities for product registration, Ensure product registration information is accurate, Ensure product registration information is current, Support compilation of regulatory information, Support tracking of regulatory information, Support indexing of regulatory information, Support archival of regulatory information, Specify storage requirements for regulated products, Specify labelling requirements for regulated products, Specify packaging requirements for regulated products, Create product labels, Update product labels, Review product labels, Quality check product labels", "teamCollaboration" : "Excellent teamwork", "domainKnowledge" : "Medicinal products; Medical devices; Cosmetics; Food supplements; Health Authority queries", "domainList" : [ "medicinal-products", "medical-devices", "cosmetics", "food-supplements", "health-authority-queries" ], "domainSpecificKnowledge" : [ "Medicinal products", "Medical devices", "Cosmetics", "Food supplements", "Health Authority queries" ], "documentationSkills" : "Regulatory information archival", "continuousLearning" : "Full performance and development process; End of year reviews; Continuous training", "qualificationsBasic" : "Bachelor's Degree in Life Science", "qualificationsPreferred" : "Experience in the related field", "workSiteFlexibility" : "Flexible", "rawDescription" : "ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as an Associate, Regulatory Affairs on a permanent basis. Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! Main Job Tasks and Responsibilities: Support with new application for marketing authorization/renewal/variation of medicinal products, medical devices, cosmetics, food supplements for regulatory submission and follow-up closely on queries from HA through to approval Publishing and submission of products registration applications Coordination of activities ensuring product registration information is accurate and current Support compilation, tracking, indexing and archival of regulatory information Specifying storage, labelling and packaging requirements for regulated products Creation, update, review and quality check of product labels Education and Experience: Bachelor’s Degree in Life Science (Chemistry, Biology, Biomedical Engineering) Experience in the related field is a plus Fluency in English Ability to work under pressure to meet the deadlines Ability to get a challenge and perform excellent teamwork Our Benefits: Flexible Working Hours Full performance and development process with end of year reviews Team events and end of year party Employee satisfaction survey - your feedback is important for continuous improvement Health Insurance The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare! Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.", "summaryDescription" : "Associate, Regulatory Affairs at ClinChoice. Skills: Regulatory affairs, Marketing authorization. Support new application for marketing authorization. Support renewal of medicinal products", "postedDate" : "2026-06-11T21:19:12.696", "createdAt" : "2026-06-11T21:19:12.696", "lastUpdated" : "2026-06-14T21:30:16.192", "ingestTimestamp" : "2026-06-11T21:19:12.696", "mongoId" : "6a2a5d7f74d8ee00a06192ae", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "200k+", "hasSalary" : false, "allSkills" : [ "Regulatory affairs", "Product labeling", "Teamwork", "Marketing authorization", "Regulatory submission", "Product registration", "Medicinal products", "Medical devices", "Cosmetics", "Food supplements", "Health Authority queries" ], "skillCount" : 11, "jobCategory" : "other", "jobSubcategory" : "regulatory-affairs", "dataQualityScore" : 0.7777778, "daysOld" : 3, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Healthcare" }, { "id" : "6a306f87f292fd229cfe9c35", "title" : "Manager, Local Affairs", "company" : "LA28", "industry" : "Sports & Fitness", "salary" : { "min" : 88000.0, "max" : 115000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : false }, "location" : "Los Angeles, California, United States", "locations" : [ "Los Angeles", "California", "United States" ], "timestamp" : "2026-06-16T09:42:17.319", "fingerprint" : "6d7dd9330713d62d26eb1c137c7035b43658bc71d9442007fe58f40c6667734f", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.greenhouse.io/la2028/jobs/7757573003", "externalId" : "7757573003", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Los Angeles", "state" : "California", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "34.0536909,-118.2427660" } ], "locationText" : "Los Angeles, California, United States", "experienceLevel" : "Manager", "professionalSkills" : [ "Stakeholder engagement", "Relationship management", "Project execution", "Policy monitoring", "Public sector priorities" ], "hardSkillsList" : [ "Operational needs", "Games planning", "Games delivery" ], "softSkillsList" : [ "Sound judgment", "Adaptability", "Public service" ], "hardSkills" : [ { "name" : "Operational needs", "level" : "intermediate" }, { "name" : "Games planning", "level" : "intermediate" }, { "name" : "Games delivery", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Sound judgment" }, { "name" : "Adaptability" }, { "name" : "Public service" } ], "majorSkills" : "Local government affairs, Venue cities relations, Football cities relations", "majorSkillsList" : [ "Local government affairs", "Venue cities relations", "Football cities relations" ], "coreResponsibilities" : "Serve as point of contact for Venue and, Manage day-to-day relationships with elected offices, Manage relationships with executive leadership, Manage relationships with departmental partners, Advance LA28’s priorities through proactive communication, Advance LA28’s priorities through relationship management, Collaborate across internal teams, Facilitate coordinated engagement with local government partners, Maintain relational alignment, Ensure advancement of operational priorities, Support negotiation of legal agreements, Support implementation of legal agreements, Support negotiation of operational commitments, Support implementation of operational commitments, Support negotiation of Games-related deliverables, Support implementation of Games-related deliverables, Plan presentations at public forums, Plan presentations at events with government leaders, Facilitate presentations at public forums, Facilitate presentations at events with government leaders, Manage action items from stakeholder meetings, Manage follow-ups from stakeholder meetings, Synthesize stakeholder interests, Synthesize stakeholder concerns, Synthesize stakeholder sentiment, Drive execution of projects, Monitor policy developments, Monitor operational developments, Help drive LA28’s public sector priorities, Help drive LA28’s engagement strategies, Secure critical support for the Games, Identify and resolve issues impacting Games readiness, Coordinate cross-functional workstreams, Coordinate local government engagement, Report to Director of Venue Cities Relations", "teamCollaboration" : "Cross-functional workstreams; Internal teams; External partners", "projectManagementSkills" : [ "Project management", "Operational execution" ], "domainKnowledge" : "Olympic and Paralympic Games; Local government affairs; Venue Cities; Football Cities", "domainList" : [ "olympic-and-paralympic-games", "local-government-affairs", "venue-cities", "football-cities" ], "domainSpecificKnowledge" : [ "Olympic and Paralympic Games", "Local government affairs", "Venue Cities", "Football Cities" ], "communicationSkills" : "Written communication; Verbal communication; Briefings preparation; Materials preparation", "problemSolvingSkills" : "Problem-solving skills; Good judgment", "specialRequirements" : "Work on-site in Los Angeles, Attend meetings and events across Southern California, Work in an open floorplan, Work evenings, weekends, and holidays, Perform other duties as role evolves", "outcomesObjectives" : "Deliver a once-in-a-generation event", "qualificationsBasic" : "Undergraduate degree in public policy, political science, or related field or equivalent work experience, Ability to work on-site in Los Angeles, CA, Ability to attend in-person meetings and events across the Southern California region, Ability to work efficiently in an open cubicle environment, Ability to work evenings, weekends, and holidays", "qualificationsPreferred" : "Experience working across Southern California jurisdictions", "workSiteFlexibility" : "Onsite", "rawDescription" : "LA28 does not provide relocation assistance. LA28 is the independent, non-profit, privately funded organizing committee for the Los Angeles 2028 Olympic and Paralympic Games. We are on a singular mission to create an Olympic and Paralympic Games that celebrate all that this city and country have to offer, delivering an unparalleled experience for athletes, fans, partners and our community. The 2028 Games mark the return of the Summer Games to the U. S. for the first time in 32 years and Los Angeles’ third time hosting an Olympic Games and first time welcoming the Paralympic Games. This presents the unique and exciting opportunity to celebrate our legacy with the Games and push the Olympic and Paralympic Movements forward, writing a new chapter of Games history in Los Angeles. Putting on an Olympic and Paralympic Games is a team sport. To build a Games unlike any the world has seen before, we need the best team in place–a team full of diverse perspectives, experiences and expertise. We are guided by the following set of values and behaviors–optimism, integrity, excellence, inclusion, co-creation and boldness–and look forward to hearing about how your past experiences align with them. Manager, Local Affairs The Government Relations team builds and sustains LA28’s partnerships with elected and appointed officials at every level of government to ensure the successful delivery of the Olympic and Paralympic Games. The Manager, Local Affairs will play a pivotal role in advancing LA28’s relationships with Venue Cities and Football Cities across Southern California and the country, helping to strengthen coordination among government stakeholders and advance LA28’s local government affairs priorities. This role serves as a key point of contact for a portfolio of LA28 Venue Cities and Football Cities, coordinating with city executives, elected officials, city managers, and other municipal stakeholders to support Games planning and delivery. The Manager ensures local governments are informed, engaged, and aligned with LA28’s operational needs, while identifying and resolving issues that may impact Games readiness. Internally, the Manager coordinates cross-functional workstreams related to local government engagement, monitors policy and operational developments, and helps drive LA28’s public sector priorities and engagement strategies to secure critical support for the Games. Portfolio jurisdictions include: Anaheim, Arcadia, Carson, Inglewood, Long Beach, Oklahoma City, Pasadena, Pomona, City of Industry, San Diego, San Jose, St. Louis, Nashville, New York, and Columbus. The ideal candidate exercises sound judgment and is detail-oriented, proactive, and thrives in a fast-paced environment where organization, adaptability, and communication are key. They bring a passion for public service and a deep interest in the intersection of sports, government, and policy. This role reports to the Director of Venue Cities Relations and works closely with colleagues across LA28 and external partners to help deliver a once-in-a-generation event for Los Angeles and the world. Key Responsibilities: Stakeholder Engagement Serve as a trusted point of contact for Venue and Football Cities, managing day-to-day relationships with elected offices, executive leadership, and departmental partners, advancing LA28’s priorities through proactive communication and relationship management. Collaborate across internal teams to facilitate coordinated engagement with local government partners, maintaining relational alignment and ensuring the advancement of operational priorities. Support negotiation and implementation of legal agreements, operational commitments, and Games-related deliverables. Plan and facilitate presentations at public forums and events with government leaders, creating opportunities for meaningful collaboration and partnership. Manage action items and follow-ups from stakeholder meetings to ensure relational accountability. Synthesize stakeholder interests, concerns, and sentiment to inform engagement strategies. Project Management Drive the execution of State experience working across Southern California jurisdictions is preferred, though not required. Strong teamwork, interpersonal skills, and the ability to build trusted relationships with a wide range of external stakeholders. Excellent written and verbal communication skills, including experience preparing briefings and materials for senior leadership. Demonstrated ability to prioritize and perform under pressure, manage multiple workstreams, and deliver against tight deadlines. Highly organized and detail-oriented, with strong operational execution and project management skills. Strong problem-solving skills and ability to use good judgment and work independently, while also knowing when to seek feedback and buy-in. An enthusiastic, entrepreneurial spirit, and the ability to thrive in a fast-paced, evolving organizational environment. Commitment to understanding the stakeholder landscape, including political trends and its impact on LA28 initiatives. Ability to handle sensitive information with discretion and professionalism. Preferred Qualifications Experience managing relationships across multiple municipal jurisdictions or city partners. Familiarity with Southern California-area government and regional dynamics. Familiarity with government processes and public agency coordination for major events, with experience in the sporting and live events industries preferred. Proficiency in Microsoft Office Suite, including advanced Excel and PowerPoint skills; ability to quickly adapt to new tools and systems (e.g., CRM and project management platforms such as Smartsheet). Expectations: Innovative Approach – Ability to identify opportunities, develop new ideas and execute on creative concepts while managing to a budget.  Influencing Skills – Ability to drive organizational alignment through collaboration.  Flexible Approach – Ability to roll with the transitional nature of the organization as it grows and establishes itself over the next 2 years.  Challenger Mindset – Inclination to drive ongoing improvement in people and process.    Education/Training/Certifications An undergraduate degree in public policy, political science, or related field or equivalent work experience.  Physical Requirements and Working Conditions: Ability to work on-site in Los Angeles, CA and attend in-person meetings and events across the Southern California region. The majority of work will be conducted in an office setting, requiring extended periods of time using computers, phones, and other office equipment.    The LA28 office is an open floorplan working environment; employees must be able to work efficiently in an open cubicle environment.    Hours of work may vary, including evenings, weekends, and holidays, especially during peak event periods.  Perform other duties as required; the role will evolve over time and may include operational responsibilities during the Olympic and Paralympic Games.  The annual base salary range for this position is $88,000 - $115,000. The pay scale provided is the range that LA28 reasonably expects to pay as starting base compensation for this role. All LA28 compensation remains subject to final determination based on individual candidate qualifications, experience, or other reasonable criteria consistent with LA28’s operational business needs and applicable law. LA28 does not provide relocation assistance. LA28 is committed to fair and unbiased recruitment procedures allowing all applicants an equal opportunity for employment, free from discrimination on the basis of religion, race, sex, age, sexual orientation, disability, color, ethnic or national origin, or any other classification as may be protected by applicable law. LA28 will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring Ordinance and all applicable laws. We strive to build a team that is inclusive and encourage qualified candidates of all backgrounds, perspectives, and identities to apply. We assess applications based on relevant skills, education, and experience a candidate can add to our team.", "summaryDescription" : "Manager, Local Affairs at LA28. Skills: Local government affairs, Venue cities relations, Football cities relations. Serve as point of contact for Venue and. Manage day-to-day relationships with elected offices", "postedDate" : "2026-06-16T01:15:46.555", "createdAt" : "2026-06-16T01:15:46.555", "lastUpdated" : "2026-06-16T09:42:17.319", "ingestTimestamp" : "2026-06-16T01:15:46.555", "mongoId" : "6a306f87f292fd229cfe9c35", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 88000, "salaryAnnualMax" : 115000, "salaryBand" : "75k-100k", "hasSalary" : true, "allSkills" : [ "Operational needs", "Games planning", "Games delivery", "Sound judgment", "Adaptability", "Public service", "Local government affairs", "Venue cities relations", "Football cities relations", "Stakeholder engagement", "Relationship management", "Project execution", "Policy monitoring", "Public sector priorities", "Project management", "Operational execution", "Olympic and Paralympic Games", "Venue Cities", "Football Cities" ], "skillCount" : 19, "jobCategory" : "general", "jobSubcategory" : "general", "seniorityLevel" : "Manager", "dataQualityScore" : 0.8888889, "daysOld" : 0, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Government", "llmIndustryConfidence" : 0.9 }, { "id" : "6a305b2cf292fd229cf5a2f6", "title" : "Manager, Local Affairs", "company" : "LA28", "industry" : "Sports & Fitness", "salary" : { "min" : 88000.0, "max" : 115000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : false }, "location" : "Los Angeles, California, United States", "locations" : [ "Los Angeles", "California", "United States" ], "timestamp" : "2026-06-16T09:18:16.088", "fingerprint" : "5d7274f9b7a2f8b5556762b6de0ec1f2d6656aecf090e0690137d4a3dea19311", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.greenhouse.io/la28careers/jobs/7772344003", "externalId" : "7772344003", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Los Angeles", "state" : "California", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "34.0536909,-118.2427660" } ], "locationText" : "Los Angeles, California, United States", "experienceLevel" : "Manager", "professionalSkills" : [ "Project management", "Operational execution" ], "softSkillsList" : [ "Judgment", "Adaptability", "Organization" ], "softSkills" : [ { "name" : "Judgment" }, { "name" : "Adaptability" }, { "name" : "Organization" } ], "majorSkills" : "Local government affairs, Stakeholder engagement, Games delivery", "majorSkillsList" : [ "Local government affairs", "Stakeholder engagement", "Games delivery" ], "coreResponsibilities" : "Serve as point of contact for Venue and, Manage relationships with elected offices, executive leadership, and, Advance LA28’s priorities through proactive communication and relationship, Collaborate across internal teams for coordinated engagement with, Ensure advancement of operational priorities, Support negotiation and implementation of legal agreements, operational, Plan and facilitate presentations at public forums and, Create opportunities for meaningful collaboration and partnership, Manage action items and follow-ups from stakeholder meetings, Ensure relational accountability, Synthesize stakeholder interests, concerns, and sentiment to inform, Drive execution of projects and initiatives, Monitor policy and operational developments, Help drive LA28’s public sector priorities and engagement, Secure critical support for the Games", "teamCollaboration" : "Cross-functional workstreams; External partners", "domainKnowledge" : "Olympic and Paralympic Games; Local government affairs; Venue Cities Relations", "domainList" : [ "olympic-and-paralympic-games", "local-government-affairs", "venue-cities-relations" ], "domainSpecificKnowledge" : [ "Olympic and Paralympic Games", "Local government affairs", "Venue Cities Relations" ], "communicationSkills" : "Briefings; Materials for senior leadership", "problemSolvingSkills" : "Problem-solving", "specialRequirements" : "Work on-site in Los Angeles, CA, Attend in-person meetings and events across Southern California region, Work in an open cubicle environment, Work evenings, weekends, and holidays, Work during peak event periods", "qualificationsBasic" : "Undergraduate degree in public policy, political science, or related field or equivalent work experience", "qualificationsPreferred" : "Experience working across Southern California jurisdictions", "workSiteFlexibility" : "Onsite", "rawDescription" : "LA28 does not provide relocation assistance. LA28 is the independent, non-profit, privately funded organizing committee for the Los Angeles 2028 Olympic and Paralympic Games. We are on a singular mission to create an Olympic and Paralympic Games that celebrate all that this city and country have to offer, delivering an unparalleled experience for athletes, fans, partners and our community. The 2028 Games mark the return of the Summer Games to the U. S. for the first time in 32 years and Los Angeles’ third time hosting an Olympic Games and first time welcoming the Paralympic Games. This presents the unique and exciting opportunity to celebrate our legacy with the Games and push the Olympic and Paralympic Movements forward, writing a new chapter of Games history in Los Angeles. Putting on an Olympic and Paralympic Games is a team sport. To build a Games unlike any the world has seen before, we need the best team in place–a team full of diverse perspectives, experiences and expertise. We are guided by the following set of values and behaviors–optimism, integrity, excellence, inclusion, co-creation and boldness–and look forward to hearing about how your past experiences align with them. Manager, Local Affairs The Government Relations team builds and sustains LA28’s partnerships with elected and appointed officials at every level of government to ensure the successful delivery of the Olympic and Paralympic Games. The Manager, Local Affairs will play a pivotal role in advancing LA28’s relationships with Venue Cities and Football Cities across Southern California and the country, helping to strengthen coordination among government stakeholders and advance LA28’s local government affairs priorities. This role serves as a key point of contact for a portfolio of LA28 Venue Cities and Football Cities, coordinating with city executives, elected officials, city managers, and other municipal stakeholders to support Games planning and delivery. The Manager ensures local governments are informed, engaged, and aligned with LA28’s operational needs, while identifying and resolving issues that may impact Games readiness. Internally, the Manager coordinates cross-functional workstreams related to local government engagement, monitors policy and operational developments, and helps drive LA28’s public sector priorities and engagement strategies to secure critical support for the Games. Portfolio jurisdictions include: Anaheim, Arcadia, Carson, Inglewood, Long Beach, Oklahoma City, Pasadena, Pomona, City of Industry, San Diego, San Jose, St. Louis, Nashville, New York, and Columbus. The ideal candidate exercises sound judgment and is detail-oriented, proactive, and thrives in a fast-paced environment where organization, adaptability, and communication are key. They bring a passion for public service and a deep interest in the intersection of sports, government, and policy. This role reports to the Director of Venue Cities Relations and works closely with colleagues across LA28 and external partners to help deliver a once-in-a-generation event for Los Angeles and the world. Key Responsibilities: Stakeholder Engagement Serve as a trusted point of contact for Venue and Football Cities, managing day-to-day relationships with elected offices, executive leadership, and departmental partners, advancing LA28’s priorities through proactive communication and relationship management. Collaborate across internal teams to facilitate coordinated engagement with local government partners, maintaining relational alignment and ensuring the advancement of operational priorities. Support negotiation and implementation of legal agreements, operational commitments, and Games-related deliverables. Plan and facilitate presentations at public forums and events with government leaders, creating opportunities for meaningful collaboration and partnership. Manage action items and follow-ups from stakeholder meetings to ensure relational accountability. Synthesize stakeholder interests, concerns, and sentiment to inform engagement strategies. Project Management Drive the execution of State experience working across Southern California jurisdictions is preferred, though not required. Strong teamwork, interpersonal skills, and the ability to build trusted relationships with a wide range of external stakeholders. Excellent written and verbal communication skills, including experience preparing briefings and materials for senior leadership. Demonstrated ability to prioritize and perform under pressure, manage multiple workstreams, and deliver against tight deadlines. Highly organized and detail-oriented, with strong operational execution and project management skills. Strong problem-solving skills and ability to use good judgment and work independently, while also knowing when to seek feedback and buy-in. An enthusiastic, entrepreneurial spirit, and the ability to thrive in a fast-paced, evolving organizational environment. Commitment to understanding the stakeholder landscape, including political trends and its impact on LA28 initiatives. Ability to handle sensitive information with discretion and professionalism. Preferred Qualifications Experience managing relationships across multiple municipal jurisdictions or city partners. Familiarity with Southern California-area government and regional dynamics. Familiarity with government processes and public agency coordination for major events, with experience in the sporting and live events industries preferred. Proficiency in Microsoft Office Suite, including advanced Excel and PowerPoint skills; ability to quickly adapt to new tools and systems (e.g., CRM and project management platforms such as Smartsheet). Expectations: Innovative Approach – Ability to identify opportunities, develop new ideas and execute on creative concepts while managing to a budget.  Influencing Skills – Ability to drive organizational alignment through collaboration.  Flexible Approach – Ability to roll with the transitional nature of the organization as it grows and establishes itself over the next 2 years.  Challenger Mindset – Inclination to drive ongoing improvement in people and process.    Education/Training/Certifications An undergraduate degree in public policy, political science, or related field or equivalent work experience.  Physical Requirements and Working Conditions: Ability to work on-site in Los Angeles, CA and attend in-person meetings and events across the Southern California region. The majority of work will be conducted in an office setting, requiring extended periods of time using computers, phones, and other office equipment.    The LA28 office is an open floorplan working environment; employees must be able to work efficiently in an open cubicle environment.    Hours of work may vary, including evenings, weekends, and holidays, especially during peak event periods.  Perform other duties as required; the role will evolve over time and may include operational responsibilities during the Olympic and Paralympic Games.  The annual base salary range for this position is $88,000 - $115,000. The pay scale provided is the range that LA28 reasonably expects to pay as starting base compensation for this role. All LA28 compensation remains subject to final determination based on individual candidate qualifications, experience, or other reasonable criteria consistent with LA28’s operational business needs and applicable law. LA28 does not provide relocation assistance. LA28 is committed to fair and unbiased recruitment procedures allowing all applicants an equal opportunity for employment, free from discrimination on the basis of religion, race, sex, age, sexual orientation, disability, color, ethnic or national origin, or any other classification as may be protected by applicable law. LA28 will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring Ordinance and all applicable laws. We strive to build a team that is inclusive and encourage qualified candidates of all backgrounds, perspectives, and identities to apply. We assess applications based on relevant skills, education, and experience a candidate can add to our team.", "summaryDescription" : "Manager, Local Affairs at LA28. Skills: Local government affairs, Stakeholder engagement, Games delivery. Serve as point of contact for Venue and. 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Commercial team; Medical Affairs team; Legal team; Compliance team; Corporate Affairs team; Development team", "domainKnowledge" : "Biopharmaceutical industry; Neuroscience; Ion channel biology; FDA regulations; Prescription drug promotion", "domainList" : [ "biopharmaceutical-industry", "neuroscience", "ion-channel-biology", "fda-regulations", "prescription-drug-promotion" ], "domainSpecificKnowledge" : [ "Biopharmaceutical industry", "Neuroscience", "Ion channel biology", "FDA regulations", "Prescription drug promotion" ], "communicationSkills" : "Verbal communication; Written communication; Interpersonal communication; Listening skills; Clear communication; Concise communication", "documentationSkills" : "Regulatory filings", "continuousLearning" : "Training; Learning and Development program; Tuition Assistance program", "problemSolvingSkills" : "Effective problem-solving", "outcomesObjectives" : "Meet goals and objectives", "qualificationsBasic" : "Bachelor's degree, 10+ years experience, 8+ years Advertising Promotion, FDA laws regulations guidances, Manage complex matrixed environment", "qualificationsPreferred" : "Advanced degree preferred", "remoteFriendly" : false, "workSiteFlexibility" : "Hybrid", "rawDescription" : "Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE https://www.nasdaq.com/market-activity/stocks/xene) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. What We Do: We are advancing an exciting product pipeline https://xenon-pharma.com/pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are important pain targets. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations. About the Role: We are seeking a Director, Regulatory affairs, Commercial (Advertising & Promotion), to join our Regulatory Affairs team. The Director will be responsible for strategic regulatory advice and direction for marketed products and development compounds in alignment with the overarching regulatory and brand strategy. The Director will have oversight of day-to-day activities for their assigned role, department activities, and direct reports (if applicable) in order to meet goals and objectives. The Director will report to the VP of Commercial Regulatory Affairs. This position reports to the Vice President, Regulatory Affairs, Commercial and will be based out of Boston, MA, USA in our Needham office. This is a Hybrid position requiring a minimum of two onsite days per week. RESPONSIBILITIES: - Provide strategic regulatory advice, review, and decisions for product promotion, disease state education, pipeline, and Medical materials for alignment with applicable FDA regulations and guidance documents - Provide strategic regulatory support to the business by generating innovative solutions and effective problem-solving aligned with the company’s guiding principles in order to achieve desired outcomes - Develop and establish strong internal cross-functional relationships with the Commercial, Medical Affairs, Legal, Compliance, Corporate Affairs, and Development to foster open communication, collaboration, and teamwork - Continually monitors and evaluates the regulatory environment, interprets new regulations, guidance documents, enforcement activities and trends for potential impact on the business and company - Maintain in-depth understanding of clinical trial design and interpretation of clinical data and communicate complex issues clearly and concisely - Establishes and maintains a relationship with the Office of Prescription Drug Promotion (OPDP) at FDA - Provide appropriate oversight of promotional material review and ensure on-time and accurate submission of applicable materials to FDA - Assist with training employees at Xenon and in developing and improving process efficiencies - Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any - Other duties as assigned QUALIFICATIONS: - At minimum, a relevant four-year undergraduate degree; An advanced degree is preferred - 10+ years of experience in progressive Regulatory Affairs management positions in the biotech or pharmaceutical industry; A minimum of 8 years of experience focused on Regulatory Advertising and Promotion - Strong verbal and written communication skills; interpersonal and listening skills implemented in a positive and effective manner - Expertise in applicable FDA laws, regulations, guidances, and industry standards - Ability to manage a complex matrixed environment with multiple competing priorities and tasks appropriately and with autonomy - Strong communication, leadership and interpersonal skills required Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. 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Work with cross-functional teams or LRA’s for submission documents and verification of packages. Updating relevant submission tracker i. e. J tracker, HAQ tracker, PSMF tracker etc. Renewal support: Tracking of licenses for registration and approval. Tracking of approval validity of licenses and renewal timelines. Planning for renewal submission. Co-ordination with cross-functional team for Renewal documentation. Co-ordination with Local RA lead for Renewal documentation and submission. Preparation of Renewal package. Submission of Renewal to health authority and post submission activity. CFI support: Review and edit the consolidated CFI independently and with applying critical thinking and common sense Make sure that all the regulatory actions provided in the consolidated CFI fit for purpose (i. e. meet requirements of GVP module VII.B.5.1 to 4) and are written in such a way that it can be directly copied into the aggregate report Challenge LOC if their contribution is not appropriate Review the regulatory contribution in the draft and final aggregate report based on the outcome of the consolidated CFI Submit the PSUSA and follow until completion Submit the post PSUSA variations Experience/Qualifications: Minimum B. S. 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The AGC coordinates regulatory interactions and examinations for Jackson's insurance and distribution businesses; oversees regulatory filings and other regulatory submissions; facilitates remediation of exam findings; provides leadership with regulatory examinations and interactions; assists with highly confidential projects; assists with the development and implementation of corporate policies; and coordinates legal and compliance efforts related to artificial intelligence, data governance, privacy, and social media. ## **_Essential Responsibilities_** ## * Coordinates responses to regulatory inquiries and examination requests, including matters received from state, federal, and international regulators. Partners and collaborates with key stakeholders across Jackson’s actuarial, finance, operations, insurance, and distribution businesses to identify key regulatory issues impacting the Company. * Responsible for preparation and timely submission of regulatory filings, amendments, and other confidential regulatory communications associated with Jackson’s domestic and international regulatory obligations. * Prepares interpretive guidance and coordinates regulatory implementations as requested. * Supports the Government Relations department with federal and state advocacy by providing technical expertise, including provision of model legislative and regulatory language and contributing to position papers on legislative and regulatory issues. * Reviews the Company’s policies for compliance with applicable laws and regulations and industry best practices and, where necessary, creates policies and procedures where none exist or updates existing policies. * Assists in the implementation and management of remediating items identified by regulators as either formal findings or potential issues arising from exams or identified internally by the Jackson Chief Compliance Officer. * Identifies trends within the regulatory landscape that may impact Jackson, especially those arising from exams, enforcement actions, and other state guidance. * Provides regular reporting on examination and regulatory activity both within Jackson and the marketplace at large. * Researches and handles legal issues, prepares legal and risk analysis as requested by the AVP, Regulatory Affairs; Jackson Chief Compliance Officer; and Enterprise Chief Compliance Officer. ## **_Other Duties_** ## * Occasional business travel may be required. * Performs other duties and/or projects as assigned. ## **_Knowledge, Skills and Abilities_** ## * Exceptional project management skills. * Excellent organizational and prioritization skills. * Strong attention to detail, editing, and proofreading skills. * Demonstrated ability to work independently and collaboratively in a team environment. * Exceptional ability to make decisions while operating in a fast-paced and deadline-oriented environment. * Excellent verbal, written, and presentation skills with the ability to articulate important legal concerns/principles to business units. * Excellent research, analysis, and drafting skills. * Exceptional critical thinking and analytical reasoning skills with the ability to provide alternate approaches and solutions. * Strong working knowledge of Microsoft Office, including Word, Access, Excel, and Outlook. * Effective at establishing and maintaining positive working relationships with management, colleagues, and internal and external contacts. * Possession of a strong business acumen. * Demonstrated mentoring skills. * Solid working knowledge of the life insurance and annuity industry, including operations and products. * Solid working knowledge of the broker-dealer and insurance agency industry, including operations, securities products, and sales processes. * Strong knowledge of state insurance and federal securities laws, regulations, and standards. * Familiarity with the use of Lexis to conduct legal research. ## **_Qualifications_** * ## Juris Doctor from ABA accredited law school required. * ## Member in good standing of a State Bar Association required. * ## 8+ years of prior legal experience required. * ## 8+ years of insurance and/or financial securities experience preferred. Jackson is proud to be an equal opportunity workplace. The Company subscribes to and endorses federal and state laws and regulations relating to equal employment opportunity for all persons without regard to race, color, religion, gender, age, national origin, legally-recognized disability, marital status, legally-protected medical condition, citizenship, ancestry, height, weight, sexual orientation, veteran status, or any other factor not related to the needs of the job. The Company is committed to a policy of equal opportunity. 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Diverse stakeholder groups", "projectManagementSkills" : [ "Project delivery" ], "domainKnowledge" : "Regulatory requirements; Electronic document systems; Regulatory management systems; Marketing authorization applications; Electronic common technical documents; Document management standards; Quality requirements; Spinal implants; Navigation systems; Robotic guidance systems; Advanced imaging; Data-driven planning tools; Surgical procedures; Neurological conditions; Spinal conditions", "domainList" : [ "regulatory-requirements", "electronic-document-systems", "regulatory-management-systems", "marketing-authorization-applications", "electronic-common-technical-documents", "document-management-standards", "quality-requirements", "spinal-implants", "navigation-systems", "robotic-guidance-systems", "advanced-imaging", "data-driven-planning-tools", "surgical-procedures", "neurological-conditions", "spinal-conditions" ], "domainSpecificKnowledge" : [ "Regulatory requirements", "Electronic document systems", "Regulatory management systems", "Marketing authorization applications", "Electronic common technical documents", "Document management standards", "Quality requirements", "Spinal implants", "Navigation systems", "Robotic guidance systems", "Advanced imaging", "Data-driven planning tools", "Surgical procedures", "Neurological conditions", "Spinal conditions" ], "toolProficiency" : [ "Electronic publishing tools", "Electronic document systems" ], "communicationSkills" : "Report-outs to leadership", "documentationSkills" : "Regulatory documentation", "problemSolvingSkills" : "Troubleshooting", "specialRequirements" : "Minimum 4 days a week onsite", "outcomesObjectives" : "Support timely market access; Support ongoing compliance; Ensure work alignment with policies; Ensure work alignment with procedures; Ensure work alignment with quality standards; Enhance surgical precision; Streamline workflows; Support improved patient outcomes", "qualificationsBasic" : "Baccalaureate degree, 2 years of relevant experience", "qualificationsPreferred" : "Experience with regulatory data systems, Experience preparing regulatory submissions, Attention to detail, Organizational skills, Ability to manage multiple projects, Ability to meet deadlines, Effective written communication skills, Effective verbal communication skills", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "We anticipate the application window for this opening will close on - 20 Jun 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. # **A Day in the Life** Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes worldwide. Check us out on LinkedIn: [Medtronic CST](https://www.linkedin.com/company/medtronic-brain-and-spine-therapies/posts/?feedView=all) The Regulatory Affairs Specialist is an individual contributor role within the Cranial & Spinal Technologies Operating Unit, responsible for planning and delivering regulatory projects that support timely market access and ongoing compliance. This position works cross‑functionally to prepare, publish, and manage high‑quality regulatory submissions and related documentation, leveraging specialized knowledge of regulatory requirements and electronic document systems. The role may mentor colleagues or provide direction to lower‑level professionals while ensuring work is delivered in alignment with Medtronic policies, procedures, and quality standards. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be assigned. Key Responsibilities * Prepare, publish, perform quality control, and deliver paper and electronic components of regulatory submissions, including initial large marketing authorization applications and electronic common technical documents (eCTD). * Produce submissions using electronic publishing tools in compliance with document management standards and applicable regulatory/quality requirements. * Manage activities related to enterprise-wide regulatory management systems, including systems coordination, user support, and data maintenance. * Develop and deliver training for colleagues on regulatory systems, tools, and related processes. * Contribute to the development, implementation, and continuous improvement of regulatory systems and processes, including input to system design and enhancements. * Prepare, submit, track, index, and archive paper and electronic submissions such as supplements, amendments, annual reports, general correspondence, adverse event reports, and promotional material filings. * Collaborate cross‑functionally (e.g., with R&D, Quality, Clinical, Marketing) to collect required information, resolve issues, and provide clear regulatory status updates, including report‑outs to leadership. Minimum Qualifications * Baccalaureate degree * Minimum of 2 years of relevant experience in a regulated industry Preferred Qualifications * Experience with regulatory or other complex data systems, including data entry, reporting, and troubleshooting. * Demonstrated ability to analyze data and metrics to inform decision‑making and process improvements. * Strong cross‑functional collaboration skills and experience working with diverse stakeholder groups. * Experience preparing or contributing to regulatory submissions (e.g., eCTD, marketing applications, annual reports, amendments, or adverse event reporting). * Strong attention to detail, organizational skills, and ability to manage multiple projects and deadlines. * Effective written and verbal communication skills, including clear report‑outs to leadership. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. **U.S. Work Authorization & Sponsorship ** At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. # **Benefits & Compensation** **Medtronic offers a competitive Salary and flexible Benefits Package** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$74,400.00 - $111,600.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). ## ## The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: [Medtronic benefits and compensation plans](https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) # **About Medtronic** # We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity [here](http://www.medtronic.com). It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find [here](https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.", "summaryDescription" : "Regulatory Affairs Specialist at Medtronic. Skills: Regulatory affairs, Regulatory submissions, Compliance. Prepare regulatory submissions. 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for international submissions, Maintain worldwide regulatory requirements proficiency, Establish RA department relationships, Maintain RA department relationships, Establish cross functional team relationships, Maintain cross functional team relationships, Develop positive relationships with device reviewers, Maintain positive relationships with device reviewers, Assist in negotiations with FDA, Assist in negotiations with regulatory agencies", "teamCollaboration" : "Cross functional teams; RA department; Device reviewers", "domainKnowledge" : "Class II devices; Class III devices; Medical Device Directive; Medical Device Regulation", "domainList" : [ "class-ii-devices", "class-iii-devices", "medical-device-directive", "medical-device-regulation" ], "domainSpecificKnowledge" : [ "Class II devices", "Class III devices", "Medical Device Directive", "Medical Device Regulation" ], "communicationSkills" : "Written communication; Verbal communication", "documentationSkills" : "Regulatory 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You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. # **A Day in the Life** **Medtronic** At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. **Our Purpose** Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. This position will reside in the Peripheral Vascular Health organization that cares for millions of patients globally with life-enhancing therapies. The Regulatory Affairs Specialist is responsible for worldwide regulatory activities for new and existing Class II and Class III devices and provide advice on regulatory requirements. The Regulatory Affairs Specialist is responsible for assessing device changes for regulatory implications and for performing relevant regulatory actions in support of the implementation of these changes. This role focuses on a wide variety of regulatory tasks to allow the Regulatory Affairs Specialist to make the most of his/her existing knowledge base while growing his RA skill set daily working within a collaborative team environment. **_Come for a job, stay for a career!_** **A Day in The Life Of:** Responsibilities may include the following and other duties may be assigned. * Lead or compile all materials required in submissions, license renewal and annual registrations. Work with engineers and technical experts to address questions from regulatory agencies. * Provide support to currently marketed products as necessary. This includes reviewing labeling, product or process changes as well as supportive documentation for changes requiring RA agency review. Prepare submissions and reports for FDA or provide support and documentation for international submissions. * Maintain proficiency in worldwide regulatory requirements. * Establish and maintain good relationships within the RA department, cross functional teams and assist in developing and maintaining positive relationships with device reviewers through verbal and written communications. * May assist in negotiations with the FDA or other regulatory agencies for defined projects. * Other tasks, as assigned. **Key Skills & Experience** * Minimum NFQ Level 8 Bachelor’s degree in Regulatory Science, Pharmaceutical, Biomedical or related medical/scientific field with minimum 2 years of relevant experience in medical device industry. * Or Master’s degree in Regulatory Science, Pharmaceutical, Biomedical or related medical/scientific field with no prior experience. Nice to have: * Experience working with Class II/III medical devices. * Experience with FDA requirements, guidance documents, Medical Device Directive (MDD), Medical Device Regulation (MDR), medicinal consultations and/or other global regulatory requirements and quality standards. * Effective negotiation and written/oral communication skills. * Effective interpersonal, organizational and time management skills. * Effective team member. * Detail-oriented **Medtronic offer a competitive salary and flexible Benefits Package** #INDJ #LI-Onsite **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. # **Benefits & Compensation** **Medtronic offers a competitive Salary and flexible Benefits Package** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 48,400.00 EUR - 72,600.00 EUR | This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). # **About Medtronic** # We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity [here](http://www.medtronic.com)", "summaryDescription" : "Regulatory Affairs Specialist at Medtronic. Skills: Regulatory affairs, Medical devices, Global regulatory requirements. Lead submissions. Compile submission materials", "postedDate" : "2026-06-11T08:11:52.704", "createdAt" : "2026-06-12T08:11:52.519", "lastUpdated" : "2026-06-14T23:54:36.471", "ingestTimestamp" : "2026-06-12T08:11:52.519", "mongoId" : "6a2b975774d8ee00a0816dc2", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "sourceUrl" : "https://medtronic.wd1.myworkdayjobs.com/RedeploymentMedtronicCareers/job/Galway-County-Galway-Ireland/Regulatory-Affairs-Specialist_R68241", "salaryBand" : "30k-50k", "hasSalary" : false, "allSkills" : [ "Regulatory requirements", "Device change assessment", "Regulatory submissions", "License renewal", "Annual registrations", "Product changes", "Process changes", "Supportive documentation", "International submissions", "Negotiation", "Interpersonal skills", "Organizational skills", "Time management skills", "Regulatory affairs", "Medical devices", "Global regulatory requirements", "Risk management", "Legal analysis", "Compliance oversight", "Class II devices", "Class III devices", "Medical Device Directive", "Medical Device Regulation" ], "skillCount" : 23, "jobCategory" : "other", "seniorityLevel" : "mid", "dataQualityScore" : 0.8888889, "daysOld" : 3, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Healthcare" }, { "id" : "6a3068eff292fd229cfc619d", "title" : "Wellbeing Practitioner - Prison Lead", "company" : "Catch22", "industry" : "Civic And Social Organization", "salary" : { "min" : 38000.0, "max" : 52000.0, "currency" : "GBP", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Mid-seniority Wellbeing Practitioner in London, UK, within the Healthcare industry, adjusted for company size and specific role responsibilities." }, "location" : "London, England, United Kingdom", "locations" : [ "London", "England", "United Kingdom" ], "certifications" : [ "Evidence of continual professional development" ], "timestamp" : "2026-06-16T09:13:54.184", "fingerprint" : "46f50406acae9d1216e992175409edf778c7557ced675f31fd9587e1a91289f0", "source" : "smartrecruiters", "language" : "en", "applyUrl" : "https://jobs.smartrecruiters.com/Catch22/744000132181039-wellbeing-practitioner", "externalId" : "744000132181039", "industryFunction" : { }, "structuredLocations" : [ { "city" : "London", "state" : "England", "country" : "United Kingdom", "continent" : "eu", "source" : "llm", "workMode" : "onsite", "geo" : "51.5074456,-0.1277653" } ], "locationText" : "London, England, United Kingdom", "employmentType" : "FULL_TIME", "experienceMinYears" : 5, "experienceMaxYears" : 10, "experienceLevel" : "mid", "technicalSkills" : "Microsoft Office, Word, Excel", "professionalSkills" : [ "Risk management", "Caseload management", "Needs assessment" ], "hardSkillsList" : [ "Groupwork interventions" ], "softSkillsList" : [ "Confident", "Professional" ], "hardSkills" : [ { "name" : "Groupwork interventions", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Confident" }, { "name" : "Professional" } ], "majorSkills" : "Wellbeing support, Rehabilitation, Caseload management", "majorSkillsList" : [ "Wellbeing support", "Rehabilitation", "Caseload management" ], "coreResponsibilities" : "Manage a caseload of service users, Complete ongoing assessments, Manage individual needs, Manage capacity, Manage opportunity, Manage motivation to rehabilitate, Deliver interventions to support rehabilitation, Work in partnership with local providers, Take account of available risk information, Work in close partnership with delivery partners, Work with HMPPS, Work with the Voluntary Sector, Work with other Criminal Justice organisations", "teamCollaboration" : "Working in partnership; Close partnership with delivery partners", "domainKnowledge" : "Criminal Justice System; Offender management; Resettlement; Veterans in custody; Victim services; Gangs work; Youth justice; Adult male ex-offenders; Lifestyle and Associates pathway; Emotional Wellbeing Services pathway; Social Inclusion pathway", "domainList" : [ "criminal-justice-system", "offender-management", "resettlement", "veterans-in-custody", "victim-services", "gangs-work", "youth-justice", "adult-male-ex-offenders", "lifestyle-and-associates-pathway", "emotional-wellbeing-services-pathway", "social-inclusion-pathway" ], "domainSpecificKnowledge" : [ "Criminal Justice System", "Offender management", "Resettlement", "Veterans in custody", "Victim services", "Gangs work", "Youth justice", "Adult male ex-offenders", "Lifestyle and Associates pathway", "Emotional Wellbeing Services pathway", "Social Inclusion pathway" ], "toolProficiency" : [ "Digital systems" ], "communicationSkills" : "Excellent communication skills", "documentationSkills" : "Recording work", "continuousLearning" : "Continual professional development", "problemSolvingSkills" : "Identify and recognise risk", "specialRequirements" : "Frequent travel across respective clusters, HMPPS vetting, NPPV, Role-specific security clearances, Online search as due diligence", "outcomesObjectives" : "Improve prospects of service users; Positive influence for change", "qualificationsBasic" : "Good basic education, Maths and English GCSE or equivalent, Experience of working with Microsoft Office, Word and Excel experience", "qualificationsPreferred" : "Qualification relevant to working with those in Criminal Justice System, Criminology/ criminal justice/ social care/ mental health/ IAG/ Family qualification", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "Catch22 exists to help build a society where everyone has a good place to live, good people around them, and a fulfilling purpose. [We call these our '3Ps'.](https://www.catch-22.org.uk/about/our-vision/) Social Justice In [Social Justice](https://www.catch-22.org.uk/expertise/justice/), we work with young people and adults in custody and in the community, providing a range of services including offender management and resettlement, mentoring, veterans in custody, victim services, gangs work, and youth justice. We believe that with effective support mechanisms, and the correct interventions, we can change the ideology of service users, helping them to desist from crime, and reach their true potential. Personal Wellbeing This post presents an exciting opportunity to become a frontline practitioner, within our Personal Wellbeing services, in the London region. Commissioned by HMPPS, these services are focused on supporting adult male ex-offenders across the following four pathways: * Family and Significant Others * Lifestyle and Associates * Emotional Wellbeing Services * Social Inclusion This advert is rolling for multiple roles across our pan London Personal Wellbeing Contract, as a Wellbeing Practitioner - Prison Lead. These roles are based at one of our below hubs with frequent travel across their respective clusters (please state a preference of base as part of your application): * Tottenham * Croydon * Romford * Canning Town * Kings Cross * Brixton * Ealing * Lewisham Wellbeing Practitioner - Prison Lead About You * Confident, professional, and adaptable, with the ability to work effectively in challenging environments. * Excellent communication skills, with the ability to build and manage great working relationships, sharing knowledge and skills to deliver shared goals. * Able to effectively motivate and support service users in their ability to change, through both one to one and groupwork interventions. * Able to identify and recognise risk, and act according to risk management procedures, to enable service users to manage their own safety, and the safety of others. * Able to proactively manage a caseload of service users, utilising digital systems, and appropriately sharing information, with excellent attention to detail when recording work and meeting deadlines. About the role The role of Wellbeing Practitioner - Prison Lead is an excellent opportunity to directly support service users in addressing their needs, and improving their prospects, as a positive influence for change. * Managing a caseload of service users, completing ongoing assessments and management of individual needs, capacity, opportunity, and motivation to rehabilitate. * Delivering interventions to support rehabilitation. * Working in partnership with a range of local providers, taking account of available risk information. * Working in close partnership with delivery partners, HMPPS, the Voluntary Sector, and other Criminal Justice organisations. Please click [here](https://c.smartrecruiters.com/sr-company-attachments-prod-dc5/5a74948ee4b0aff9e7ce8758/21627919-0252-4455-9c8e-6d9f0ed51364?r=s3-eu-central-1) to view the full Job Description. ## Qualifications * Good basic education, including Maths and English GCSE or equivalent. * Evidence of continual professional development. * Experience of working with Microsoft Office - Word and Excel. * Desirable: any qualification relevant to working with those in Criminal Justice System, for example criminology/ criminal justice/ social care/ mental health/ IAG/ Family. ## Additional Information Those interested in applying for this opportunity should review the [Job Description & Person Specification](https://c.smartrecruiters.com/sr-company-attachments-prod-dc5/5a74948ee4b0aff9e7ce8758/21627919-0252-4455-9c8e-6d9f0ed51364?r=s3-eu-central-1) to find out more. If you have any questions about the role or recruitment process, please see our contact information on the [Candidate Help Page](https://docs.google.com/document/d/16jVsq0CbigXFYpCnEn5MWnGbYXiae71_Y3oDEx3K00s/edit?usp=sharing). Please use reference REF2582S in your message so that we can identify the opportunity. When applying please be cautious over the answers you provide. If you select “NO” to the screening question regarding Right to Work in the UK, your application will automatically be closed. Contract: Permanent Hours & work pattern: Full time, 38 hours per week. Salary: £29,684 Career Family & Scale: Operations – Practitioner, London Location: This is a community-based role, with travel across various delivery and training sites across London. Interview process: Recruitment for this role will include a 2-part recruitment process - group interviews based on skills, and then if successful, a competency panel interview. Unless otherwise stated, interviews will be arranged as suitable candidates are identified, so early application is strongly advised. Where a deadline is advertised, Catch22 reserves the right to withdraw the post from advertisement without notice. Closing Date: 1630 on 3rd of June 2026. Catch22 reserves the right to withdraw the vacancy at any time, for any reason before the stated closing date. We aim to review applications as quickly as possible. However, due to the volume of interest we receive, we may not be able to contact all applicants individually. If you have not heard from us within two weeks of the closing date, please assume that your application has not been successful this time. Screening: Successful admission to post subject to enhanced DBS check, HMPPS Enhanced Level 1 vetting check, and employer Right To Work in the UK check. The post-holder must have right to work in the UK. Catch22 does not currently provide a licence to sponsor visas but please see this[ register](https://www.gov.uk/government/publications/register-of-licensed-sponsors-workers) to see those that do. Shift patterns: Potential for 1/2 home-working days for admin purposes (not contractually obliged, but part of our wellbeing support). Possibility of flexible work requests, as part of our Catch22 Ways of Working scheme, this includes optional 4-day weeks, or 9-day fortnights working patterns. Proactive Recruitment Strategy: We are proactively recruiting to build a pool of pre-cleared candidates for future vacancies, for some of our opportunities. While we may not be able to offer an immediate role, successful applicants will undergo all relevant pre-employment checks, enabling them to join our workforce promptly when a position becomes available. This approach is based on expected leavers over the coming 3 month period and ensures a smooth transition into the team as opportunities arise. To Apply: Please provide your CV and cover letter, along with the completion of the screening questions to express your interest in this opportunity. Please note, in the interest of safer recruitment and ensuring that applicants are a right fit for the role, submitted applications must contain a CV, satisfactory responses to the screening questions, and information detailing interest in the role, to be considered for this position. Use of AI (Artificial Intelligence) should not be used to exaggerate skills & experiences, create generic responses that are not unique to the individual, and for any assessments used by the Hiring Team to measure an individual's natural abilities. Catch22’s Commitment to Opportunity & Progression At Catch22 we are proud of our commitment in supporting people develop in their careers and progress in our organisation. In 2024, within our Justice Hub, we have 68% of those in management roles that originally joined Catch22 in the frontline workforce and some worked across a number of roles and Leadership positions before joining management. This allows us to have a highly experienced management group and provides development opportunities for those in our much valued front-line. Catch22’s Commitment to Ban the Box Catch22 is proud to have “[Banned the Box](https://www.bitc.org.uk/fact-sheet/employers-that-have-banned-the-box/)”. This means that we do not ask for candidates to disclose criminal convictions at the application stage. Instead, we invite disclosures at interview stage, and encourage them at the offer stage. Please see our [statement of commitment on hiring people with convictions](https://www.catch-22.org.uk/work-with-us/jobs-and-placements/diversity-and-inclusion/) for more information. Missing Links? A number of our job aggregators do not allow for us to use hyperlinks in our advertisements. To view information contained within these links, please click apply, where you will be taken to the advert in our ATS. This will allow you to view and access the links contained within our adverts. Social Media Search Please note, we may conduct an online search as part of our due diligence checks for successful candidate(s). This will involve a search of all publicly available information online and in social media. Vetting Requirements This role is subject to the satisfactory completion of relevant pre-employment checks, which may include HMPPS vetting, NPPV, or other role-specific security clearances. Any offer of employment will be conditional upon the successful outcome of these checks. Where clearance is not granted, or is subsequently withdrawn, Catch22 reserves the right to withdraw the offer of employment. Catch22 Justice requests no contact from agencies or media sales [Benefits](https://www.catch-22.org.uk/work-with-us/jobs-and-placements/benefits/) / [Apply for Opportunities](https://www.catch-22.org.uk/work-with-us/jobs-and-placements/vacancies/) / [recruitment process](https://www.catch-22.org.uk/work-with-us/jobs-and-placements/recruitment-process/) / [Recruitment Policy](https://www.catch-22.org.uk/resources/recruitment-policy/) / [Set up Job Alerts](https://subscriptions.smartrecruiters.com/job-alert/en-gb-oxendict/widget/30B55611-09A2-49FE-8D6D-B58CAD502461?bg=00ae41&dcr_id=null) Catch22 is committed to rigorous safeguarding and safer recruitment practices; ensuring that every individual within the organisation has been safely and appropriately checked.", "summaryDescription" : "Wellbeing Practitioner - Prison Lead at Catch22. Skills: Wellbeing support, Rehabilitation, Caseload management. Manage a caseload of service users. Complete ongoing assessments", "postedDate" : "2026-06-15T11:46:07.000", "createdAt" : "2026-06-15T23:59:44.109", "lastUpdated" : "2026-06-16T09:13:54.184", "ingestTimestamp" : "2026-06-15T23:59:44.109", "mongoId" : "6a3068eff292fd229cfc619d", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "30k-50k", "hasSalary" : false, "allSkills" : [ "Groupwork interventions", "Confident", "Professional", "Wellbeing support", "Rehabilitation", "Caseload management", "Risk management", "Needs assessment", "Criminal Justice System", "Offender management", "Resettlement", "Veterans in custody", "Victim services", "Gangs work", "Youth justice", "Adult male ex-offenders", "Lifestyle and Associates pathway", "Emotional Wellbeing Services pathway", "Social Inclusion pathway", "Evidence of continual professional development", "Digital systems" ], "skillCount" : 21, "jobCategory" : "operations", "jobSubcategory" : "general", "seniorityLevel" : "Mid", "dataQualityScore" : 1.0, "daysOld" : 0, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Healthcare", "llmIndustryConfidence" : 0.95 }, { "id" : "6a2c7de674d8ee00a095129b", "title" : "Senior Associate/Strategist – Regulatory Affairs (APAC CMC)", "company" : "ClinChoice", "industry" : "Pharma", "salary" : { "min" : 2200000.0, "max" : 3500000.0, "currency" : "INR", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Senior Associate/Strategist in the Pharma industry in India, adjusted for seniority and company size." }, "location" : "India", "locations" : [ "India" ], "timestamp" : "2026-06-15T09:36:23.363", "fingerprint" : "5d111d51c069efbd5703cb08553581f513ce644d603a506de60bb09e2f7b4344", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.eu.greenhouse.io/clinchoice/jobs/4896358101", "externalId" : "4896358101", "industryFunction" : { }, "structuredLocations" : [ { "country" : "India", "continent" : "as", "workMode" : "onsite" } ], "locationText" : "India", "employmentType" : "FULL_TIME", "minimumEducation" : "Bachelor's", "experienceMinYears" : 5, "experienceMaxYears" : 9, "experienceLevel" : "Senior", "professionalSkills" : [ "Regulatory affairs", "Technical writing", "Editing", "Project management", "Risk management" ], "hardSkillsList" : [ "Regulatory submissions", "CMC sections", "Health Authority questions", "Regulatory compliance", "ICH guidelines", "Quality control", "Scientific data", "Regulatory documentation", "Medicinal products", "Submission approvals" ], "hardSkills" : [ { "name" : "Regulatory submissions", "level" : "intermediate" }, { "name" : "CMC sections", "level" : "intermediate" }, { "name" : "Health Authority questions", "level" : "intermediate" }, { "name" : "Regulatory compliance", "level" : "intermediate" }, { "name" : "ICH guidelines", "level" : "intermediate" }, { "name" : "Quality control", "level" : "intermediate" }, { "name" : "Scientific data", "level" : "intermediate" }, { "name" : "Regulatory documentation", "level" : "intermediate" }, { "name" : "Medicinal products", "level" : "intermediate" }, { "name" : "Submission approvals", "level" : "intermediate" } ], "majorSkills" : "Regulatory Affairs, CMC Regulatory, Technical Writing", "majorSkillsList" : [ "Regulatory Affairs", "CMC Regulatory", "Technical Writing" ], "coreResponsibilities" : "Author regulatory submissions, Review CMC sections, Ensure regulatory compliance, Collaborate with SMEs, Gather information, Maintain document quality, Manage timelines, Identify CMC regulatory issues, Propose mitigation strategies, Interpret regulations, Guide teams on regulations, Expedite submission, Obtain approvals", "teamCollaboration" : "Subject matter experts; Scientists; Quality assurance; Manufacturing teams; Regulatory affairs colleagues; Cross-functional teams", "projectManagementSkills" : [ "Manage projects" ], "domainKnowledge" : "APAC CMC; New Drug Applications; Marketing Authorization Applications; Global regions; Manufacture of medicinal products; Control of medicinal products", "domainList" : [ "apac-cmc", "new-drug-applications", "marketing-authorization-applications", "global-regions", "manufacture-of-medicinal-products", "control-of-medicinal-products" ], "domainSpecificKnowledge" : [ "APAC CMC", "New Drug Applications", "Marketing Authorization Applications", "Global regions", "Manufacture of medicinal products", "Control of medicinal products" ], "toolProficiency" : [ "ECTD format" ], "communicationSkills" : "Communication skills; Technical writing; Editing", "documentationSkills" : "Regulatory documentation; CMC sections", "problemSolvingSkills" : "Identify potential CMC Regulatory issues; Propose mitigation strategies", "outcomesObjectives" : "Timely completion of submissions", "qualificationsBasic" : "Bachelor's degree or higher, 5-9 years relevant experience, Authoring CMC sections, Technical writing expertise, Knowledge of CMC regulatory requirements, Experience with eCTD format", "qualificationsPreferred" : "Background in pharmaceutical manufacturing, Background in quality control", "rawDescription" : "Responsibilities: Authoring regulatory submissions: Writing and reviewing the CMC sections for new e. g. New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs) and lifecycle maintenance regulatory filings including responses to Health Authority’s questions. Ensuring regulatory compliance: Making sure that all documents align with the requirements of regulatory bodies as well as International Council for Harmonisation (ICH) guidelines. Collaborating with subject matter experts (SMEs): Working closely with scientists, quality assurance (QA), manufacturing teams, and regulatory affairs colleagues to gather accurate and complete information about a drug's composition, manufacturing process, and quality control. Maintaining document quality: Ensuring completion of high-quality documents i. e. clear, concise, scientifically accurate, and consistent in style and format, complying with regulatory guidelines and internal processes within timelines. Managing timelines: Adhering to strict project schedules to ensure timely completion of submissions. Identify, Assess and Communicate potential CMC Regulatory issues and propose mitigation strategies. Understands, interprets and guides teams on regulations and policies related to manufacture and control of medicinal products to expedite the submission, review and obtain approvals. Essential skills and qualifications Educational background: A bachelor's degree or higher in a scientific field, such as Chemistry, Pharmaceutical Sciences, or a related discipline. Experience: Minimum of 5 ~ 9 years of relevant work experience working within a Regulatory Affairs Department with direct accountability for deliverables. Pharmaceutical experience: Prior experience authoring CMC sections for regulatory submissions is a standard requirement. Technical writing expertise: Exceptional technical writing, editing, and communication skills are required to translate complex scientific data into clear regulatory documentation. Regulatory knowledge: A strong knowledge of CMC regulatory requirements for multiple global regions (e.g., APAC, U.S., EU) is essential. Experience with the electronic Common Technical Document (eCTD) format is also crucial. Industry familiarity: A background in pharmaceutical manufacturing or quality control is often beneficial. Collaboration and project management: The ability to work independently, manage projects, and communicate effectively with cross-functional teams is critical. Detail-oriented: Meticulous attention to detail is necessary to ensure the accuracy and completeness of submissions.", "summaryDescription" : "Senior Associate/Strategist – Regulatory Affairs (APAC CMC) at ClinChoice. Skills: Regulatory Affairs, CMC Regulatory, Technical Writing. Author regulatory submissions. Review CMC sections", "postedDate" : "2026-06-14T03:07:56.137", "createdAt" : "2026-06-14T03:07:56.137", "lastUpdated" : "2026-06-15T09:36:23.363", "ingestTimestamp" : "2026-06-14T03:07:56.137", "mongoId" : "6a2c7de674d8ee00a095129b", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "200k+", "hasSalary" : false, "allSkills" : [ "Regulatory submissions", "CMC sections", "Health Authority questions", "Regulatory compliance", "ICH guidelines", "Quality control", "Scientific data", "Regulatory documentation", "Medicinal products", "Submission approvals", "Regulatory Affairs", "CMC Regulatory", "Technical Writing", "Regulatory affairs", "Technical writing", "Editing", "Project management", "Risk management", "Manage projects", "APAC CMC", "New Drug Applications", "Marketing Authorization Applications", "Global regions", "Manufacture of medicinal products", "Control of medicinal products", "ECTD format" ], "skillCount" : 26, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Senior", "dataQualityScore" : 1.0, "daysOld" : 1, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Pharma", "llmIndustryConfidence" : 0.95 }, { "id" : "6a2c8ba474d8ee00a09734e2", "title" : "Assistant, Business Affairs - Publishing", "company" : "UTA", "industry" : "United Talent Agency", "salary" : { "min" : 23.0, "max" : 25.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : false }, "location" : "New York 888 Office", "locations" : [ "New York 888 Office" ], "certifications" : [ "New York Bar license" ], "timestamp" : "2026-06-16T01:01:18.784", "fingerprint" : "63120d9fd71232b004af95c987458e30ad0f138c807ed5aee3ab5dce7ef90afd", "source" : "ashby", "language" : "en", "applyUrl" : "https://jobs.ashbyhq.com/united-talent-agency/94989b6f-55c5-4813-9429-438ed01975f4/application", "externalId" : "94989b6f-55c5-4813-9429-438ed01975f4", "industryFunction" : { }, "structuredLocations" : [ { "city" : "New York", "state" : "New York", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "40.7127281,-74.0060152" } ], "locationText" : "New York, New York, United States", "employmentType" : "FULL_TIME", "minimumEducation" : "Bachelor's", "professionalSkills" : [ "Contract administration" ], "hardSkillsList" : [ "Proofing contracts", "Proofing correspondence" ], "softSkillsList" : [ "Problem-solving" ], "hardSkills" : [ { "name" : "Proofing contracts", "level" : "intermediate" }, { "name" : "Proofing correspondence", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Problem-solving" } ], "majorSkills" : "Book publishing, Contract review", "majorSkillsList" : [ "Book publishing", "Contract review" ], "coreResponsibilities" : "Manage phone calls, Schedule conference calls, Manage calendar, Schedule meetings, Coordinate meetings, Manage contract administration process, Track deals, Track contracts, Process contracts, Maintain contract files, Read publishing contract language, Confirm delivery date, Confirm territories granted, Research existing agreements, Find relevant agreements, Assist in proofing contracts, Assist in proofing correspondence, Review amendments, Negotiate amendments, Review publishing agreements, Negotiate publishing agreements", "teamCollaboration" : "Work with people at different levels; Work with internal stakeholders; Work with external stakeholders; Work with agents; Work with senior executives; Work with business affairs executives; Work with writers; Work with agency clients; Work with attorneys; Work with other in-house divisions; Work with assistants; Work with coordinators", "projectManagementSkills" : [ "Manage multiple projects" ], "domainKnowledge" : "Book publishing; Publishing contracts", "domainList" : [ "book-publishing", "publishing-contracts" ], "domainSpecificKnowledge" : [ "Book publishing", "Publishing contracts" ], "toolProficiency" : [ "Excel", "PowerPoint", "Adobe", "Outlook", "Word" ], "communicationSkills" : "Written communication; Verbal communication", "problemSolvingSkills" : "Problem-solving approach", "qualificationsBasic" : "Able to review and understand contracts, Able to work effectively with people, Capable of managing multiple projects simultaneously, Able to operate in a timely manner, Proficiency in Excel, Proficiency in PowerPoint, Proficiency in Adobe, Proficiency in Outlook, Proficiency in Word, Research skills", "qualificationsPreferred" : "JD degree preferred, Active New York Bar license preferred, Previous experience within a talent agency preferred, Previous experience within a literary agency preferred, Previous experience within a publisher preferred", "workSiteFlexibility" : "Onsite", "rawDescription" : "UTA seeks a Business Affairs Assistant in the Publishing Business Affairs department for our New York office. You will provide comprehensive administrative support to two Business Affairs Executives. The Business Affairs Assistant will handle a variety of administrative duties and will be integral to the contract administration process. Candidates must have experience in a fast-paced environment, the ability to manage multiple projects at a time, experience in handling administrative duties, and have an interest in book publishing. The salary range for this role is $23.00 to $25.00/hour commensurate with experience and skills. What You Will Do - Phone management – answering and transferring calls, scheduling & coordinating conference calls (including multi-party, multi-time zone conf calls). - Calendar management – daily calendar management; scheduling and coordinating meetings, both in-office and virtual. - Managing the contract administration process, including tracking deals and contracts, processing contracts, and maintaining of contracts files. - Reading and understanding basic publishing contract language (e.g., confirming the delivery date for a work or the territories granted to publisher). - Researching existing agreement(s) database to find previous relevant agreements to serve as precedents/templates. - Assisting in proofing contracts and correspondence. - Based on expertise and capabilities, opportunity to review and negotiate basic amendments and publishing agreements under the supervision of an Executive. What You Will Need - JD degree preferred or bachelor’s degree with requisite experience. - Active New York Bar license or other state preferred. - Previous experience within a talent agency, literary agency, or publisher strongly preferred. - Able to review and understand contracts. - Able to work effectively with people at different levels, internally, and externally (including agents, senior executives, executives/business affairs, writers and other agency clients, attorneys, other in-house divisions, as well as other assistants and coordinators). - Capable of managing multiple projects simultaneously with minimal supervision. - Able to operate in a timely manner, with careful attention to detail in a fast-paced, high-volume environment. - Excellent communication skills, both written and verbal. - Employs a problem-solving approach and is highly organized. - General business knowledge and interest in the publishing business. - Strong proficiency in Excel, PowerPoint, Adobe, Outlook, Word, and strong research skills. What You Will Get - The unique and exciting opportunity to work at one of a leading global entertainment companies - Access to the tools, leadership, and resources you will need to create and drive a center of excellence - The opportunity to do the best work of your career - Work in an inclusive and diverse company culture - Competitive programs to support your well-being - Experience working in a collaborative environment with room to grow About UTA UTA is a premier global talent agency built for the future of media and entertainment. The agency's diversified platform and best-in-class, client-first approach is innovative, collaborative, and positioned to lead in an evolving market. UTA represents the most celebrated artists, creatives, and brands, from icons and legends to next-generation talent. Its integrated capabilities span film and television, music, comedy, creators, sports, brands, news, publishing, speakers, theater, and more. It is based in Los Angeles with offices in the U.S., London, and Munich. For more information: https://www.unitedtalent.com/about/ UTA and its Affiliated Companies are Equal Employment Opportunity employers and welcome all job seekers. https://www.unitedtalent.com/privacy-policy", "summaryDescription" : "Assistant, Business Affairs - Publishing at UTA. Skills: Book publishing, Contract review. Manage phone calls. Schedule conference calls", "createdAt" : "2026-06-14T19:11:14.908", "lastUpdated" : "2026-06-16T01:01:18.784", "ingestTimestamp" : "2026-06-14T19:11:14.908", "mongoId" : "6a2c8ba474d8ee00a09734e2", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 47840, "salaryAnnualMax" : 52000, "salaryBand" : "30k-50k", "hasSalary" : true, "allSkills" : [ "Proofing contracts", "Proofing correspondence", "Problem-solving", "Book publishing", "Contract review", "Contract administration", "Manage multiple projects", "Publishing contracts", "New York Bar license", "Excel", "PowerPoint", "Adobe", "Outlook", "Word" ], "skillCount" : 14, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Entry", "dataQualityScore" : 0.7777778, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Media", "llmIndustryConfidence" : 0.95 }, { "id" : "6a2a751974d8ee00a0656bc4", "title" : "Accounting and Regulatory Reporting Manager, Canada", "company" : "Coinbase", "industry" : "FinServ", "salary" : { "min" : 135000.0, "max" : 185000.0, "currency" : "CAD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market data for a Manager in FinTech in Alberta, Canada, adjusted for seniority and company size." }, "location" : "Alberta, Canada", "locations" : [ "Alberta", "Canada" ], "certifications" : [ "CPA designation" ], "timestamp" : "2026-06-14T22:17:20.722", "fingerprint" : "8f02d488d5162c3beb18eaaf2e8eb73be74c6b124b395b157f036e5fb6635979", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://www.coinbase.com/careers/positions/7993445?gh_jid=7993445", "externalId" : "7993445", "industryFunction" : { }, "structuredLocations" : [ { "state" : "Alberta", "country" : "Canada", "continent" : "na", "workMode" : "onsite" } ], "locationText" : "Alberta, Canada", "experienceMinYears" : 6, "experienceLevel" : "Manager", "technicalSkills" : "Python, R, SQL, Bloomberg Terminal, Reuters Eikon, FactSet", "professionalSkills" : [ "Regulatory reporting", "Financial analysis", "Capital adequacy reporting", "Liquidity management", "Internal controls", "Process automation" ], "hardSkillsList" : [ "IFRS accounting", "Regulatory filings", "Financial reporting", "Reconciliations", "Audit support", "Process enhancement" ], "softSkillsList" : [ "Leadership" ], "hardSkills" : [ { "name" : "IFRS accounting", "level" : "intermediate" }, { "name" : "Regulatory filings", "level" : "intermediate" }, { "name" : "Financial reporting", "level" : "intermediate" }, { "name" : "Reconciliations", "level" : "intermediate" }, { "name" : "Audit support", "level" : "intermediate" }, { "name" : "Process enhancement", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Leadership" } ], "majorSkills" : "Regulatory reporting, IFRS, Securities regulation", "majorSkillsList" : [ "Regulatory reporting", "IFRS", "Securities regulation" ], "coreResponsibilities" : "Own preparation of regulatory filings, Own review of regulatory filings, Own submission of regulatory filings, Ensure accuracy of regulatory filings, Ensure on-time delivery of regulatory filings, Drive monthly management reporting, Drive board-level financial analysis, Lead maintenance of IFRS books of account, Perform reconciliations, Prepare adjusting entries, Provide supporting documentation for audit, Provide supporting documentation for regulatory examination, Partner with Tax, Partner with Treasury, Partner with Legal, Partner with outsourced service providers, Coordinate liquidity management, Monitor SLA performance, Monitor KPI performance, Resolve cross-functional financial reporting queries, Build scalable reporting processes, Enhance scalable reporting processes, Build automation for reporting, Enhance automation for reporting, Build internal controls, Enhance internal controls, Serve as primary point of contact for regulators, Respond to regulatory inquiries, Manage regulatory examinations, Provide ad hoc information requests", "teamCollaboration" : "Cross-functional teams; External regulators", "projectManagementSkills" : [ "Project leadership" ], "domainKnowledge" : "IFRS; Canadian securities regulation; NI 31-103; Form 31-103F1; CIRO capital adequacy rules; Crypto environment", "domainList" : [ "ifrs", "canadian-securities-regulation", "ni-31-103", "form-31-103f1", "ciro-capital-adequacy-rules", "crypto-environment" ], "domainSpecificKnowledge" : [ "IFRS", "Canadian securities regulation", "NI 31-103", "Form 31-103F1", "CIRO capital adequacy rules", "Crypto environment" ], "toolProficiency" : [ "Bloomberg Terminal", "Reuters Eikon", "FactSet" ], "communicationSkills" : "Board-level reporting; Financial analysis presentation", "documentationSkills" : "Regulatory filings", "problemSolvingSkills" : "Root cause analysis", "outcomesObjectives" : "Reduce manual effort; Support growth trajectory", "qualificationsBasic" : "6+ years experience in regulatory reporting or finance, 3+ years in regulated entity preparing filings, CPA designation, Deep knowledge of IFRS, Knowledge of Canadian securities regulatory reporting, Proven track record preparing financial reports, Proven track record presenting financial reports, Direct experience interacting with securities regulators, Demonstrated ability to lead cross-functional projects", "qualificationsPreferred" : "CFA charterholder preferred, FRM preferred, Series 7/63/65 preferred", "remoteFriendly" : true, "workSiteFlexibility" : "Remote", "rawDescription" : "Ready to do the most impactful work of your career? At Coinbase, we are uncompromising on our mission to increase economic freedom. The bar is high, the environment is intense, and we like it that way. This isn't a place for complacency, it’s a place to be pushed past your perceived limits. If you're ready to build the future of finance alongside people who refuse to settle for \"good enough,\" you belong here. Coinbase is a remote-first, but not remote-only company. Expect to get together quarterly for intense in-person working sessions called “surges.” learn more about working at Coinbase. Coinbase Canada seeks an Accounting and Regulatory Reporting Manager to join our Global Financial and Regulatory Reporting team within Finance. You'll serve as the primary Finance owner for all recurring regulatory filings, including Form 31-103F1 and CIRO Form 1, while maintaining IFRS books of account and partnering with Tax, Treasury, and Legal to ensure capital adequacy. This is a technical, high-impact role where you'll design scalable reporting processes, build robust internal controls, and automate reporting cycles for a high-growth crypto environment. What you'll do: Own the preparation, review, and submission of all recurring regulatory filings (Form 31-103F1, CIRO Form 1, and other OSC/CIRO submissions), ensuring accuracy and on-time delivery. Drive monthly management reporting and board-level financial analysis for Coinbase Canada, including variance commentary and capital adequacy reporting under IFRS. Lead the maintenance of parallel IFRS books of account, including all reconciliations, adjusting entries, and supporting documentation required for audit and regulatory examination. Partner with Tax, Treasury, Legal, and outsourced service providers to coordinate liquidity management, monitor SLA/KPI performance, and resolve cross-functional financial reporting queries. Build and enhance scalable reporting processes, automation, and internal controls that reduce manual effort and support Coinbase Canada's growth trajectory. Strengthen relationships with external regulators (OSC, CIRO) by serving as Finance's primary point of contact for regulatory inquiries, examinations, and ad hoc information requests. Required Skills and Experience: 6+ years of experience in regulatory reporting or finance at a bank, fintech, securities dealer, investment dealer, financial regulatory agency, or professional services firm serving financial institution clients, with at least 3 years in a regulated entity preparing or reviewing filings for a securities regulator (e.g., OSC, CIRO/IIROC). CPA designation (or equivalent) with deep, hands-on knowledge of IFRS and Canadian securities regulatory reporting requirements, including NI 31-103, Form 31-103F1, and CIRO capital adequacy rules. Proven track record of preparing and presenting financial and regulatory reports to board-level and senior management audiences. Direct experience interacting with securities regulators (e.g., OSC, CIRO/IIROC, provincial securities commissions) during examinations, inquiries, or routine filings. Demonstrated ability to lead cross-functional projects (e.g., vendor transitions, system integrations, reporting automation) from scoping through delivery in a management capacity. Utilizes generative AI responsibly, maintaining human oversight to deliver business-ready outputs and drive measurable improvements in workflow efficiency, cost, and quality. Position ID: P75564 #LI-Remote Pay Transparency Notice: The target annual base salary for this position can range as detailed below. Total compensation may also include equity and bonus eligibility and benefits (including medical, dental, and vision). Annual base salary range (excluding equity and bonus): $170,000—$170,000 CAD Please be advised that each candidate may submit a maximum of four applications within any 30-day period. We encourage you to carefully evaluate how your skills and interests align with Coinbase's roles before applying. Commitment to Equal Opportunity Coinbase is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, sex, gender expression or identity, sexual orientation or any other basis protected by applicable law. Coinbase will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state and local law. For US applicants, you may view the Employee Rights and the Know Your Rights notices by clicking on their corresponding links. Additionally, Coinbase participates in the E-Verify program in certain locations, as required by law. Coinbase is also committed to providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please contact us at accommodations[at]coinbase.com to let us know the nature of your request and your contact information. For quick access to screen reading technology compatible with this site click here to download a free compatible screen reader (free step by step tutorial can be found here). Global Data Privacy Notice for Job Candidates and Applicants Depending on your location, the General Data Protection Regulation (GDPR) and California Consumer Privacy Act (CCPA) may regulate the way we manage the data of job applicants. Our full notice outlining how data will be processed as part of the application procedure for applicable locations is available here. By submitting your application, you are agreeing to our use and processing of your data as required. For US applicants only, by submitting your application you are agreeing to arbitration of disputes as outlined here. AI Disclosure For select roles, Coinbase is piloting an AI tool based on machine learning technologies to conduct initial screening interviews to qualified applicants. The tool simulates realistic interview scenarios and engages in dynamic conversation. A human recruiter will review your interview responses, provided in the form of a voice recording and/or transcript, to assess them against the qualifications and characteristics outlined in the job description. For select roles, Coinbase is also piloting an AI interview intelligence platform to transcribe and summarize interview notes, allowing our interviewers to fully focus on you as the candidate. The above pilots are for testing purposes and Coinbase will not use AI to make decisions impacting employment. To request a reasonable accommodation due to disability, please contact accommodations[at]coinbase.com", "summaryDescription" : "Accounting and Regulatory Reporting Manager, Canada at Coinbase. Skills: Regulatory reporting, IFRS, Securities regulation. Own preparation of regulatory filings. Own review of regulatory filings", "postedDate" : "2026-06-11T18:57:32.833", "createdAt" : "2026-06-11T18:57:32.833", "lastUpdated" : "2026-06-14T22:17:20.722", "ingestTimestamp" : "2026-06-11T18:57:32.833", "mongoId" : "6a2a751974d8ee00a0656bc4", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "100k-150k", "hasSalary" : false, "allSkills" : [ "IFRS accounting", "Regulatory filings", "Financial reporting", "Reconciliations", "Audit support", "Process enhancement", "Leadership", "Regulatory reporting", "IFRS", "Securities regulation", "Financial analysis", "Capital adequacy reporting", "Liquidity management", "Internal controls", "Process automation", "Project leadership", "Canadian securities regulation", "NI 31-103", "Form 31-103F1", "CIRO capital adequacy rules", "Crypto environment", "CPA designation", "Bloomberg Terminal", "Reuters Eikon", "FactSet" ], "skillCount" : 25, "jobCategory" : "finance", "jobSubcategory" : "finance-&-accounting", "dataQualityScore" : 0.8888889, "daysOld" : 3, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "FinServ" }, { "id" : "6a2ce99574d8ee00a0a6e34e", "title" : "Benefits and Wellbeing Manager", "company" : "Woodard & Curran", "industry" : "Human Resources", "salary" : { "min" : 100000.0, "max" : 195000.0, "currency" : "USD", "frequency" : "yearly" }, "location" : "Virtual", "locations" : [ "Virtual" ], "certifications" : [ "CEBS certification preferred" ], "timestamp" : "2026-06-16T01:06:50.187", "fingerprint" : "75b4cf456ca8de06ccfa89b68dedfb0a5e50ecee8ce52471b971e36d94db05fb", "source" : "lever", "language" : "en", "applyUrl" : "https://jobs.lever.co/woodardcurran/1140cffe-f9e3-4a1b-8118-6373cf4ccfb3/apply", "externalId" : "1140cffe-f9e3-4a1b-8118-6373cf4ccfb3", "industryFunction" : { }, "structuredLocations" : [ { "workMode" : "remote" } ], "locationText" : "", "employmentType" : "FULL_TIME", "experienceLevel" : "Manager", "teamCollaboration" : "HR team; External vendors; Employees", "projectManagementSkills" : [ "Program management" ], "domainKnowledge" : "Employee benefits; Wellness programs; ERISA; ACA", "domainList" : [ "employee-benefits", "wellness-programs", "erisa", "aca" ], "domainSpecificKnowledge" : [ "Employee benefits", "Wellness programs", "ERISA", "ACA" ], "communicationSkills" : "Employee support", "continuousLearning" : "Stay updated on benefits trends", "problemSolvingSkills" : "Data analysis; Data interpretation", "qualificationsBasic" : "Bachelor's degree, 5+ years of experience in benefits administration, Experience with HRIS systems", "qualificationsPreferred" : "Master's degree preferred, CEBS certification preferred, Experience with wellness program design", "remoteFriendly" : true, "workSiteFlexibility" : "Flexible", "rawDescription" : "## Description Woodard & Curran is a national engineering, science and operations firm with a simple vision for clean water, a safe environment, healthy communities and happy people. As an employee-owned company, we strive to cultivate teams that encourage collaboration in an inclusive culture. We seek talented individuals from all backgrounds to help us address a broad range of water and environmental issues. We prioritize our people, offering opportunities for professional growth, ownership and flexibility. This commitment enables us to make a meaningful impact on our clients, communities and the planet. At Woodard & Curran (W&C), there’s nothing we love more than a tough engineering challenge. We handle a wide range of water and environmental issues; solving complex problems with creativity and tenacity. That’s how we make a difference to our clients, people, and planet. Our company was founded on a simple concept: provide a safe and enjoyable place to work with opportunity, integrity, and commitment, and we will attract talented people. Those people are at the heart of our firm, solving some of the most pressing water and environmental challenges for our clients. As members of the Human Resources team, we are stewards of W&C’s greatest strategic asset: Our People. Our mission is to make sure we have the talent we need to accelerate our growth and achieve our goals, as well as serve our communities and clients, all while providing the employee experience that makes W&C an employer of choice. Come join W&C as part of our Human Resources team as the Benefits & Wellness Manager. Whether it is providing thought leadership around strategic direction, competitive position, and new trends, developing and designing programs, or driving changes necessary to move towards best practices, improve processes, and effectively engage stakeholders, you will have a major impact on all employees here at Woodard & Curran. In this rewarding and fulfilling role, you will work directly with an outstanding HR team reporting to our Chief People Officer, and partnering with Talent Management, Compensation & Compliance, Recruiting, Payroll, and the HR Technology Team.  You will also oversee the Benefits & Wellbeing Specialist. In addition to having a strong understanding of the benefits program, we are looking for someone to join us that is passionate about Wellness and excited to inspire a healthy culture and environment across the company that is inclusive to all. ## Your Role at Woodard & Curran Overall management of all benefit programs and plans, including Health & Wellbeing Plans, Integrated Disability, Leave, and Absence Management programs, Retirement Plans, Life Insurance, Voluntary Benefits Program, Member of the 401K Committee, and address and resolve employee Benefits & Wellbeing questions. Overall Management of Well-Being Program Manage Benefits & Wellbeing Team and Partner with Larger HR Team Open Enrollment, ongoing HRIS Configurations and Acquisition Analysis and Onboarding Vendor Management & Compliance Strategy & Project Management ## What You Will Need To Succeed Bachelor's Degree or equivalent in Business, Human Resources, or related field and 8 – 10 years of progressively responsible experience in Benefits, or a minimum of 14 years of relevant experience. CEBS or other equivalent certification preferred. Self-insured benefit plan experience preferred. Working knowledge of HRIS systems. A can-do approach to handling shifting priorities in a constantly changing organization. Strong interpersonal skills and collaborative style to effectively build relationships with HR business partners, cross-functional teams, external vendors, and any other key stakeholders. Strong operational execution and vendor management skills. Strong knowledge of state and federal laws/regulations regarding employment and employee benefits. Advanced Microsoft Excel and Word skills and demonstrated familiarity and understanding of Outlook or other email. Strong analytical skills. Ability to communicate effectively orally and in writing. ## Additional Information Mutual Dispute Resolution (MDR) As part of our commitment to a fair and respectful workplace, Woodard & Curran uses a Mutual Dispute Resolution (MDR) to help resolve most employment-related concerns efficiently and consistently. What this means: MDR applies to both you and the Company Most workplace-related disputes are resolved through binding arbitration, rather than court proceedings Certain exceptions are outlined in the full agreement If you are offered a position with Woodard & Curran, you will be asked to review and sign the MDR as part of your offer packet. \uD83D\uDD17 Review the full agreement here: Mutual Dispute Resolution Agreement Employee Support & Benefits Retirement Savings: 401(k) Pre-tax or Roth Contributions: The company matches 100% of the first 3% of salary contributed Time away from work: Observed holidays: Choose up to 8 holidays to observe annually Vacation: Accrued based on years of experience and calculated on hours worked Sick time: Paid sick time for non-work-related illness or injury. Parental leave: Up to 80 hours of Paid Parental Leave for child bonding Coverage and support for your needs and well-being: Disability: Paid short- and long-term disability Health: Medical plan options; plus dental and vision plans. Life: Basic employee group life insurance and AD&D benefits; additional voluntary life insurance for employees and families is available through Sun Life. Wellbeing: DarioMind assistance program combined with personalized mental health and wellbeing resources. Workplace Information E-Verify Participation Woodard & Curran participates in the U.S. Department of Homeland Security’s E-Verify program to confirm the employment eligibility of all newly hired employees. As part of this process, we display the required Notice of E-Verify Participation and Right to Work posters. \uD83D\uDD17 View required Right to Work and E-Verify posters here. Equal Employment Opportunity & Accessibility Woodard & Curran is an Equal Opportunity Employer. We are committed to non-discrimination and make employment decisions based on job-related factors. Individuals with disabilities and protected veterans are encouraged to apply. If you require a reasonable accommodation during the application process, please contact Beth Sweitzer. \uD83D\uDD17 View our Equal Employment Opportunity Policy \uD83D\uDD17 View the \"Workplace Discrimination is Illegal\" poster Inclusion & Belonging We welcome individuals from all backgrounds and believe diverse perspectives strengthen our ability to serve clients and communities. As an employee-owned company, we are committed to fostering a respectful and inclusive environment where employees can grow, contribute fully, and deliver meaningful impact. Recruitment Agency Policy We do not accept unsolicited resumes from recruitment agencies. Submissions without a signed agreement in place will be considered unsolicited and not eligible for referral fees. Text Message Communication Notice: To support an efficient hiring process, we may send brief SMS updates or reminders. You may opt out at any time by replying “STOP.” Terms, Privacy & Use of AI in Hiring \uD83D\uDD17Woodard & Curran Terms of Use \uD83D\uDD17Woodard & Curran Privacy Statement We may use artificial intelligence (AI) tools to support aspects of the hiring process (e.g., application review or resume screening). These tools assist our team but do not replace human decision-making. All final hiring decisions are made by people.", "summaryDescription" : "Benefits and Wellbeing Manager at Woodard & Curran", "postedDate" : "2026-06-12T20:32:59.141", "createdAt" : "2026-06-12T20:32:59.141", "lastUpdated" : "2026-06-16T01:06:50.187", "ingestTimestamp" : "2026-06-14T21:40:37.306", "mongoId" : "6a2ce99574d8ee00a0a6e34e", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 100000, "salaryAnnualMax" : 195000, "salaryBand" : "100k-150k", "hasSalary" : true, "allSkills" : [ "Program management", "Employee benefits", "Wellness programs", "ERISA", "ACA", "CEBS certification preferred" ], "skillCount" : 6, "jobCategory" : "operations", "jobSubcategory" : "hr", "seniorityLevel" : "Manager", "dataQualityScore" : 1.0, "daysOld" : 3, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Engineering", "llmIndustryConfidence" : 0.98 }, { "id" : "69f9b8024c40e2acd1113f75", "title" : "WHS Regulatory Response Case Manager, Governance and External Affairs", "company" : "Amazon.com Services LLC", "industry" : "Corporate Operations, Risk Family, Logistics", "salary" : { "min" : 74200.0, "max" : 129800.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : false }, "location" : "Arlington, Virginia, USA", "locations" : [ "Arlington, Virginia, USA" ], "certifications" : [ "Professional auditing qualification" ], "timestamp" : "2026-06-15T07:26:26.424", "fingerprint" : "a9ef2d54ba4344b7e46b732a0c1f34fae4fb0695dd3dcaf1dbcb028163c98c71", "source" : "amazon", "language" : "en", "applyUrl" : "https://account.amazon.jobs/jobs/10410963/apply", "externalId" : "2edfaf1e-9106-4749-abdf-4b8cea497b6b", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Arlington", "state" : "Virginia", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "38.8769326,-77.0893094" } ], "locationText" : "Arlington, Virginia, United States", "employmentType" : "FULL_TIME", "minimumEducation" : "Bachelor's", "experienceMinYears" : 5, "experienceLevel" : "Manager", "technicalSkills" : "SQL, Excel", "professionalSkills" : [ "Regulatory compliance", "Case management", "Risk mitigation", "Process implementation" ], "hardSkillsList" : [ "Regulatory response", "Governance frameworks", "Policy development", "Procedure development", "Case assessment", "Control implementation", "Risk analysis", "Trend analysis" ], "hardSkills" : [ { "name" : "Regulatory response", "level" : "intermediate" }, { "name" : "Governance frameworks", "level" : "intermediate" }, { "name" : "Policy development", "level" : "intermediate" }, { "name" : "Procedure development", "level" : "intermediate" }, { "name" : "Case assessment", "level" : "intermediate" }, { "name" : "Control implementation", "level" : "intermediate" }, { "name" : "Risk analysis", "level" : "intermediate" }, { "name" : "Trend analysis", "level" : "intermediate" } ], "majorSkills" : "WHS governance, Regulatory response, Case management", "majorSkillsList" : [ "WHS governance", "Regulatory response", "Case management" ], "coreResponsibilities" : "Develop WHS governance frameworks, Maintain WHS governance frameworks, Develop WHS policies, Maintain WHS policies, Develop WHS procedures, Maintain WHS procedures, Lead case assessment processes, Implement control measures, Manage WHS regulatory cases, Analyze WHS data, Analyze WHS trends, Provide expert advice, Coordinate with stakeholders, Conduct regular audits, Review WHS systems, Review WHS processes", "teamCollaboration" : "Coordinate with stakeholders", "domainKnowledge" : "Workplace Health & Safety; High-risk operations regulations; Canadian regulations", "domainList" : [ "workplace-health-safety", "high-risk-operations-regulations", "canadian-regulations" ], "domainSpecificKnowledge" : [ "Workplace Health & Safety", "High-risk operations regulations", "Canadian regulations" ], "documentationSkills" : "Regulatory filings; Regulatory reports", "problemSolvingSkills" : "Risk mitigation", "qualificationsBasic" : "5+ years compliance program management, 5+ years legal experience, 5+ years governance experience, 5+ years audit experience, 5+ years risk/loss prevention experience, Experience handling confidential information, Experience with regulatory filings, Experience with regulatory reports", "qualificationsPreferred" : "3+ years program requirements definition, 3+ years data and metrics leveraging, Professional auditing qualification, Risk credentials, Compliance credentials", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "Amazon is seeking an experienced Workplace Health & Safety (WHS) professional to join the Governance Regulatory Response and Activity (RRA) team who will be responsible for regulatory response case managing. This role combines strategic planning with practical implementation to ensure regulatory compliance and promote a safety-first culture of all Amazon operations in North America. A strong background in health and safety management is required, specifically in regulations governing high-risk operations. Experience in varying Amazon operations and business unit processes is needed. Canadian experience is a plus. Key job responsibilities - Develop and maintain WHS governance frameworks, policies, and procedures aligned with current legislation and industry’s best practices - Lead case assessment processes and implement control measures across various operational areas - Manage complex WHS regulatory cases, including external agency investigations, associate claims and complaints, and execution of programs and procedures. - Analyze WHS data and trends to identify emerging risks and opportunities for improvement - Provide expert advice to senior management on WHS matters and risk mitigation strategies - Coordinate with stakeholders to ensure effective implementation of WHS initiatives - Conduct regular audits and reviews of WHS systems and processes Basic Qualifications: - 5+ years of compliance program management, legal, governance, audit, risk/loss prevention, or equivalent experience - Experience handling confidential information - Experience with regulatory filings and reports or equivalent - Bachelor's degree or above Preferred Qualifications: - 3+ years of program requirements definition and data and metrics leveraging to drive improvements experience - Professional auditing qualification, or similar risk or compliance credentials - Experience with SQL and Excel Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner. The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at https://amazon.jobs/en/benefits . USA, TN, Nashville - 66,800.00 - 116,800.00 USD annually USA, VA, Arlington - 74,200.00 - 129,800.00 USD annually USA, WA, Bellevue - 82,700.00 - 129,800.00 USD annually", "summaryDescription" : "WHS Regulatory Response Case Manager, Governance and External Affairs at Amazon.com Services LLC. Skills: WHS governance, Regulatory response, Case management. Develop WHS governance frameworks. Maintain WHS governance frameworks", "postedDate" : "2026-06-13T19:35:26.277", "createdAt" : "2026-06-13T19:35:26.277", "lastUpdated" : "2026-06-15T07:26:26.424", "ingestTimestamp" : "2026-06-13T19:35:26.277", "mongoId" : "69f9b8024c40e2acd1113f75", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "sourceUrl" : "https://account.amazon.jobs/jobs/10410963/apply", "salaryAnnualMin" : 74200, "salaryAnnualMax" : 129800, "salaryBand" : "50k-75k", "hasSalary" : true, "allSkills" : [ "Regulatory response", "Governance frameworks", "Policy development", "Procedure development", "Case assessment", "Control implementation", "Risk analysis", "Trend analysis", "WHS governance", "Case management", "Regulatory compliance", "Risk mitigation", "Process implementation", "Workplace Health & Safety", "High-risk operations regulations", "Canadian regulations", "Professional auditing qualification" ], "skillCount" : 17, "jobCategory" : "operations", "jobSubcategory" : "general", "seniorityLevel" : "Senior", "dataQualityScore" : 1.0, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "E-Commerce", "llmIndustryConfidence" : 0.95 }, { "id" : "6a2cd70174d8ee00a0a3ff7b", "title" : "Grants Project Manager (Canada)", "company" : "Climate Finance Solutions", "industry" : "Grants Management", "salary" : { "min" : 95.0, "max" : 135.0, "currency" : "CAD", "frequency" : "yearly", "is_estimated" : false }, "location" : "Climate Finance Solutions HQ", "locations" : [ "Climate Finance Solutions HQ" ], "certifications" : [ "PMP", "CRA", "CCRP" ], "timestamp" : "2026-06-15T21:19:04.345", "fingerprint" : "451be1dc2d3a8b06086e5e56d57c614e1c1d73a913056e452e6daffe4b0f88ea", "source" : "ashby", "language" : "en", "applyUrl" : "https://jobs.ashbyhq.com/climate-finance-solutions/f2558a32-53e7-4dce-b120-5d4dd127f65c/application", "externalId" : "f2558a32-53e7-4dce-b120-5d4dd127f65c", "industryFunction" : { }, "structuredLocations" : [ { "country" : "Canada", "continent" : "na", "workMode" : "remote" } ], "locationText" : "Canada", "employmentType" : "CONTRACT", "minimumEducation" : "Bachelor's", "experienceMinYears" : 6, "experienceLevel" : "Manager", "technicalSkills" : "Asana, Google Workspace, Microsoft Office", "professionalSkills" : [ "Project management", "Grant writing", "Stakeholder management", "Timeline development", "Compliance management", "Partnership development", "Proposal development" ], "hardSkillsList" : [ "Grant application management", "Federal grant compliance", "Program-specific terms management", "Submission management" ], "hardSkills" : [ { "name" : "Grant application management", "level" : "intermediate" }, { "name" : "Federal grant compliance", "level" : "intermediate" }, { "name" : "Program-specific terms management", "level" : "intermediate" }, { "name" : "Submission management", "level" : "intermediate" } ], "majorSkills" : "Grant project management, Federal grant applications, Client relations", "majorSkillsList" : [ "Grant project management", "Federal grant applications", "Client relations" ], "coreResponsibilities" : "Manage grant applications from client kickoff through submission, Ensure compliance with all requirements and deadlines, Develop project timelines, milestones, and go/no-go decision points, Create project tasks assigned to team members, Serve as primary point of contact between CFS, Provide weekly status updates on project status, Provide weekly updates on pending action items, Coordinate writers and technical experts across proposal teams, Balance expertise with capacity to avoid burnout, Oversee compliance with Canadian federal grant regulations, Oversee compliance with program-specific terms, Manage submissions across federal and provincial grant platforms, Serve as strategic advisor to client teams on, Serve as strategic advisor to client teams on, Shape applications to maximize funding outcomes, Coordinate cross-functionally between CFS team members, Coordinate cross-functionally with external partners, Ensure smooth proposal development and submission", "teamCollaboration" : "Cross-functional teams; External partners; Client teams", "projectManagementSkills" : [ "Project timelines", "Milestones", "Go/no-go decision points", "Task assignment", "Compliance", "Submission management" ], "domainKnowledge" : "Climate solutions; Canadian federal grant regulations; Program-specific terms; Policy on Transfer Payments; Climate-focused agencies; Renewable energy; Carbon management; Energy storage; Industrial decarbonization; Critical minerals; Hydrogen; Clean fuels; Grid technologies; Transportation; Sustainable agriculture; Advanced manufacturing; Nuclear energy", "domainList" : [ "climate-solutions", "canadian-federal-grant-regulations", "program-specific-terms", "policy-on-transfer-payments", "climate-focused-agencies", "renewable-energy", "carbon-management", "energy-storage", "industrial-decarbonization", "critical-minerals", "hydrogen", "clean-fuels", "grid-technologies", "transportation", "sustainable-agriculture", "advanced-manufacturing", "nuclear-energy" ], "domainSpecificKnowledge" : [ "Climate solutions", "Canadian federal grant regulations", "Program-specific terms", "Policy on Transfer Payments", "Climate-focused agencies", "Renewable energy", "Carbon management", "Energy storage", "Industrial decarbonization", "Critical minerals", "Hydrogen", "Clean fuels", "Grid technologies", "Transportation", "Sustainable agriculture", "Advanced manufacturing", "Nuclear energy" ], "toolProficiency" : [ "Asana", "Google Workspace", "Microsoft Office" ], "communicationSkills" : "Written communication; Oral communication; Status updates", "problemSolvingSkills" : "Analytical skills; Problem-solving abilities", "specialRequirements" : "Work fully remotely, Intercontinental teams and clients", "outcomesObjectives" : "Maximize funding outcomes", "qualificationsBasic" : "Bachelor's degree (or international equivalent), Fluency in English, Minimum of six years of grant project management or grant writing, At least three years as lead project manager on funded grant proposals, Scientific or technical knowledge relevant to climate solutions, Experience managing applications to climate-focused federal and provincial agencies, Knowledge of Canadian federal grant compliance, Working knowledge of Canadian federal and provincial grant submission platforms, Proficiency in Asana, Google Workspace, Microsoft Office, Oral and written communication skills, Detail-oriented with analytical and problem-solving abilities, Exceptional organizational and time management skills, Ability to work independently in a fast-paced startup environment, Flexibility and temperament required to work fully remotely, Weekday availability to check and respond to project communications, Mission-driven, with a clear understanding of the urgency of addressing the climate crisis", "qualificationsPreferred" : "Graduate degree, particularly in a related field, Bilingual writing capability (English and French), Experience with Quebec-based or French-language funding programs, Prior grant writing experience, Multi-platform experience with grant submission platforms", "remoteFriendly" : true, "workSiteFlexibility" : "Remote", "rawDescription" : "ABOUT CFS Climate Finance Solutions (CFS) is a global consultancy that helps companies and organizations secure large-scale grant funding for climate solutions. To date, our team has secured over $1.6 billion in non-dilutive funding for clients across Canada, the US, Europe, Australia, and emerging markets worldwide. As a mission-driven company, we are committed to providing equitable access to the climate funding ecosystem and building the next generation of leaders in climate finance. ABOUT THE ROLE As a Grants Project Manager, Canada at CFS, you’ll own federal and provincial grant applications end-to-end, leading writing teams and managing complex multi-stakeholder timelines, while serving as the strategic interface between CFS and our clients. You’ll bring rigor and momentum to high-stakes proposals from kickoff through submission, with quality and competitive positioning as the priority. We’re a fast-paced, fully remote team. Contractors who deliver consistently are considered for our Senior Project Manager role. KEY RESPONSIBILITIES • Manage grant applications from client kickoff through submission, ensuring compliance with all requirements and deadlines • Develop project timelines, milestones, and go/no-go decision points aligned with solicitation requirements, and create project tasks assigned to the appropriate team members • Serve as the primary point of contact between CFS and the client/partners, providing weekly status updates on project status and pending action items • Coordinate writers and technical experts across proposal teams, balancing expertise with capacity to avoid burnout • Oversee compliance with Canadian federal grant regulations and program-specific terms and conditions; manage submissions across federal and provincial grant platforms • Serve as a strategic advisor to client teams on competitive positioning and partnership development, helping shape applications to maximize funding outcomes • Coordinate cross-functionally between CFS team members and external partners to ensure smooth proposal development and submission QUALIFICATIONS Required • Bachelor’s degree (or international equivalent) • Fluency in English • Minimum of six years of grant project management or grant writing experience; at least three years as lead project manager on funded grant proposals • Strong scientific or technical knowledge relevant to climate solutions • Experience managing applications to climate-focused federal and provincial agencies, including, but not limited to, Natural Resources Canada (NRCan), Sustainable Development Technology Canada (SDTC), the Industrial Research Assistance Program (IRAP), the Strategic Response Fund (SRF), Environment and Climate Change Canada (ECCC), Alberta Innovates, Investissement Québec, and CleanBC • Strong knowledge of Canadian federal grant compliance, including Treasury Board of Canada policies, the Policy on Transfer Payments, and applicable program-specific terms and conditions • Working knowledge of Canadian federal and provincial grant submission platforms (which vary by program and agency); multi-platform experience is a plus • Proficiency in Asana, Google Workspace, Microsoft Office, and other standard project management and collaborative platforms • Strong oral and written communication skills for working cooperatively with internal teams, clients, and external partners • Detail-oriented with strong analytical and problem-solving abilities • Exceptional organizational and time management skills, with the ability to work independently in a fast-paced startup environment • Equipment, technical ability, flexibility, and temperament required to work fully remotely with intercontinental teams and clients, including weekday availability to check and respond to project communications • Mission-driven, with a clear understanding of the urgency of addressing the climate crisis Preferred • Graduate degree, particularly in a related field (business administration, public administration, or a scientific or technical field) • Prior grant writing experience • Bilingual writing capability (English and French) and experience with Quebec-based or French-language funding programs • Knowledge of climate sectors, including renewable energy, carbon management, energy storage/batteries, industrial decarbonization, critical minerals and materials, hydrogen and other clean fuels, grid technologies, transportation, sustainable agriculture, advanced manufacturing, nuclear, and more • Pre-award research administration, grant management, or project management certification (e.g., PMP, CRA, CCRP) OUR COMMITMENT TO INCLUSIVITY Climate Finance Solutions values diversity and is committed to fostering an equitable and inclusive environment. We firmly believe that a broad range of perspectives, backgrounds, and experiences is essential for addressing the complex challenges of climate change. We promote climate and social justice through our climate projects and within our own team. We especially encourage members of traditionally underrepresented communities (including women/non-male folks, people of color, LGBTQ+ people, veterans, Indigenous people, and people with disabilities) to apply to positions within the company. CFS is a member company of Empowering Diversity in Clean Tech (EDICT). COMPENSATION: $95-135 CAD / $70-100 USD per hour, commensurate with experience Position Type: Contractor Location: Remote/Canada", "summaryDescription" : "Grants Project Manager (Canada) at Climate Finance Solutions. Skills: Grant project management, Federal grant applications, Client relations. Manage grant applications from client kickoff through submission. Ensure compliance with all requirements and deadlines", "createdAt" : "2026-06-14T20:19:28.643", "lastUpdated" : "2026-06-15T21:19:04.345", "ingestTimestamp" : "2026-06-14T20:19:28.643", "mongoId" : "6a2cd70174d8ee00a0a3ff7b", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "<30k", "hasSalary" : false, "allSkills" : [ "Grant application management", "Federal grant compliance", "Program-specific terms management", "Submission management", "Grant project management", "Federal grant applications", "Client relations", "Project management", "Grant writing", "Stakeholder management", "Timeline development", "Compliance management", "Partnership development", "Proposal development", "Project timelines", "Milestones", "Go/no-go decision points", "Task assignment", "Compliance", "Climate solutions", "Canadian federal grant regulations", "Program-specific terms", "Policy on Transfer Payments", "Climate-focused agencies", "Renewable energy", "Carbon management", "Energy storage", "Industrial decarbonization", "Critical minerals", "Hydrogen", "Clean fuels", "Grid technologies", "Transportation", "Sustainable agriculture", "Advanced manufacturing", "Nuclear energy", "PMP", "CRA", "CCRP", "Asana", "Google Workspace", "Microsoft Office" ], "skillCount" : 42, "jobCategory" : "operations", "jobSubcategory" : "general", "seniorityLevel" : "Senior", "dataQualityScore" : 0.8888889, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Climate Tech", "llmIndustryConfidence" : 0.95 }, { "id" : "6a307466f292fd229c0067d4", "title" : "Manager, Corporate Legal Affairs", "company" : "NBCUniversal", "industry" : "Entertainment", "salary" : { "min" : 80000.0, "max" : 100000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : false }, "location" : "Universal City, CA, United States", "locations" : [ "Universal City", "CA", "United States" ], "timestamp" : "2026-06-16T12:14:31.166", "fingerprint" : "3905a3366446b1c1e8ac4a896146ea4f33e725bba4090544805a03e76e97c123", "source" : "smartrecruiters", "language" : "en", "applyUrl" : "https://jobs.smartrecruiters.com/NBCUniversal3/744000132274979-manager-corporate-legal-affairs", "externalId" : "744000132274979", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Universal City", "state" : "California", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "hybrid", "geo" : "34.1419225,-118.3584110" }, { "city" : "Washington", "state" : "District of Columbia", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "hybrid", "geo" : "38.8950982,-77.0363849" }, { "city" : "New York", "state" : "New York", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "hybrid", "geo" : "40.7127281,-74.0060152" } ], "locationText" : "Universal City, California, United States; Washington, District of Columbia, United States; New York, New York, United States", "employmentType" : "FULL_TIME", "experienceMinYears" : 5, "experienceMaxYears" : 10, "experienceLevel" : "mid", "professionalSkills" : [ "Contract negotiation", "Litigation management", "Intellectual property", "Employment law", "Corporate governance", "Legal analysis", "Risk management", "Compliance oversight" ], "hardSkillsList" : [ "Contract drafting", "Legal research", "Regulatory compliance" ], "hardSkills" : [ { "name" : "Contract drafting", "level" : "intermediate" }, { "name" : "Legal research", "level" : "intermediate" }, { "name" : "Regulatory compliance", "level" : "intermediate" } ], "majorSkills" : "Legal affairs, Corporate governance, Contract negotiation", "majorSkillsList" : [ "Legal affairs", "Corporate governance", "Contract negotiation" ], "coreResponsibilities" : "Manage corporate legal affairs, Provide legal counsel, Oversee contract negotiation, Manage litigation, Advise on intellectual property, Advise on employment law, Advise on corporate governance, Ensure regulatory compliance, Conduct legal analysis, Manage legal risks", "teamCollaboration" : "Cross-functional teams; Business units", "domainKnowledge" : "Intellectual property law; Employment law; Corporate governance; Contract law; Litigation procedures; Regulatory requirements", "domainList" : [ "intellectual-property-law", "employment-law", "corporate-governance", "contract-law", "litigation-procedures", "regulatory-requirements" ], "domainSpecificKnowledge" : [ "Intellectual property law", "Employment law", "Corporate governance", "Contract law", "Litigation procedures", "Regulatory requirements" ], "communicationSkills" : "Legal counsel; Business unit advice", "documentationSkills" : "Contract drafting", "problemSolvingSkills" : "Legal analysis; Risk management", "qualificationsBasic" : "Bachelor's degree, 5+ years relevant experience, Experience with contract negotiation, Experience with litigation management, Experience with intellectual property, Experience with employment law, Experience with corporate governance", "qualificationsPreferred" : "JD degree preferred, Admission to a state bar preferred", "remoteFriendly" : false, "workSiteFlexibility" : "Flexible", "rawDescription" : "NBCUniversal is one of the world's leading media and entertainment companies. We create world-class content, which we distribute across our portfolio of film, television, and streaming, and bring to life through our global theme park destinations, consumer products, and experiences. We own and operate leading entertainment and news brands, including NBC, NBC News, NBC Sports, Telemundo, NBC Local Stations, Bravo, and Peacock, our premium ad-supported streaming service. We produce and distribute premier filmed entertainment and programming through our powerhouse film and television studios, including Universal Pictures, DreamWorks Animation, and Focus Features, and the four global television studios under the Universal Studio Group banner, and operate industry-leading theme parks and experiences around the world through Universal Destinations & Experiences, including Universal Orlando Resort, home to Universal Epic Universe, and Universal Studios Hollywood. NBCUniversal is a subsidiary of Comcast Corporation. Visit www.nbcuniversal.com for more information. Our impact is rooted in improving the communities where our employees, customers, and audiences live and work. We have a rich tradition of giving back and ensuring our employees have the opportunity to serve their communities. We champion an inclusive culture and strive to attract and develop a talented workforce to create and deliver a wide range of content reflecting our world. NBCUniversal is seeking a Manager, Corporate Legal Affairs (Corporate Secretary) to support corporate governance, legal entity management, and compliance for its U.S. and Canadian subsidiaries. This role sits within a high-impact Corporate Secretary team that serves as the central resource for legal entity formation, governance, and compliance across NBCUniversal’s global portfolio of businesses. The ideal candidate will be a detail-oriented and collaborative professional who can manage a high volume of corporate governance activities, maintain data integrity across enterprise systems, and partner effectively with Legal, Tax, Finance, and external service providers. This role is ideal for a strong corporate paralegal or governance professional looking to step into a broader, enterprise-facing position with meaningful ownership over legal entity operations and governance. Here you can: Corporate Governance & Secretarial Support * Provide corporate secretarial support for U.S. and Canadian entities, including: * Drafting secretary certificates and corporate certifications * Preparing written consents, resolutions, and governance documentation * Maintain corporate digital minute books, ensuring completeness and accuracy * Coordinate with outside counsel on governance matters relating to Canadian entities Legal Entity Compliance & Filings * Prepare and file annual reports and other statutory filings to maintain entities in good standing * Track and manage compliance deadlines across a large portfolio of entities * Support regulatory filings and responses to governmental or compliance-related inquiries * Provide corporate support in connection with litigation, arbitration, and regulatory matters Legal Entity Data & Systems * Manage and maintain the corporate legal entity database, the enterprise system of record for legal entity data * Ensure timely and accurate updates to ownership, governance, and structural data * Generate organizational charts and entity reports for internal stakeholders * Partner on system initiatives, including enhancements and data integrity efforts Operations & Vendor Management * Oversee billing and invoicing for key corporate secretarial vendors in coordination with global counterparts * Review and process filing expenses and vendor invoices to ensure timely payment Cross-Functional Collaboration * Serve as a key resource to Legal and business teams on matters relating to: * Corporate governance * Legal entity structure * Execution of corporate actions * Support entity formations, restructurings, and dissolutions by coordinating required governance documentation * Assist with corporate documentation required by internal stakeholders and external regulators Scope * Primary responsibility for NBCUniversal’s U.S. and Canadian legal entities * Works closely with global Corporate Secretary team members across Europe and other jurisdictions ## Qualifications Here you'll need: * 4+ years of experience in corporate governance, corporate secretary, or legal entity management * Strong knowledge of U.S. corporate governance and compliance requirements * Experience managing corporate filings, minute books, and legal entity records * Experience working with legal entity management systems preferred What we'll look for: * Highly detail-oriented with strong organizational and project management skills * Ability to manage competing priorities in a fast-paced, global environment This position currently has a hybrid schedule, which requires contributing from the New York, NY or Universal City, CA office a minimum of four days per week. The Company reserves the right to change in-office requirements at any time. This position is eligible for company sponsored benefits, including medical, dental and vision insurance, 401(k), paid leave, tuition reimbursement, and a variety of other discounts and perks. Learn more about the benefits offered by NBCUniversal by visiting the Benefits page of the Careers website. Salary range: $80,000-$100,000 (bonus eligible) ## Additional Information As part of our selection process, external candidates may be required to attend an in-person interview with an NBCUniversal employee at one of our locations prior to a hiring decision. NBCUniversal's policy is to provide equal employment opportunities to all applicants and employees without regard to race, color, religion, creed, gender, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law. NBCUniversal will consider for employment qualified applicants with criminal histories, or arrest or conviction records, in a manner consistent with relevant legal requirements, including the City of Los Angeles' Fair Chance Initiative For Hiring Ordinance, the Los Angeles County Fair Chance Ordinance for Employers, and the California Fair Chance Act, where applicable. If you are a qualified individual with a disability or a disabled veteran and require support throughout the application and/or recruitment process as a result of your disability, you have the right to request a reasonable accommodation. You can submit your request to AccessibilitySupport@nbcuni.com.", "summaryDescription" : "Manager, Corporate Legal Affairs at NBCUniversal. Skills: Legal affairs, Corporate governance, Contract negotiation. Manage corporate legal affairs. 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We create world-class content, which we distribute across our portfolio of film, television, and streaming, and bring to life through our global theme park destinations, consumer products, and experiences. We own and operate leading entertainment and news brands, including NBC, NBC News, NBC Sports, Telemundo, NBC Local Stations, Bravo, and Peacock, our premium ad-supported streaming service. We produce and distribute premier filmed entertainment and programming through our powerhouse film and television studios, including Universal Pictures, DreamWorks Animation, and Focus Features, and the four global television studios under the Universal Studio Group banner, and operate industry-leading theme parks and experiences around the world through Universal Destinations & Experiences, including Universal Orlando Resort, home to Universal Epic Universe, and Universal Studios Hollywood. NBCUniversal is a subsidiary of Comcast Corporation. Visit www.nbcuniversal.com for more information. Our impact is rooted in improving the communities where our employees, customers, and audiences live and work. We have a rich tradition of giving back and ensuring our employees have the opportunity to serve their communities. We champion an inclusive culture and strive to attract and develop a talented workforce to create and deliver a wide range of content reflecting our world. NBCUniversal is seeking a Manager, Corporate Legal Affairs (Corporate Secretary) to support corporate governance, legal entity management, and compliance for its U.S. and Canadian subsidiaries. This role sits within a high-impact Corporate Secretary team that serves as the central resource for legal entity formation, governance, and compliance across NBCUniversal’s global portfolio of businesses. The ideal candidate will be a detail-oriented and collaborative professional who can manage a high volume of corporate governance activities, maintain data integrity across enterprise systems, and partner effectively with Legal, Tax, Finance, and external service providers. This role is ideal for a strong corporate paralegal or governance professional looking to step into a broader, enterprise-facing position with meaningful ownership over legal entity operations and governance. Here you can: Corporate Governance & Secretarial Support * Provide corporate secretarial support for U.S. and Canadian entities, including: * Drafting secretary certificates and corporate certifications * Preparing written consents, resolutions, and governance documentation * Maintain corporate digital minute books, ensuring completeness and accuracy * Coordinate with outside counsel on governance matters relating to Canadian entities Legal Entity Compliance & Filings * Prepare and file annual reports and other statutory filings to maintain entities in good standing * Track and manage compliance deadlines across a large portfolio of entities * Support regulatory filings and responses to governmental or compliance-related inquiries * Provide corporate support in connection with litigation, arbitration, and regulatory matters Legal Entity Data & Systems * Manage and maintain the corporate legal entity database, the enterprise system of record for legal entity data * Ensure timely and accurate updates to ownership, governance, and structural data * Generate organizational charts and entity reports for internal stakeholders * Partner on system initiatives, including enhancements and data integrity efforts Operations & Vendor Management * Oversee billing and invoicing for key corporate secretarial vendors in coordination with global counterparts * Review and process filing expenses and vendor invoices to ensure timely payment Cross-Functional Collaboration * Serve as a key resource to Legal and business teams on matters relating to: * Corporate governance * Legal entity structure * Execution of corporate actions * Support entity formations, restructurings, and dissolutions by coordinating required governance documentation * Assist with corporate documentation required by internal stakeholders and external regulators Scope * Primary responsibility for NBCUniversal’s U.S. and Canadian legal entities * Works closely with global Corporate Secretary team members across Europe and other jurisdictions ## Qualifications Here you'll need: * 4+ years of experience in corporate governance, corporate secretary, or legal entity management * Strong knowledge of U.S. corporate governance and compliance requirements * Experience managing corporate filings, minute books, and legal entity records * Experience working with legal entity management systems preferred What we'll look for: * Highly detail-oriented with strong organizational and project management skills * Ability to manage competing priorities in a fast-paced, global environment This position currently has a hybrid schedule, which requires contributing from the New York, NY or Universal City, CA office a minimum of four days per week. The Company reserves the right to change in-office requirements at any time. This position is eligible for company sponsored benefits, including medical, dental and vision insurance, 401(k), paid leave, tuition reimbursement, and a variety of other discounts and perks. Learn more about the benefits offered by NBCUniversal by visiting the Benefits page of the Careers website. Salary range: $80,000-$100,000 (bonus eligible) ## Additional Information As part of our selection process, external candidates may be required to attend an in-person interview with an NBCUniversal employee at one of our locations prior to a hiring decision. NBCUniversal's policy is to provide equal employment opportunities to all applicants and employees without regard to race, color, religion, creed, gender, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law. NBCUniversal will consider for employment qualified applicants with criminal histories, or arrest or conviction records, in a manner consistent with relevant legal requirements, including the City of Los Angeles' Fair Chance Initiative For Hiring Ordinance, the Los Angeles County Fair Chance Ordinance for Employers, and the California Fair Chance Act, where applicable. If you are a qualified individual with a disability or a disabled veteran and require support throughout the application and/or recruitment process as a result of your disability, you have the right to request a reasonable accommodation. You can submit your request to AccessibilitySupport@nbcuni.com.", "summaryDescription" : "Manager, Corporate Legal Affairs at NBCUniversal. Skills: Legal affairs, Compliance, Risk management. Provide legal counsel. 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We create world-class content, which we distribute across our portfolio of film, television, and streaming, and bring to life through our global theme park destinations, consumer products, and experiences. We own and operate leading entertainment and news brands, including NBC, NBC News, NBC Sports, Telemundo, NBC Local Stations, Bravo, and Peacock, our premium ad-supported streaming service. We produce and distribute premier filmed entertainment and programming through our powerhouse film and television studios, including Universal Pictures, DreamWorks Animation, and Focus Features, and the four global television studios under the Universal Studio Group banner, and operate industry-leading theme parks and experiences around the world through Universal Destinations & Experiences, including Universal Orlando Resort, home to Universal Epic Universe, and Universal Studios Hollywood. NBCUniversal is a subsidiary of Comcast Corporation. Visit www.nbcuniversal.com for more information. Our impact is rooted in improving the communities where our employees, customers, and audiences live and work. We have a rich tradition of giving back and ensuring our employees have the opportunity to serve their communities. We champion an inclusive culture and strive to attract and develop a talented workforce to create and deliver a wide range of content reflecting our world. NBCUniversal is seeking a Manager, Corporate Legal Affairs (Corporate Secretary) to support corporate governance, legal entity management, and compliance for its U.S. and Canadian subsidiaries. This role sits within a high-impact Corporate Secretary team that serves as the central resource for legal entity formation, governance, and compliance across NBCUniversal’s global portfolio of businesses. The ideal candidate will be a detail-oriented and collaborative professional who can manage a high volume of corporate governance activities, maintain data integrity across enterprise systems, and partner effectively with Legal, Tax, Finance, and external service providers. This role is ideal for a strong corporate paralegal or governance professional looking to step into a broader, enterprise-facing position with meaningful ownership over legal entity operations and governance. Here you can: Corporate Governance & Secretarial Support * Provide corporate secretarial support for U.S. and Canadian entities, including: * Drafting secretary certificates and corporate certifications * Preparing written consents, resolutions, and governance documentation * Maintain corporate digital minute books, ensuring completeness and accuracy * Coordinate with outside counsel on governance matters relating to Canadian entities Legal Entity Compliance & Filings * Prepare and file annual reports and other statutory filings to maintain entities in good standing * Track and manage compliance deadlines across a large portfolio of entities * Support regulatory filings and responses to governmental or compliance-related inquiries * Provide corporate support in connection with litigation, arbitration, and regulatory matters Legal Entity Data & Systems * Manage and maintain the corporate legal entity database, the enterprise system of record for legal entity data * Ensure timely and accurate updates to ownership, governance, and structural data * Generate organizational charts and entity reports for internal stakeholders * Partner on system initiatives, including enhancements and data integrity efforts Operations & Vendor Management * Oversee billing and invoicing for key corporate secretarial vendors in coordination with global counterparts * Review and process filing expenses and vendor invoices to ensure timely payment Cross-Functional Collaboration * Serve as a key resource to Legal and business teams on matters relating to: * Corporate governance * Legal entity structure * Execution of corporate actions * Support entity formations, restructurings, and dissolutions by coordinating required governance documentation * Assist with corporate documentation required by internal stakeholders and external regulators Scope * Primary responsibility for NBCUniversal’s U.S. and Canadian legal entities * Works closely with global Corporate Secretary team members across Europe and other jurisdictions ## Qualifications Here you'll need: * 4+ years of experience in corporate governance, corporate secretary, or legal entity management * Strong knowledge of U.S. corporate governance and compliance requirements * Experience managing corporate filings, minute books, and legal entity records * Experience working with legal entity management systems preferred What we'll look for: * Highly detail-oriented with strong organizational and project management skills * Ability to manage competing priorities in a fast-paced, global environment This position currently has a hybrid schedule, which requires contributing from the New York, NY or Universal City, CA office a minimum of four days per week. The Company reserves the right to change in-office requirements at any time. This position is eligible for company sponsored benefits, including medical, dental and vision insurance, 401(k), paid leave, tuition reimbursement, and a variety of other discounts and perks. Learn more about the benefits offered by NBCUniversal by visiting the Benefits page of the Careers website. Salary range: $80,000-$100,000 (bonus eligible) ## Additional Information As part of our selection process, external candidates may be required to attend an in-person interview with an NBCUniversal employee at one of our locations prior to a hiring decision. NBCUniversal's policy is to provide equal employment opportunities to all applicants and employees without regard to race, color, religion, creed, gender, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law. If you are a qualified individual with a disability or a disabled veteran and require support throughout the application and/or recruitment process as a result of your disability, you have the right to request a reasonable accommodation. You can submit your request to AccessibilitySupport@nbcuni.com.", "summaryDescription" : "Manager, Corporate Legal Affairs at NBCUniversal. Skills: Legal affairs, Compliance, Risk management. Provide legal counsel. 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We create world-class content, which we distribute across our portfolio of film, television, and streaming, and bring to life through our global theme park destinations, consumer products, and experiences. We own and operate leading entertainment and news brands, including NBC, NBC News, NBC Sports, Telemundo, NBC Local Stations, Bravo, and Peacock, our premium ad-supported streaming service. We produce and distribute premier filmed entertainment and programming through our powerhouse film and television studios, including Universal Pictures, DreamWorks Animation, and Focus Features, and the four global television studios under the Universal Studio Group banner, and operate industry-leading theme parks and experiences around the world through Universal Destinations & Experiences, including Universal Orlando Resort, home to Universal Epic Universe, and Universal Studios Hollywood. NBCUniversal is a subsidiary of Comcast Corporation. Visit www.nbcuniversal.com for more information. Our impact is rooted in improving the communities where our employees, customers, and audiences live and work. We have a rich tradition of giving back and ensuring our employees have the opportunity to serve their communities. We champion an inclusive culture and strive to attract and develop a talented workforce to create and deliver a wide range of content reflecting our world. NBCUniversal is seeking a Manager, Corporate Legal Affairs (Corporate Secretary) to support corporate governance, legal entity management, and compliance for its U.S. and Canadian subsidiaries. This role sits within a high-impact Corporate Secretary team that serves as the central resource for legal entity formation, governance, and compliance across NBCUniversal’s global portfolio of businesses. The ideal candidate will be a detail-oriented and collaborative professional who can manage a high volume of corporate governance activities, maintain data integrity across enterprise systems, and partner effectively with Legal, Tax, Finance, and external service providers. This role is ideal for a strong corporate paralegal or governance professional looking to step into a broader, enterprise-facing position with meaningful ownership over legal entity operations and governance. Here you can: Corporate Governance & Secretarial Support * Provide corporate secretarial support for U.S. and Canadian entities, including: * Drafting secretary certificates and corporate certifications * Preparing written consents, resolutions, and governance documentation * Maintain corporate digital minute books, ensuring completeness and accuracy * Coordinate with outside counsel on governance matters relating to Canadian entities Legal Entity Compliance & Filings * Prepare and file annual reports and other statutory filings to maintain entities in good standing * Track and manage compliance deadlines across a large portfolio of entities * Support regulatory filings and responses to governmental or compliance-related inquiries * Provide corporate support in connection with litigation, arbitration, and regulatory matters Legal Entity Data & Systems * Manage and maintain the corporate legal entity database, the enterprise system of record for legal entity data * Ensure timely and accurate updates to ownership, governance, and structural data * Generate organizational charts and entity reports for internal stakeholders * Partner on system initiatives, including enhancements and data integrity efforts Operations & Vendor Management * Oversee billing and invoicing for key corporate secretarial vendors in coordination with global counterparts * Review and process filing expenses and vendor invoices to ensure timely payment Cross-Functional Collaboration * Serve as a key resource to Legal and business teams on matters relating to: * Corporate governance * Legal entity structure * Execution of corporate actions * Support entity formations, restructurings, and dissolutions by coordinating required governance documentation * Assist with corporate documentation required by internal stakeholders and external regulators Scope * Primary responsibility for NBCUniversal’s U.S. and Canadian legal entities * Works closely with global Corporate Secretary team members across Europe and other jurisdictions ## Qualifications Here you'll need: * 4+ years of experience in corporate governance, corporate secretary, or legal entity management * Strong knowledge of U.S. corporate governance and compliance requirements * Experience managing corporate filings, minute books, and legal entity records * Experience working with legal entity management systems preferred What we'll look for: * Highly detail-oriented with strong organizational and project management skills * Ability to manage competing priorities in a fast-paced, global environment This position currently has a hybrid schedule, which requires contributing from the New York, NY or Universal City, CA office a minimum of four days per week. The Company reserves the right to change in-office requirements at any time. This position is eligible for company sponsored benefits, including medical, dental and vision insurance, 401(k), paid leave, tuition reimbursement, and a variety of other discounts and perks. Learn more about the benefits offered by NBCUniversal by visiting the Benefits page of the Careers website. Salary range: $80,000-$100,000 (bonus eligible) ## Additional Information As part of our selection process, external candidates may be required to attend an in-person interview with an NBCUniversal employee at one of our locations prior to a hiring decision. NBCUniversal's policy is to provide equal employment opportunities to all applicants and employees without regard to race, color, religion, creed, gender, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law. If you are a qualified individual with a disability or a disabled veteran and require support throughout the application and/or recruitment process as a result of your disability, you have the right to request a reasonable accommodation. You can submit your request to AccessibilitySupport@nbcuni.com.", "summaryDescription" : "Manager, Corporate Legal Affairs at NBCUniversal. Skills: Legal affairs, Compliance, Risk management. Provide legal counsel. Draft and review contracts", "postedDate" : "2026-06-15T19:44:23.000", "createdAt" : "2026-06-16T00:07:51.730", "lastUpdated" : "2026-06-16T10:35:28.622", "ingestTimestamp" : "2026-06-16T00:07:51.730", "mongoId" : "6a306afff292fd229cfceb50", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 80000, "salaryAnnualMax" : 100000, "salaryBand" : "75k-100k", "hasSalary" : true, "allSkills" : [ "Contract drafting", "Regulatory compliance", "Intellectual property law", "Litigation management", "Transactional law", "Legal affairs", "Compliance", "Risk management", "Legal analysis", "Compliance oversight", "Media law", "Intellectual property", "Litigation" ], "skillCount" : 13, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Manager", "dataQualityScore" : 1.0, "daysOld" : 0, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Media", "llmIndustryConfidence" : 0.98 }, { "id" : "6a2a60b574d8ee00a06204f4", "title" : "Head, Regulatory Affairs, General Medicine and Vaccines Canada", "company" : "Sanofi", "industry" : "Biopharma", "salary" : { "min" : 158200.0, "max" : 208200.0, "currency" : "CAD", "frequency" : "yearly", "is_estimated" : false }, "location" : "Toronto, ON", "locations" : [ "Toronto, ON", "Canada" ], "timestamp" : "2026-06-12T19:13:39.815", "fingerprint" : "70d658c936f0f7e9612c81c0483fd6eb94a2fb395853511432251f63bef522d6", "source" : "workday", "language" : "en", "applyUrl" : "https://sanofi.wd3.myworkdayjobs.com/SanofiCareers/job/Toronto-ON/Head--Regulatory-Affairs--General-Medicine-and-Vaccines-Canada_R2859308-1", "externalId" : "R2859308", "industryFunction" : { }, "locationPoint" : "-33.01357,151.59373", "structuredLocations" : [ { "city" : "Toronto", "state" : "Ontario", "country" : "Canada", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "43.6534817,-79.3839347" } ], "locationText" : "Toronto, Ontario, Canada", "employmentType" : "FULL_TIME", "experienceLevel" : "Manager", "professionalSkills" : [ "Regulatory strategy", "Project management", "Risk analysis", "Business development", "Change leadership", "Strategic thinking", "Operational thinking" ], "hardSkillsList" : [ "Regulatory affairs", "Regulatory compliance", "Clinical trial management", "Submission preparation", "Data management" ], "softSkillsList" : [ "Leadership", "Decision-making", "Negotiation" ], "hardSkills" : [ { "name" : "Regulatory affairs", "level" : "intermediate" }, { "name" : "Regulatory compliance", "level" : "intermediate" }, { "name" : "Clinical trial management", "level" : "intermediate" }, { "name" : "Submission preparation", "level" : "intermediate" }, { "name" : "Data management", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Leadership" }, { "name" : "Decision-making" }, { "name" : "Negotiation" } ], "majorSkills" : "Regulatory Affairs, Team Leadership, Health Canada Submissions", "majorSkillsList" : [ "Regulatory Affairs", "Team Leadership", "Health Canada Submissions" ], "coreResponsibilities" : "Provide leadership to regulatory professionals, Manage regulatory affairs activities, Oversee early approvals, Ensure regulatory compliance, Manage product lifecycle, Prepare regulatory dossiers, Submit regulatory dossiers to Health Canada, Respond to authority questions, Maintain commitments for product approvals, Evaluate business development opportunities, Assess regulatory strategy, Provide strategic direction, Ensure smooth daily operations, Develop scientific skills, Maintain awareness of regulatory trends, Review Health Canada guidelines, Provide comments on Health Canada policies, Implement departmental vision, Set individual priorities and goals, Provide constructive feedback, Provide coaching to direct reports, Facilitate employee development plans, Complete performance reviews, Implement personal development plan", "teamCollaboration" : "Business Unit leadership teams; RA Leadership team; Key corporate regulatory sites; Key opinion leaders; Industry advocacy groups", "projectManagementSkills" : [ "Project management" ], "domainKnowledge" : "General Medicine; Vaccines; Canadian regulatory requirements; EU regulatory trends; US regulatory trends", "domainList" : [ "general-medicine", "vaccines", "canadian-regulatory-requirements", "eu-regulatory-trends", "us-regulatory-trends" ], "domainSpecificKnowledge" : [ "General Medicine", "Vaccines", "Canadian regulatory requirements", "EU regulatory trends", "US regulatory trends" ], "documentationSkills" : "Regulatory filings", "continuousLearning" : "Personal development plan", "problemSolvingSkills" : "Risk analysis", "outcomesObjectives" : "Achieve shortest time to approval; Obtain best possible labelling", "qualificationsBasic" : "Minimum Bachelor’s degree in science, Degree in a health-related field, At least 5 years of experience in regulatory affairs, Extensive knowledge of the regulatory environment", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "**Reference no.****R2859308** **Position title:** Head, Regulatory Affairs, General Medicine and Vaccines Canada **Department:** Regulatory Affairs **Location:** Toronto, ON **About the job** As the Head, Regulatory Affairs, General Medicine and Vaccines Canada on our GRA NA team, you’ll be fully accountable to provide leadership to a team of regulatory professionals for regulatory affairs activities including early approvals and regulatory compliance activities throughout the entire product lifecycle for a portfolio of development and marketed prescription products. Ready to get started? Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. The primary purpose of this position is to provide leadership to a team of regulatory professionals for regulatory affairs activities including early approvals and regulatory compliance activities throughout the entire product lifecycle for a portfolio of development and marketed prescription products, as defined by Head, Regulatory Affairs. This position may also be a designated back-up to the Head, Regulatory Affairs. **About Sanofi** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. _**Our Team/ Overview:**_ The Canada Regulatory Affairs team is responsible for preparing and submitting regulatory dossiers to Health Canada to ensure regulatory compliance and obtain marketing authorizations for Sanofi's General Medicine, Specialty Care, and Vaccine portfolio products. The team serves as the direct point of contact with Health Canada, coordinating regulatory submissions, responding to authority questions, and maintaining commitments to support timely product approvals. **_Main Responsibilities:_** **1\\. Accountable for the activities of a team of professional level individuals, that cover a portfolio (as defined by Head, Regulatory Affairs) of development and marketed products –80-90% of allocated time** **a) Regulatory Activities and Resources –60% of allocated time** * Provide leadership and managerial support to submissions teams to ensure quality decisions and timely preparation of submissions to Health Canada in order to achieve the shortest time to approval and the best possible labelling. The portfolio supports products in the General Medicine and Vaccines Business units. * Ensure team maintains compliance (as per Global Regulatory Affairs performance timelines) to provision of current and accurate data in internal database systems * Evaluate business development opportunities in order to assess optimal regulatory strategy * Provide strategic direction and leadership in the management of clinical trial regulatory activities for defined portfolio * Participate in Business Unit (as assigned by Head, Regulatory Affairs) cross-functional leadership team(s) to ensure strategic leadership and contribution from regulatory affairs to core business activities * As part of RA Leadership team, assist Head, Regulatory Affairs in setting strategic direction for team and ensuring smooth daily operations _Regulatory Resources_ * Ensure and maintain visibility and excellence of the team within business units by developing good scientific skills in the core therapeutic areas * Maintain awareness and knowledge of new and emerging local and international (EU and US) regulatory trends as well as on basic regulatory quality Canadian requirements * Review and provide comments on Health Canada draft guidelines and policies. **b) Development of Human Capital – 20-30% of allocated time** _Direct Reports_ * Ensure implementation of departmental vision and strategies into individual priorities and goals * Provide constructive feedback and coaching to all direct reports on an ongoing basis to facilitate and enable the attainment of employees’ development plans * Complete performance review activities for all direct reports as per the established corporate guidelines and practices _Self-Development_ * Elaborate and implement a personal development plan that will allow for the attainment of personal goals and required competencies aligned to the corporate values and priorities **2\\. Networking (10-20%)** * Establish and maintain a network with the key corporate regulatory sites and business units to assure the successful execution and alignment of Canadian-specific strategies within an international corporate context * Develop, optimize and maintain a network with key partners including the Canadian regulatory authority and key opinion leaders and seize opportunities to negotiate improved regulatory processes with the Canadian authority * Act as Sanofi liaison to industry advocacy external groups such as BIOTECanada or Innovative Medicines Canada (IMC), as required **** **About You** _**Education:**_ * Minimum Bachelor’s degree in science or a degree in a health-related field _**Experience:**_ * At least 5 years of experience in regulatory affairs, as a project leader or in another related position and extensive knowledge of the regulatory environment _**Specific Skills / Knowledge:**_ * Leadership and managerial skills (strong decision-making, communication, project management and risk analysis skills) * Building effective teams * Developed change leadership skills (i.e., ability to cope with and adapt to change, effectively prioritize, and deal with ambiguity) * Strong strategic and operational thinking (i.e., able to think big picture balanced with strong analytical skills) * Excellent negotiation skills with demonstrated ability to manage and influence key stakeholders * Fosters innovation (i.e., embraces new insights, concepts, trends & processes) _**Languages:**_ * English (written and spoken) * French is an important asset _**Computer Knowledge:**_ * MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat * Veeva Vault database familiarity is an asset _**Travel:**_ * Occasionally **Why Choose Us?** * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs. **Pourquoi nous choisir ?** * Donnez vie aux miracles de la science au sein d'une équipe solidaire et tournée vers l'avenir * Découvrez les innombrables possibilités de développer vos talents et de faire progresser votre carrière, que ce soit par le biais d'une promotion ou d'une cooptation, dans votre pays ou à l'étranger. * Profitez d'un ensemble d’avantages bien pensés et bien conçus qui reconnaissent votre contribution et amplifient votre impact. * Prenez bien soin de vous et de votre famille en bénéficiant d’un large éventail d'avantages en matière de santé et de bien-être, y compris des soins de santé de haute qualité, des programmes de prévention et de bien-être \\ **AI Usage** \"Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal, [ _Data Subject Rights Webform_](https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fprivacyportal-eu.onetrust.com%2Fwebform%2Fdd85e611-5592-4331-b346-b8739f63f687%2Fa02f5bbc-d820-431e-8549-50e9994da67b&data=05%7C02%7CJeff.Cabador%40sanofi.com%7Cbea100e8d319434e663b08de4c73ab48%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C639032257274746703%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=T2Zyl1CLQ%2BSUgiVu5lCX5FFYw539%2B9ALHh5R%2BgnetsA%3D&reserved=0). The [ _Data Subject Rights Webform_](https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fprivacyportal-eu.onetrust.com%2Fwebform%2Fdd85e611-5592-4331-b346-b8739f63f687%2Fa02f5bbc-d820-431e-8549-50e9994da67b&data=05%7C02%7CJeff.Cabador%40sanofi.com%7Cbea100e8d319434e663b08de4c73ab48%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C639032257274783341%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=cUp34mNcCYNxMJddmbeD%2F8jdVc9mF7TXtV4DbsWC6sg%3D&reserved=0) can also be used to request access or correction of your personal information and file a complaint. Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. #GD-SA #LI-SA #LI-Onsite # Pursue _progress_ , discover _extraordinary_ Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our [ALL IN video](https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at [sanofi.com](https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness)! _North America Applicants Only_ The salary range for this position is: 158,200.00 - 208,200.00 (Includes target bonus) Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA)[LINK](https://myflex-benefits.ca/en/home/)OR (US) [LINK](https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi). La fourchette salariale pour ce poste est la suivante: 158,200.00 - 208,200.00 (Comprend le bonus cible) La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise, et des informations supplémentaires sur les avantages sociaux peuvent être trouvées via le [lien](https://myflex-benefits.ca/fr/home/)", "summaryDescription" : "Head, Regulatory Affairs, General Medicine and Vaccines Canada at Sanofi. Skills: Regulatory Affairs, Team Leadership, Health Canada Submissions. Provide leadership to regulatory professionals. 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As a Senior Wellbeing Coordinator, you’ll play a key role in bringing that vision to life for our clients. In this role, you’ll partner closely with our National Wellbeing and Health Management Practice to deliver high-impact programs that support employee health and organizational outcomes. You’ll blend hands-on program execution with client-facing partnership—serving as both the engine behind seamless delivery and a trusted resource to consultants and account teams. If you thrive in a fast-paced, client-focused environment and enjoy turning strategy into action, this is an opportunity to make a meaningful impact at scale. What You’ll Do Drive Wellbeing Program Delivery Lead the end-to-end execution of onsite and virtual wellbeing initiatives (health fairs, flu clinics, screenings, campaigns, and more) Manage logistics, timelines, and deliverables across multiple client programs simultaneously Coordinate vendors, confirm scheduling, and oversee live event execution—including troubleshooting when needed Monitor participation and outcomes to ensure programs deliver measurable results Partner with Clients Serve as a day-to-day point of contact for assigned clients Build strong, consultative relationships through proactive communication and responsiveness Support consultants and account managers with program insights, recommendations, and follow-ups Ensure all deliverables are completed on time and aligned with broader client wellbeing strategies Manage Projects 22 PTO days starting out for hourly/non-exempt employees; 12 company-observed paid holidays; 4 early-close days Generous leave time options: Paid parental leave, pregnancy disability and bonding leave, and organ donor/bone marrow donor leave Generous employee referral bonus program of $1,500 per hired referral Employee recognition programs for demonstrating EPIC’s values plus additional employee recognition awards and programs (and trips!) Employee Resource Groups: Women’s Coalition, EPIC Veterans Group Professional growth & development: Mentorship Program, Tuition Reimbursement Program, Leadership Development Unique benefits such as Pet Insurance, Identity Theft & Fraud Protection Coverage, Legal Planning, Family Planning, and Menopause & Midlife Support Additional benefits include (but are not limited to): 401(k) matching, medical insurance, dental insurance, vision insurance, and wellness & employee assistance programs 50/50 Work Culture: EPIC fosters a 50/50 culture between producers and the rest of the business, supporting collaboration, teamwork, and an inclusive work environment. It takes both production and service to be EPIC! EPIC Gives Back – Some of our charitable efforts include Donation Connection, Employee Assistance Fund, and People First Foundation We’re in the top 10 of property/casualty agencies according to “Insurance Journal” To learn more about EPIC, visit our Careers Page: https://www.epicbrokers.com/about/epic-careers/. EPIC embraces diversity in all its various forms—whether it be diversity of thought, background, race, religion, gender, skills or experience. We are committed to fostering a work community where every colleague feels welcomed, valued, respected and heard. It is our belief that diversity drives innovation and that creating an environment where every employee feels included and empowered, helps us to deliver the best outcome to our clients. California Applicants - View your privacy rights at: https://www.epicbrokers.com/wp-content/uploads/2025/01/epic-ca-employee-privacy-notice.pdf. Massachusetts G.L. c. 149 section 19B (b) requires the following statement: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #LI-MS2 #LI-Remote", "summaryDescription" : "Senior Wellbeing Coordinator at EPIC Brokers. Skills: Program delivery, Client partnership. Drive wellbeing program delivery. 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Work proactively with external partners; Support cross-functional delivery teams; Work closely with Global and Regional R&D; Work with in-house and external legal counsel; Develop and maintain collaborative relationships with peers and colleagues; Work within a team", "projectManagementSkills" : [ "Manage complex regulatory projects" ], "domainKnowledge" : "Canadian Natural Health Products; Health Canada NHP Regulations; NHP GMP standards; Supplemented foods", "domainList" : [ "canadian-natural-health-products", "health-canada-nhp-regulations", "nhp-gmp-standards", "supplemented-foods" ], "domainSpecificKnowledge" : [ "Canadian Natural Health Products", "Health Canada NHP Regulations", "NHP GMP standards", "Supplemented foods" ], "communicationSkills" : "Verbal communication skills; Written communication skills; Analysis; Interpretation; Reasoning", "documentationSkills" : "Technical writing; Regulatory documentation compilation; Maintain up-to-date records; Maintain repositories of current labelling; Proper version control; Document integrity", "qualificationsBasic" : "5+ years of direct Canadian natural health product regulatory experience, Bachelors or Master’s degree in regulatory affairs, science, medical sciences, pharmacology etc. ; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job, In-depth Knowledge and experience on Health Canada quality & regulatory and applicable laws and regulations including NHP GMP standards, Experience in Health Canada NHP regulatory submissions, Foods/Supplemented foods and product licensing systems, Technical writing experience in a compliance environment such as microbiology, food science, chemistry, or biochemistry, Ability to review/ complete efficacy and/or safety assessments and dossiers as required for the product classification type for NHPs, Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external clients, verbal and written communication skills (including analysis, interpretation, & reasoning), Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment, Self-motivated with critical attention to detail, deadlines, and reporting, Excellent English written and verbal communication skills", "qualificationsPreferred" : "experience in foods/Supplemented foods", "remoteFriendly" : false, "rawDescription" : "ABOUT UNILEVER With 3.4 billion people in over 190 countries using our products every day, Unilever is a business that makes a real impact on the world. We work on brands that are loved and improve the lives of our consumers and the communities around us. We are driven by our purpose: to make sustainable living commonplace, and it is our belief that doing business the right way drives superior performance. At the heart of what we do is our people – we believe that when our people work with purpose, we will create a better business and a better world. At Unilever, your career will be a unique journey, grounded in our collaborative and flexible working environment. Our organizational ambition centres around creating workplaces that foster equity, diversity, inclusion and belonging across all aspects of our business. We don’t believe in the ‘one size fits all’ approach and instead we will equip you with the tools you need to shape your own future. WHO WE ARE We are the Wellbeing Collective Group at Unilever, focused on building and growing brands in the health and wellness space. Wellbeing is a large and dynamic global category that spans Vitamins, Minerals and Supplements, alongside adjacent areas of functional hydration and nutrition. OUR BUSINESS Unilever’s Wellbeing Collective Group brings together a portfolio of high growth health and wellness brands built to help people feel better every day. The group includes a set of category leading brands acquired in the US including OLLY, Liquid I.V., Nutrafol, SmartyPants, Welly and Onnit, as well as Equilibra (Italy). Each brand is distinct in purpose, proposition and culture, yet united by a shared focus on delivering superior consumer experiences across health and wellbeing. We are committed to continuing to grow this strategic business for Unilever by leveraging the full strength of Unilever’s capabilities, including expanding the reach of our portfolio internationally. We work in an agile, fast-moving environment, collaboratively within the team and with our Unilever colleagues around the world. We work in a project-based, networked way where everyone needs to be able to take a step back and think strategically, as well as roll up their sleeves and get their hands dirty, to be entrepreneurial and experiment, as well as bring in the best of Unilever and work the structures of a large company, and to take charge and lead, as well as follow and support others. ROLE PURPOSE Are you excited to join an expert team to ensure Canadian regulatory compliance for fast-growing market leading US supplement businesses? If so, Regulatory Affairs (RA) Assistant Manager - Canada, part of Unilever Wellbeing Collective (natural health products) could be an ideal role for you! As RA Assistant Manager Canada, you will provide regulatory expertise and assessments for the Canadian Natural Health Products business. This role is focused on compliance to Health Canada’s Natural Health Product (NHP) Regulations with end-to-end oversight of the portfolio from product development/formulation, product license applications, product launches to post license changes. You will partner closely with all Unilever stakeholders such as R&D, Quality, Legal, Marketing, Brand Management, Suppliers, Regulatory Authorities and Trade Associations. Preference will be given to candidates with experience in foods/Supplemented foods. WHAT YOU’LL DO (KEY RESPONSIBILITIES) Liaise between business partners and Health Canada to ensure all stakeholders have accurate information and understanding of regulatory requirements for natural health product registrations (product license applications, PLAs). Work proactively with external partners and support cross-functional delivery teams for complex regulatory projects – classification assessment, market entry assessment, regulatory query response, regulatory compliance projects etc. Perform product submission classifications for NHPs (Compendial/Class 1, Class 2, or Class 3 submissions) and assess ingredients for acceptability as appropriate to the product monograph or Class 3 (non-monograph) submission evidence. Maintain products through the entire product life cycle, from product development/formulation to post license changes, as applicable to the product classification, while keeping business partners informed of potential impact to product supply/availability. Work closely with Global and Regional R&D to assure all technical and Canadian specific requirements are met for natural health products. Review / Substantiate marketing and scientific claims as appropriate to the product classification and work with R&D for evidence requirements for claims. Defend product and claims with relevant Health Canada authorities. Work with in-house and external legal counsel to resolve labelling conflicts, and/or other issues when ambiguity exists in the NHP regulations by applying risk management principles to ensure consumer and brand protection. Monitor, interpret and validate current and changing regulatory landscape and communicate potential impact these activities may have on the innovation/ product maintenance. Compile and maintain regulatory documentation as required; ensures that appropriate, up-to-date records are maintained for compliance, including maintaining repositories of current labelling and ensuring proper version control and document integrity. Work with Quality & R&D to establish release specifications that are in line with submitted natural health product license, and work with importation & QA team for Site licence and Finish product testing requirements, to help establish testing as per the Quality of NHP Guidance. WHAT YOU’LL NEED TO SUCCEED 5+ years of direct Canadian natural health product regulatory experience. Bachelors or Master’s degree in regulatory affairs, science, medical sciences, pharmacology etc.; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job required. In-depth Knowledge and experience on Health Canada quality & regulatory and applicable laws and regulations including NHP GMP standards. Experience in Health Canada NHP regulatory submissions, Foods/Supplemented foods and product licensing systems. Technical writing experience in a compliance environment such as microbiology, food science, chemistry, or biochemistry. Ability to review/ complete efficacy and/or safety assessments and dossiers as required for the product classification type for NHPs. Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external clients. Strong verbal and written communication skills (including analysis, interpretation, & reasoning). Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment. Self-motivated with critical attention to detail, deadlines, and reporting. Excellent English written and verbal communication skills. Pay: The pay range for this position is $84,900-$127,300. Unilever takes into consideration a wide range of factors that are utilized in making compensation decisions including, but not limited to, skill sets, experience and training, licensure and certifications, qualifications and education, and other business and organizational needs. Bonus: This position is bonus eligible. Benefits: Unilever employees are eligible to participate in our benefits plan. Should the employee choose to participate, they can choose from a range of benefits to include, but is not limited to, health insurance (including prescription drug, dental, and vision coverage), retirement savings benefits, life insurance and disability benefits, parental leave, sick leave, paid vacation and holidays, as well as access to numerous voluntary benefits. Any coverage for health insurance and retirement benefits will be in accordance with the terms and conditions of the applicable plans and associated governing plan documents. Unilever uses artificial intelligence tools in the hiring process to screen or assess applicants. However, hiring decisions will be made by the line manager and in accordance with applicable employment standards and human rights laws. All information collected, used or disclosed during the application and interview process will be subject to Unilever’s Privacy Policy \\------------------------------------------------------------ Unilever Canada is an organization committed to diversity and inclusion to drive our business results and create a better future every day for our diverse employees, global consumers, partners, and communities. We believe a diverse workforce allows us to match our growth ambitions and drive inclusion across the business. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity or expression, age, national or ethnic origin, marital status, family status, disability, genetic characteristics, and a conviction for which a pardon has been granted. If you are an individual with a disability in need of assistance at any time during our recruitment process, please contact us at _[NA.Accommodations @unilever.com](mailto:NA.Accommodations@unilever.com)_. Please note: These lines are reserved for individuals with disabilities in need of assistance and are not a means of inquiry about positions or application statuses. Unilever Canada est une organisation engagé à la diversité et à l'inclusion pour stimuler nos résultats d'affaires et créer un meilleur avenir chaque jour pour nos employés, les consommateurs globaux, les partenaires et les communautés. Nous croyons qu'un effectif diversifiée nous permet de faire correspondre nos ambitions de croissance et de stimuler l'inclusion dans l'entreprise. Tous les candidats qualifiés recevront la considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identité ou l'expression de genre, l'âge, l'origine nationale ou ethnique, l'état matrimonial, la situation familiale, l'invalidité, les caractéristiques génétique, et une condamnation pour laquelle un pardon a été accordée. Si vous êtes une personne handicapée qui a besoin d'aide à tout moment au cours de notre processus de recrutement, veuillez communiquer avec nous au _[NA.Accommodations @unilever.com](mailto:NA.Accommodations@unilever.com)_. Veuillez noter: ces lignes sont réservées aux personnes handicapées ayant besoin d'aide et ne sont pas un moyen d'enquêter sur les postes.", "summaryDescription" : "Regulatory Affairs Assistant Manager Canada, Wellbeing Collective at Unilever. Skills: Canadian regulatory compliance, Natural Health Products, Health Canada regulations. Provide regulatory expertise and assessments for Canadian NHP business. 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"https://job-boards.greenhouse.io/beelinemedicines/jobs/4235037009", "externalId" : "4235037009", "industryFunction" : { }, "structuredLocations" : [ { "country" : "United States", "continent" : "na", "workMode" : "hybrid" } ], "locationText" : "United States", "experienceLevel" : "Director", "professionalSkills" : [ "Regulatory affairs", "Scientific messaging", "Vendor management", "Submission strategy" ], "hardSkillsList" : [ "Medical writing", "Scientific accuracy", "Regulatory compliance", "ICH guidelines", "Pharmacovigilance documentation" ], "softSkillsList" : [ "Active listening" ], "hardSkills" : [ { "name" : "Medical writing", "level" : "intermediate" }, { "name" : "Scientific accuracy", "level" : "intermediate" }, { "name" : "Regulatory compliance", "level" : "intermediate" }, { "name" : "ICH guidelines", "level" : "intermediate" }, { "name" : "Pharmacovigilance documentation", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Active listening" } ], "majorSkills" : "Medical writing, Regulatory affairs, Scientific documentation", "majorSkillsList" : [ "Medical writing", "Regulatory affairs", "Scientific documentation" ], "coreResponsibilities" : "Own medical writing execution, Author regulatory documents, Coordinate scientific documents, Review scientific documents, Contribute to submission strategy, Lead scientific messaging consistency, Represent Medical Writing, Collaborate with Clinical Development, Collaborate with Nonclinical, Collaborate with Biostatistics, Collaborate with Safety, Collaborate with Regulatory Affairs, Provide guidance to contributors, Provide oversight to writers, Manage external writers, Own document timelines, Manage integrated trackers, Align on resourcing needs, Mitigate bottlenecks, Provide status updates, Establish authoring process, Establish review process, Establish QC process, Establish approval process, Develop training materials, Evaluate AI tools, Evaluate digital tools", "teamCollaboration" : "Cross-functional forums; Cross-functional review cycles; Cross-functional teams", "projectManagementSkills" : [ "Document timelines", "Deliverable tracking" ], "domainKnowledge" : "Immunology; Inflammation; Autoimmune disease; ICH CTD format; ICH E3; ICH E6; ICH E8; ICH M4; Pharmacovigilance documentation", "domainList" : [ "immunology", "inflammation", "autoimmune-disease", "ich-ctd-format", "ich-e3", "ich-e6", "ich-e8", "ich-m4", "pharmacovigilance-documentation" ], "domainSpecificKnowledge" : [ "Immunology", "Inflammation", "Autoimmune disease", "ICH CTD format", "ICH E3", "ICH E6", "ICH E8", "ICH M4", "Pharmacovigilance documentation" ], "toolProficiency" : [ "Veeva Vault" ], "communicationSkills" : "Scientific messaging; Verbal communication; Written communication; Executive presentations; Strategic updates", "documentationSkills" : "Regulatory documents; Scientific documents; Clinical documents; Nonclinical documents; Protocols; CSRs; IBs; SAPs; ICFs; INDs/CTAs; BLA/NDA components; CTD modules; Medical writing standards; SOPs; Templates; ICH requirements; Publication planning; Journal submissions; Congress submissions", "continuousLearning" : "Evolving regulatory guidance; Industry best practices", "innovationCreativity" : "AI tools; Digital tools", "problemSolvingSkills" : "Mitigate bottlenecks; Finding creative ways", "specialRequirements" : "Periodic travel to offices", "qualificationsBasic" : "Advanced degree in life sciences, 7+ years medical writing experience, Extensive experience authoring regulatory submissions, Thorough knowledge of FDA/EMA requirements, Experience developing Medical Writing SOPs, Proficiency with document management systems", "qualificationsPreferred" : "Deep scientific expertise in immunology, Experience building Medical Writing function, Publication planning experience", "remoteFriendly" : true, "workSiteFlexibility" : "Hybrid", "rawDescription" : "About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully. Job Summary: The Associate Director, Regulatory Affairs Medical Writing is a hands-on role responsible for clear scientific messaging, the development and coordination of high-quality regulatory, nonclinical, clinical, and other scientific documents in support of the company’s I the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need. Essential Duties and Responsibilities: Own day‑to‑day execution of medical writing activities, contributing directly to authoring and quality review while coordinating internal and external resources to ensure high‑quality, on‑time delivery of regulatory and scientific documents. Author, coordinate, and review key clinical and regulatory documents, including protocols and amendments, CSRs, IBs, SAPs, ICFs, INDs/CTAs, and selected BLA/NDA components, ensuring scientific accuracy, regulatory compliance, and consistency of content. Contribute to shaping the strategy for submission narratives and key messages, leading scientific messaging consistency across CTD modules. Represent Medical Writing in relevant cross‑functional and governance forums to support alignment on submission strategy and document readiness. Collaborate closely with Clinical Development, Nonclinical, Biostatistics, Safety, and Regulatory Affairs to plan, sequence, and execute document deliverables, coordinating cross‑functional review cycles and ensuring timely, integrated input. Provide practical guidance and oversight to internal contributors and external medical writers, including vendor management, scope definition, deliverable tracking, and consistent application of Medical Writing standards, templates, and SOPs aligned with ICH and regional requirements. Own document timelines and individually or in collaboration with project management, maintain and actively manage integrated trackers across programs, partnering with line management to align on resourcing needs, anticipate and mitigate bottlenecks, and finding creative ways to provide regular, transparent status updates to cross‑functional teams and leadership. Establish a clear process for the authoring, review, QC and approval of regulatory documents to be submitted to heath authorities. Develop training materials for the cross functional team to ensure adoption of the agreed process. Collaborate with IT, Quality, and Regulatory stakeholders to evaluate AI and digital tools that enhance medical writing efficiency and consistency, while ensuring compliance with data privacy, system validation, and regulatory expectations; remain current on evolving regulatory guidance and industry best practices. Perform other duties and responsibilities as assigned. Qualifications: Education: Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or a related discipline required. Minimum of 7+ years of medical writing experience in the pharmaceutical or biotech industry, Extensive experience authoring and overseeing regulatory submissions in ICH CTD format, including CSRs, ISS/ISE, IBs, and IND/CTA packages. Deep scientific expertise in immunology, inflammation, or autoimmune disease is strongly preferred, with the ability to rapidly acquire technical knowledge in new therapeutic areas. Demonstrated ability to manage multiple concurrent document deliverables and writing teams in a high-priority regulatory environment. Thorough knowledge of FDA and EMA regulatory writing requirements, ICH E3, E6, E8, and M4 guidelines, and applicable pharmacovigilance documentation standards. Experience developing and enforcing Medical Writing SOPs, style guides, and document templates in a regulated pharmaceutical environment. Proficiency with document management systems, electronic submission tools, and publishing platforms such as Veeva Vault or equivalent. Strong publication planning experience, including familiarity with ICMJE authorship guidelines, journal submission processes, and scientific congress submission requirements. Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech organization is highly desirable. Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners. Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams and board-level stakeholders. Strong active listening skills and the ability to synthesize input from diverse perspectives into clear, actionable communications that build alignment and drive decision-making. Salary Range: The expected annual salary range for this position is listed below. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance. Salary Range $193,000—$215,000 USD Benefits: We offer a comprehensive benefits package including: Medical, Dental & Vision insurance (employee premiums 100% covered by company) 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge Flexible work arrangements / hybrid schedule Health Savings Account (HSA) *Benefits are subject to eligibility requirements and plan terms. Additional details provided during the offer process* Equal Employment Opportunity: Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. Reasonable Accommodation: If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates. Privacy Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines", "summaryDescription" : "Associate Director, Regulatory Affairs Medical Writing at Beeline Medicines. Skills: Medical writing, Regulatory affairs, Scientific documentation. Own medical writing execution. Author regulatory documents", "postedDate" : "2026-06-12T22:09:09.187", "createdAt" : "2026-06-12T22:09:09.187", "lastUpdated" : "2026-06-15T00:40:22.706", "ingestTimestamp" : "2026-06-12T22:09:09.187", "mongoId" : "6a2c5e6674d8ee00a08e3c22", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 175000, "salaryAnnualMax" : 250000, "salaryBand" : "150k-200k", "hasSalary" : true, "allSkills" : [ "Medical writing", "Scientific accuracy", "Regulatory compliance", "ICH guidelines", "Pharmacovigilance documentation", "Active listening", "Regulatory affairs", "Scientific documentation", "Scientific messaging", "Vendor management", "Submission strategy", "Document timelines", "Deliverable tracking", "Immunology", "Inflammation", "Autoimmune disease", "ICH CTD format", "ICH E3", "ICH E6", "ICH E8", "ICH M4", "Veeva Vault" ], "skillCount" : 22, "jobCategory" : "other", "jobSubcategory" : "regulatory-&-quality", "dataQualityScore" : 0.8888889, "daysOld" : 2, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Biotechnology" }, { "id" : "6a305250f292fd229cf0cc27", "title" : "Territory Manager Western Canada - RSSW", "company" : "Distribution Stox", "industry" : "Logistics And Supply Chain", "salary" : { "min" : 95000.0, "max" : 135000.0, "currency" : "CAD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Senior Territory Manager in Edmonton, Canada, adjusted for the logistics industry and mid-level experience." }, "location" : "Edmonton, AB, Canada", "locations" : [ "Edmonton", "AB", "Canada" ], "timestamp" : "2026-06-16T07:06:24.731", "fingerprint" : "fbd050a241af9080f64843f68a3cbc23b8be1e8f69198c12824b5946bad104f7", "source" : "smartrecruiters", "language" : "en", "applyUrl" : "https://jobs.smartrecruiters.com/DistributionStox2/744000132221970-territory-manager-western-canada-rssw", "externalId" : "744000132221970", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Edmonton", "state" : "Alberta", "country" : "Canada", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "53.5462055,-113.4912410" } ], "locationText" : "Edmonton, Alberta, Canada", "employmentType" : "FULL_TIME", "experienceMinYears" : 0, "experienceMaxYears" : 2, "experienceLevel" : "entry", "technicalSkills" : "MS Office, CRM", "professionalSkills" : [ "Business development", "Competitive analysis", "Sales performance analysis", "Pipeline management", "Technical support" ], "majorSkills" : "Sales representation, Business development, Client relationships", "majorSkillsList" : [ "Sales representation", "Business development", "Client relationships" ], "coreResponsibilities" : "Develop business development strategies, Implement business development strategies, Adjust business development strategies, Identify new markets, Target new markets, Develop new markets, Identify customer segments, Target customer segments, Develop customer segments, Represent the company, Increase brand presence, Conduct competitive analysis, Identify market opportunities, Identify market threats, Maintain client relationships, Strengthen client relationships, Develop strategic partnerships, Expand distribution network, Ensure follow-up with key accounts, Maximize client growth potential, Analyze sales performance, Adjust sales strategies, Use CRM tools, Document activities, Ensure pipeline management, Advise clients on products, Provide technical support, Train clients on products, Train clients on new releases, Train clients on best practices, Collaborate with internal teams", "teamCollaboration" : "Internal teams", "domainKnowledge" : "Tire and wheel industry; Vehicle wheel industry", "domainList" : [ "tire-and-wheel-industry", "vehicle-wheel-industry" ], "domainSpecificKnowledge" : [ "Tire and wheel industry", "Vehicle wheel industry" ], "toolProficiency" : [ "CRM tools" ], "communicationSkills" : "Communication skills", "continuousLearning" : "Training and development program", "specialRequirements" : "Company-provided vehicle, Mileage reimbursement", "qualificationsBasic" : "5 years of experience in sales representation, Field sales experience, Develop and maintain business relationships, Business acumen, Results-oriented approach, Manage multiple files simultaneously", "qualificationsPreferred" : "Demonstrated leadership, Communication skills, Team player mindset, Listening skills, Customer service orientation, Attention to detail, Comfortable with technology", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "Position under RSSW Edmonton, ON At Unimax, Distribution Stox, and RSSW, sales, logistics, and distribution are at the core of our operations as a Canadian distributor of tires and wheels. Our vision is to become the most efficient and high-performing tire and wheel distributor in the country. By joining the Unimax, Distribution Stox, and RSSW family, you will be part of a positive, healthy, and respectful work environment. Our workplace is welcoming, inclusive, and collaborative, with teamwork at the heart of our values. We take pride in recognizing your efforts and achievements. About RSSW We specialize in the import, sale, and distribution of steel and alloy wheels for passenger cars and light trucks. We are positioned as a key player in the Canadian vehicle wheel industry. With four distribution centers across the country, we are a leader in the Canadian market. Through a diversified offering, optimized logistics, and a dynamic growth strategy, we continue to strengthen our presence nationwide. 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US regulatory requirements; EU MDR requirements; International geographies regulations; QSR standards; ISO standards; EN standards", "domainList" : [ "medical-device-software-regulations", "us-regulatory-requirements", "eu-mdr-requirements", "international-geographies-regulations", "qsr-standards", "iso-standards", "en-standards" ], "domainSpecificKnowledge" : [ "Medical device software regulations", "US regulatory requirements", "EU MDR requirements", "International geographies regulations", "QSR standards", "ISO standards", "EN standards" ], "communicationSkills" : "Verbal communication; Written communication", "continuousLearning" : "Tuition reimbursement; Student debt program; Education benefit", "problemSolvingSkills" : "Problem-solving skills; Investigate and solve problems", "specialRequirements" : "10 % of the Time travel, Continuous sitting for prolonged periods, Awkward/forceful/repetitive (arms above shoulder, bent wrists)", "qualificationsBasic" : "Bachelor's Degree in related field, Minimum 9 years related work experience", "qualificationsPreferred" : "Master's degree, Submission / registration types and requirements, Experience with Class III implantable devices, Experience managing and leading a team, Certification is a plus, Must be able to lead and manage multiple and competing priorities, Working knowledge of QSR, ISO, and EN standards, Working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies, Experience with medical device software requirements and software regulations, Ability to identify risk areas and escalate issues", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. ## **JOB DESCRIPTION:** **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: * Career development with an international company where you can grow the career you dream of * Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. * An excellent retirement savings plan with high employer contribution * Tuition reimbursement, the [Freedom 2 Save](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree * A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune * A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists **The Opportunity** Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. We are recruiting for a **Senior** **Regulatory Affairs Manager** to join our team on-site in Alameda, CA. In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation. Additionally, will be responsible for compiling regulatory submissions and ensure data is effectively presented for the registration of products worldwide. **What You’ll Work On** * Recruits, coaches and develops organizational talent. * Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. * Creates an entrepreneurial environment. * Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. * May manage and coach a team of regulatory employees. * Keeps the organization's vision and values at the forefront of decision making and action. * Demonstrates effective change leadership. * Builds strategic partnerships to further departmental and organizational objectives. * Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. * Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.). * Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives. * Develops, monitors and appropriately adjusts the annual budget for department(s). * Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives. * Assess proposed regulations and communicate new requirements to the organization. * Lead the RA process for Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input. * Assist with promotional content development and review for compliance before distribution. * Lead Regulatory Affairs Ad & Promo SOP development and review. **Required****Qualifications** * Bachelor’s Degree in a related field or an equivalent combination of education and experience * Minimum 9 years related work experience. * Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals. * Monitors costs of projects and of human and material resources within a department or unit. * Monitors company-wide indicators such as market share and profitability. * Monitors external environment in area of technical or professional responsibility. * Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups. * Facilitates others' participation in the continuous improvement program. * Investigates and solves problems that impact work processes and personnel within or across units or departments. * Develops and communicates a vision for the organizational unit assigned. **Preferred** **Qualifications** * Master’s degree * Submission / registration types and requirements * Experience working with Class III implantable devices. * Effective verbal and written communication with diverse audience and team. * Analytical thinking with good problem-solving skills. * Experience managing and leading a team. * Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). * Must be able to lead and manage multiple and competing priorities and manage programs. * Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies. * Experience with medical device software requirements and software regulations. * Ability to identify risk areas and escalate issues as appropriate. [**Apply Now**](https://www.jobs.abbott/us/en) **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:**[www.abbottbenefits.com](http://www.abbottbenefits.com/pages/candidate.aspx) Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at [www.abbott.com](http://www.abbott.com/), on Facebook at [www.facebook.com/Abbott](http://www.facebook.com/Abbott) and on Twitter @AbbottNews.Connect with us at [www.abbott.com](http://www.abbott.com/), on Facebook at [www.facebook.com/Abbott](http://www.facebook.com/Abbott) and on Twitter @AbbottNews and @AbbottGlobal. **The base pay for this position is** $130,700.00 – $261,300.00 In specific locations, the pay range may vary from the range posted. ## **JOB FAMILY:** Regulatory Operations ## **DIVISION:** LNGO Lingo ## **LOCATION:** United States > Alameda : 2601 Harbor Bay Parkway ## **ADDITIONAL LOCATIONS:** ## **WORK SHIFT:** Standard ## **TRAVEL:** Yes, 10 % of the Time ## **MEDICAL SURVEILLANCE:** No ## **SIGNIFICANT WORK ACTIVITIES:** Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. 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materials, Address agency questions, Provide support to marketed products, Review labeling changes, Review product changes, Review process changes, Prepare FDA submissions, Provide international submission support, Maintain worldwide regulatory requirements proficiency, Establish RA department relationships, Establish cross-functional team relationships, Develop positive reviewer relationships, Assist in FDA negotiations, Assist in agency negotiations", "teamCollaboration" : "Cross-functional teams; RA department; Device reviewers", "domainKnowledge" : "Class II devices; Class III devices; Peripheral and Carotid Disease; End Stage Renal Disease; Peripheral Embolization; Deep Venous Disease; Medical Device Regulation; Medical Device Directive", "domainList" : [ "class-ii-devices", "class-iii-devices", "peripheral-and-carotid-disease", "end-stage-renal-disease", "peripheral-embolization", "deep-venous-disease", "medical-device-regulation", "medical-device-directive" ], "domainSpecificKnowledge" : [ "Class II devices", "Class III devices", "Peripheral and Carotid Disease", "End Stage Renal Disease", "Peripheral Embolization", "Deep Venous Disease", "Medical Device Regulation", "Medical Device Directive" ], "communicationSkills" : "Written communication; Verbal communication", "documentationSkills" : "Regulatory filings; Supportive documentation", "qualificationsBasic" : "NFQ Level 8 Bachelor’s degree, 2 years relevant experience, Master’s degree no experience", "qualificationsPreferred" : "Experience with Class II/III devices, Experience with FDA requirements, Experience with MDD, Experience with MDR, Experience with medicinal consultations, Experience with global regulatory requirements, Experience with quality standards", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. # **A Day in the Life** **Medtronic** At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. **Our Purpose** Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. This position will reside in the Peripheral Vascular Health organization that cares for millions of patients globally with life-enhancing therapies. The Regulatory Affairs Specialist is responsible for worldwide regulatory activities for new and existing Class II and Class III devices and provide advice on regulatory requirements. The Regulatory Affairs Specialist is responsible for assessing device changes for regulatory implications and for performing relevant regulatory actions in support of the implementation of these changes. This role focuses on a wide variety of regulatory tasks to allow the Regulatory Affairs Specialist to make the most of his/her existing knowledge base while growing his RA skill set daily working within a collaborative team environment. **_Come for a job, stay for a career!_** **A Day in The Life Of:** Responsibilities may include the following and other duties may be assigned. * Lead or compile all materials required in submissions, license renewal and annual registrations. Work with engineers and technical experts to address questions from regulatory agencies. * Provide support to currently marketed products as necessary. This includes reviewing labeling, product or process changes as well as supportive documentation for changes requiring RA agency review. Prepare submissions and reports for FDA or provide support and documentation for international submissions. * Maintain proficiency in worldwide regulatory requirements. * Establish and maintain good relationships within the RA department, cross functional teams and assist in developing and maintaining positive relationships with device reviewers through verbal and written communications. * May assist in negotiations with the FDA or other regulatory agencies for defined projects. * Other tasks, as assigned. **Key Skills & Experience** * Minimum NFQ Level 8 Bachelor’s degree in Regulatory Science, Pharmaceutical, Biomedical or related medical/scientific field with minimum 2 years of relevant experience in medical device industry. * Or Master’s degree in Regulatory Science, Pharmaceutical, Biomedical or related medical/scientific field with no prior experience. Nice to have: * Experience working with Class II/III medical devices. * Experience with FDA requirements, guidance documents, Medical Device Directive (MDD), Medical Device Regulation (MDR), medicinal consultations and/or other global regulatory requirements and quality standards. * Effective negotiation and written/oral communication skills. * Effective interpersonal, organizational and time management skills. * Effective team member. * Detail-oriented **Medtronic offer a competitive salary and flexible Benefits Package** #INDJ #LI-Onsite **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. # **Benefits & Compensation** **Medtronic offers a competitive Salary and flexible Benefits Package** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 48,400.00 EUR - 72,600.00 EUR | This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). # **About Medtronic** # We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity [here](http://www.medtronic.com)", "summaryDescription" : "Regulatory Affairs Specialist at Medtronic. Skills: Regulatory affairs, Medical devices, Global regulatory requirements. Lead submissions compilation. Compile license renewal materials", "postedDate" : "2026-06-10T17:21:35.510", "createdAt" : "2026-06-11T17:21:35.458", "lastUpdated" : "2026-06-12T22:40:02.487", "ingestTimestamp" : "2026-06-11T17:21:35.458", "mongoId" : "6a2a73d374d8ee00a06515cc", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "sourceUrl" : "https://medtronic.wd1.myworkdayjobs.com/MedtronicCareers/job/Galway-County-Galway-Ireland/Regulatory-Affairs-Specialist_R68241-1", "salaryBand" : "30k-50k", "hasSalary" : false, "allSkills" : [ "Regulatory requirements", "Device changes assessment", "Regulatory actions", "Submissions compilation", "License renewal", "Annual registrations", "Product changes review", "Process changes review", "Supportive documentation preparation", "FDA submissions", "International submissions", "Worldwide regulatory requirements", "Device reviewer communication", "Negotiation", "Interpersonal skills", "Organizational skills", "Time management skills", "Regulatory affairs", "Medical devices", "Global regulatory requirements", "Risk management", "Legal analysis", "Compliance oversight", "Class II devices", "Class III devices", "Peripheral and Carotid Disease", "End Stage Renal Disease", "Peripheral Embolization", "Deep Venous Disease", "Medical Device Regulation", "Medical Device Directive" ], "skillCount" : 31, "jobCategory" : "other", "seniorityLevel" : "mid", "dataQualityScore" : 0.8888889, "daysOld" : 2, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Healthcare" } ], "status" : 200, "message" : "regulatory affairs assistant manager canada wellbeing collective jobs", "metadata" : { "title" : "regulatory affairs assistant manager canada wellbeing collective" }, "pagination" : { "page" : 0, "limit" : 50, "totalCount" : 131482, "totalPages" : 2630, "hasNext" : true, "hasPrevious" : false } }

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