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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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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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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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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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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; Identify regulatory challenges; Identify operational challenges; Suggest practical solutions", "specialRequirements" : "Reside within EST or CST", "qualificationsBasic" : "5 years relevant experience, Expanded Access experience, Working knowledge Pharmacovigilance, Bachelor's or Master's degree, Life Sciences degree, Experience with clients, Experience with external stakeholders", "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 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

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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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This role will play a critical part in preparing the organisation for upcoming European regulatory requirements related to building energy performance. ## Requirements #### Key Responsibilities * Lead the end-to-end delivery of changes required to ensure readiness for the EU Energy Performance of Buildings Directive (EPBD). * Develop and manage a comprehensive delivery plan, ensuring alignment across multiple workstreams. * Coordinate cross-functional teams to deliver key milestones on time and within scope. * Oversee business, process, data, and system changes required to support EPBD compliance. * Track and manage risks, issues, and dependencies, implementing mitigation strategies where necessary. * Support the development and delivery of interim solutions where full implementation may be phased. * Prepare regular status reports and updates for senior stakeholders. * Engage with governance forums, including Steering Committees and regulatory stakeholders. #### Programme Context * The EPBD is a European regulation aimed at reducing carbon emissions from buildings by 2050. * It is expected to be transposed into Irish law by May 2026. * The regulation will drive significant change, including: * Updates to BER (Building Energy Rating) scales and certificates * Enhanced data requirements * Changes to customer documentation * Updates to internal processes and supporting systems How We Work: Delta Capita is an equal opportunity employer. We positively encourage applications from suitably qualified and eligible candidates regardless of age, colour, disability, national origin, ancestry, race, religion, gender, sexual orientation, gender identity and/or expression, veteran status, genetic information, or any other status protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. If you require any reasonable adjustments through your interview process, please use the designated space within the application questionnaire. This is a fixed-term contract full-time position located in Dublin. As the selection and interview process is ongoing, please submit your application in English as soon as possible, if your profile is selected, a member of our team will contact you within 4 weeks. For this role a valid working permit for Ireland is mandatory. Expectations regarding hybrid working: As we are a Service Provider and Consulting firm servicing clients, our policy for physically working from the office (which may be the clients' offices or our own offices depending on the client) aligns to what our clients' policies and expectations are and these vary. Most of our clients now require a minimum of 3 days per week in the office, 2 days from home, and accordingly this is also the minimum expectation that Delta Capita require. However, some of our clients have now moved up to 4 days and even 5 days in the office and we require candidates to be flexible to meet our client demands. Who We Are: Delta Capita Group is a global managed services, consulting, and solutions provider with a unique combination of experience in Financial Services and technology innovation capability. Our mission is to reinvent the financial services value chain providing technology based mutualised services for financial institutions for non-differentiating services. 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Location: Tokyo preferred (Osaka or remote within Japan is negotiable) Level: Open from Junior to Mid level candidates * Prepare clinical trial regulatory submission dossiers, including applications for import and export licenses * Track regulatory project documentation flow and progress reporting * Review translations of essential documents subject to clinical trial submission * Liaise with project teams to procure documents necessary for regulatory submissions * Communicate with regulatory authorities, sponsors, and vendors on all regulatory-related matters * Track changes/amendments to legislative acts pertaining to clinical trials in Japan * Review documents to greenlight IP release to sites * Manage safety reporting to authorities * Deliver training on the regulatory environment in Japan * Participate in the regulatory aspects of feasibility research ## Qualifications * University degree in Life Sciences, Medicine or Pharmacy or an equivalent combination of education, training, and experience * Experience with clinical trial submissions to PMDA * Knowledge of the regulatory environment for clinical research * Full working proficiency in English and Japanese * Detail-oriented * Communication (Japanese and English), collaboration, and problem-solving skills ## Additional Information How are we different? 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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. 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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. 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Interpret regulations", "qualificationsBasic" : "EMEA Regulatory Consultant experience, UK based, EU and UK regulatory frameworks experience, Financial services regulatory experience, Fintech regulatory experience, Payments regulatory experience, Crypto regulatory experience, Regulated businesses regulatory experience, AML/CTF/KYC/KYB experience, Financial crimes regulations experience, PSD2 working knowledge, Payments regulation working knowledge, Compliance operations experience, EU and UK regulatory developments analysis experience", "qualificationsPreferred" : "Digital Services Act exposure, DORA exposure, Identity regulations exposure, EIDAS regulations exposure, Trust services exposure, Platform regulation exposure", "remoteFriendly" : true, "workSiteFlexibility" : "Hybrid", "rawDescription" : "Are you ready to embark on a career that truly affects people around the world? Trulioo invites you to be a catalyst for change in the dynamic realm of digital identity verification. As the global front-runner in our industry, we are redefining how businesses grow, innovate and comply online. Picture yourself at the forefront of innovation, contributing to our award-winning platform that enables organizations worldwide to quickly onboard customers, optimize costs and combat fraud. Fueled by Silicon Valley support, Trulioo stands as the trusted platform that can verify more than 5 billion people and 700 million business entities spanning 195 countries. But Trulioo is more than a tech company. We are a united force of dedicated experts committed to establishing trust online - and we’re proud to be recognized as a BC Top Employer for the second consecutive year, reflecting our commitment to an inclusive, collaborative, and people-first workplace. Headquartered in Vancouver and with strategic hubs in San Diego and Dublin, we foster a culture of collaboration and open communication. Our offices support a hybrid model and staff typically work three days per week at a hub location. Join us where excitement meets innovation and contribute to a world where trust and technology unite. What We Offer - Comprehensive Benefits: We provide a robust benefits package for full-time, permanent employees, including health, dental, and vision coverage, retirement plans with company match, paid time off, parental leave, and an annual education & training stipend (equivalent to $1,000 in local currency). Specific benefits may vary by location and will be discussed further during the interview process. - Flexible Hybrid Working Environment: Our offices are designed to support both collaboration and flexibility. Enjoy weekly lunches, quality coffee, and regular social events. Many locations also feature parent rooms, on-site gyms, comfortable lounges, and adaptable workstations to support your comfort and productivity. - Wellness: We care about your well-being. Team members have access to wellness workshops and events, as well as a complimentary Headspace subscription to help you stay focused, grounded, and energized. - Employee Resource Groups: Belonging is an important part of doing your best work. Our ERGs provide an inclusive space, support and community for employees of diverse backgrounds and allies. We host informative, fun sessions and celebrations that are often open to the entire organization. Position Summary Trulioo is seeking an experienced EMEA Regulatory Consultant based in the UK to serve as a subject matter expert on EU and UK regulatory frameworks impacting financial services, fintech, payments, marketplaces, crypto, and other regulated businesses. This role will provide deep expertise in Anti-Money Laundering (AML), Counter-Terrorist Financing (CTF), KYC, KYB, and related financial crimes regulations, as well as a strong working knowledge of PSD2 and payments regulation. The EMEA Regulatory Consultant will bridge regulatory expectations, compliance operations, and product development to ensure Trulioo designs and delivers compliant, market-leading solutions for customers operating across the EU and UK. This individual will possess strong compliance operations experience, a comprehensive understanding of the evolving regulatory landscape, and the ability to critically analyze and interpret new and existing regulations impacting Trulioo’s customers. The ideal candidate will also have exposure to the Digital Services Act (DSA), Digital Operational Resilience Act (DORA), Identity and eIDAS regulations as they relate to digital identity, trust services, and platform regulation. Experience with consuming, analyzing, and distilling EU and UK regulatory developments is essential. This will be a full-time, permanent position that can be done remotely for the right candidate. What You'll Be Doing: Financial Crimes & Payments Regulatory Expertise - Provide subject matter expertise on EU and UK AML/CTF, KYC, KYB, sanctions, and PEP screening regulations. - Maintain strong knowledge of PSD2 and broader EU/UK payments regulatory frameworks. - Monitor evolving legislative and supervisory developments across EMEA jurisdictions. - Analyze and interpret regulatory changes and translate them into actionable internal and product guidance. - Support regulatory engagement, customer due diligence requests, and audit processes as needed. Product Strategy & Development Partnership - Act as a key regulatory SME to Product and Engineering teams during design, build, and UAT phases. - Ensure Trulioo’s products align with EU/UK regulatory expectations and address our customers' operational needs efficiently and effectively. - Provide insight into financial crime typologies, payment compliance practices, and emerging supervisory trends. - Support commercialization by validating regulatory positioning of new and existing solutions. Compliance Operations & Industry Practice - Bring hands-on compliance operations experience, including onboarding, transaction monitoring, investigations, SAR/STR reporting, and regulatory examinations. - Advise on operational best practices used by regulated entities in marketplaces, fintech, payments, financial services, and crypto sectors. - Identify operational challenges and translate them into product enhancements and advisory insights. Regulatory Research, Analysis & Thought Leadership - Conduct structured regulatory research across the EU and UK frameworks affecting Trulioo’s customers. - Distill complex regulatory developments into clear internal briefings and executive-level summaries. - Influence Trulioo’s strategy based on key regulatory developments trends and identify opportunities to create/enhance products to address our customers' emerging regulatory challenges - Partner with Marketing and Executive teams to create thought leadership content. - Represent Trulioo at EMEA conferences, panels, and industry forums. Compliance Management System (CMS) & Culture - Support the continued development and maturity of Trulioo’s Compliance Management System within EMEA. - Help design scalable governance processes aligned with licensing and regulatory obligations. - Embed a culture of compliance that balances regulatory rigor with innovation. - Ensure internal frameworks evolve alongside Trulioo’s growth in the region. What You’ll Bring: - 8–15+ years of experience in AML, financial crimes compliance, payments regulation, or regulatory advisory roles within EU/UK markets. - Strong expertise in EU AML Directives, UK AML regime, sanctions frameworks, and PSD2. - Hands-on compliance operations experience within regulated financial institutions, fintech, or crypto environments. - Demonstrated ability to research, evaluate, and critically analyze regulatory developments across multiple jurisdictions. - Experience in distilling complex regulations into practical operational and product guidance. - Strong communication skills and ability to influence cross-functional teams and senior leadership. - Experience supporting regulatory examinations or supervisory engagements is highly desirable. Nice to Have: - Exposure to DSA, DORA, eIDAS, digital identity, or trust services regulation. - Advanced certifications such as CAMS or equivalent financial crimes credentials. - Experience working with RegTech or compliance technology providers. - Demonstrated experience speaking at industry events or publishing regulatory insights. Thriving at Trulioo At Trulioo, you’re not just an employee. You’re a valued member of our Trulicrew on a journey of professional and personal growth with a world-class organization. With Trulioo, you have the power to revolutionize the intersection of technology, digital trust and online identity to open the global economy to everyone. Together, we can shape the digital future. We’re on the lookout for exceptional people to empower with trust, autonomy and the freedom to cultivate their potential. Your curiosity, meticulous attention to detail and passion to contribute are highly valued. If that resonates with you, apply today to become a part of our team. Join us in shaping a future where your career isn’t just a journey but also a boundless exploration into the possibilities of technology and digital identity verification. Get an inside look at life at Trulioo by following us on LinkedIn https://ca.linkedin.com/company/trulioo, or learn more about us at www.trulioo.com http://www.trulioo.com If you don’t see yourself fully reflected in every job requirement listed on the posting above, we still encourage you to reach out and apply. Research has shown that minorities and underrepresented groups often only apply when they feel 100% qualified. We are committed to creating a more equitable, inclusive and diverse company and we strongly encourage applicants of all genders, ages, ethnicities, cultures, abilities, sexual orientations, and life experiences to apply. Trulioo welcomes applications from people with disabilities. Support is available upon request for candidates taking part in all aspects of the selection process. Finally, we know from time-to-time emergencies happen and you may need to reschedule an interview - we understand and encourage you to be in communication without worrying about losing the opportunity or your credibility. Privacy Notice As part of our job application process, Trulioo collects, processes, and discloses personal data for the purpose of identifying suitable candidates for our job openings. For more detail, please visit Trulioo’s Website Privacy Policy https://www.trulioo.com/website-privacy-policy in the section “When you apply for a job”.", "summaryDescription" : "EMEA Regulatory Consultant at Trulioo. Skills: Regulatory expertise, AML/CTF, Payments regulation. Provide subject matter expertise. 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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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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, "_score" : 1035.2793, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Healthcare", "llmIndustryConfidence" : 0.98 }, { "id" : "6a2ca52a74d8ee00a09b5003", "title" : "Senior SNF Regulatory Consultant", "company" : "Polaris Group", "industry" : "Healthcare", "salary" : { "min" : 100000.0, "max" : 110000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : false }, "location" : "Remote - United States", "locations" : [ "Remote - United States" ], "certifications" : [ "Registered Nurse", "AAPACN Certification" ], "timestamp" : "2026-06-15T09:26:56.857", "fingerprint" : "822267023cce28cc619a72ab4ae9ed1454cf4d073d6eee9cdf12be392dca35af", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.greenhouse.io/polaris/jobs/5219355008", "externalId" : "5219355008", "industryFunction" : { }, "structuredLocations" : [ { "country" : "United States", "continent" : "na", "workMode" : "remote" } ], "locationText" : "United States", "employmentType" : "FULL_TIME", "experienceMinYears" : 5, "experienceMaxYears" : 10, "experienceLevel" : "Senior", "technicalSkills" : "Microsoft Office Suite, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Teams", "professionalSkills" : [ "Thought Leadership", "Industry Expertise", "Strategic Communication", "Project Management", "Content Development", "Client Service Excellence", "Active Listening", "Collaboration" ], "hardSkillsList" : [ "Regulatory guidance", "Medical record reviews", "Regulatory assessments", "Data analysis", "Quality assurance" ], "softSkillsList" : [ "Critical thinking", "Adaptability" ], "hardSkills" : [ { "name" : "Regulatory guidance", "level" : "intermediate" }, { "name" : "Medical record reviews", "level" : "intermediate" }, { "name" : "Regulatory assessments", "level" : "intermediate" }, { "name" : "Data analysis", "level" : "intermediate" }, { "name" : "Quality assurance", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Critical thinking" }, { "name" : "Adaptability" } ], "majorSkills" : "Skilled nursing, Assisted living, Regulatory changes, Operational impacts", "majorSkillsList" : [ "Skilled nursing", "Assisted living", "Regulatory changes", "Operational impacts" ], "coreResponsibilities" : "Serve as advisor, Monitor industry regulations, Interpret reimbursement updates, Communicate emerging trends, Analyze operational impacts, Develop educational content, Deliver webinars, Create thought leadership content, Respond to client questions, Conduct regulatory research, Provide timely guidance, Perform medical record reviews, Perform regulatory assessments, Perform consulting visits, Analyze client data, Prepare comprehensive reports, Review consultant reports, Maintain documentation, Maintain reports, Maintain calendars, Build client relationships, Collaborate with internal teams, Represent Polaris Group, Identify consulting opportunities, Collaborate with sales team, Participate in special projects, Lead special projects, Perform additional duties, Support business initiatives", "teamCollaboration" : "Internal teams; Sales team", "projectManagementSkills" : [ "Project management", "Program management" ], "domainKnowledge" : "Skilled nursing; Assisted living; Post-acute care; Healthcare industry; Regulatory requirements; Reimbursement updates", "domainList" : [ "skilled-nursing", "assisted-living", "post-acute-care", "healthcare-industry", "regulatory-requirements", "reimbursement-updates" ], "domainSpecificKnowledge" : [ "Skilled nursing", "Assisted living", "Post-acute care", "Healthcare industry", "Regulatory requirements", "Reimbursement updates" ], "toolProficiency" : [ "Webinar platforms", "Social media" ], "communicationSkills" : "Written communication; Verbal communication; Presentation skills; Client communications; Industry articles; Educational presentations; Webinars; Video content; Social media engagement; Conference participation; Speaking engagements; Professional industry events", "documentationSkills" : "Documentation; Reports; Solution Center records", "innovationCreativity" : "Innovation", "problemSolvingSkills" : "Critical thinking; Problem solving", "specialRequirements" : "Offsite reviews, Onsite reviews", "outcomesObjectives" : "Support client growth; Support client retention", "qualificationsBasic" : "Bachelor of Science in Nursing Degree, Director of Nursing experience, MDSC experience, Multi-site management experience, Registered Nurse license", "qualificationsPreferred" : "AAPACN Certification", "remoteFriendly" : true, "workSiteFlexibility" : "Remote", "rawDescription" : "Become an Assembler! If you are looking for a company that is focused on being the best in the industry, love being challenged, and make a direct impact on our business, then look no further! We are adding to our motivated team that pride themselves on being client-focused, biased to action, improving together, and insistent on excellence and integrity. Senior Regulatory Consultant Polaris Group, part of the Assembly Health family of companies, is seeking a dynamic, healthcare-focused Senior Regulatory Consultant. We are looking for a proactive thought leader who stays ahead of industry trends and regulatory changes, understands their impact across skilled nursing and assisted living organizations, and communicates insights effectively to clients and industry audiences. The ideal candidate is an independent, strategic communicator with strong writing and presentation skills who can create timely social media content, contribute industry articles, develop educational presentations, and deliver webinars and video content. If you are a motivated professional with strong critical thinking skills, a collaborative mindset, and a “can do/go-getter” attitude who wants to make a direct impact in post-acute care, we invite you to join our team. Become an Assembler—join us today. What our Senior Regulatory Consultants do Serve as trusted regulatory and operational advisor to skilled nursing and assisted living providers nationwide. Monitor, interpret, and communicate industry regulations, reimbursement updates, and emerging trends impacting post-acute care organizations. Independently stay ahead of healthcare industry changes and analyze operational and regulatory impacts across all levels of SNF and AL organizations. Develop and deliver timely educational content including webinars, presentations, training materials, videos, and industry resources. Create thought leadership content through social media engagement, industry articles, client communications, and conference participation. Respond to client regulatory and operational questions through the Polaris Group Solution Center hotline and email while ensuring exceptional customer service. Conduct regulatory research and provide timely guidance to consultants and clients regarding evolving industry requirements and best practices. Perform offsite and onsite medical record reviews, regulatory assessments, and episodic consulting visits as directed. Analyze client data and prepare comprehensive reports with actionable recommendations and follow-up strategies. Review consultant site visit reports for regulatory accuracy and quality assurance. Maintain accurate documentation, reports, calendars, and Solution Center records in accordance with company standards. Build strong client relationships through responsive communication, strategic guidance, and professional support. Collaborate with internal teams on product development, educational initiatives, and consulting strategies. Represent Polaris Group through conferences, speaking engagements, webinars, and professional industry events. Identify opportunities for additional consulting services and collaborate with the sales team to support client growth and retention. Participate in and lead special projects that support business initiatives, innovation, and organizational growth. Perform additional duties and strategic initiatives as assigned to support the evolving needs of the business. Why Assembly Health? We pay you for your initiative! Base compensation plus an incentivize pay program based on your performance Be part of something special—we are in high growth mode through organic growth and acquisitions Standard medical benefits, ancillary benefits including dental, vision, and short-term disability, 401(k) plan, and Paid Time off to enjoy your time away from the office Did we mention how much we love our team culture? Hosting trivia, happy hours, and other group events (some are virtual and socially distanced right now) Qualifications: Education: Bachelor of Science in Nursing Degree preferred Experience: Experience as a Director of Nursing and MDSC, multi-site management or comparable experience is Licenses/Certification: Registered Nurse, AAPACN Certification Knowledge/Skills/Ability: Thought Leadership & Industry Expertise – Demonstrates deep knowledge of the skilled nursing and assisted living industries while proactively monitoring regulatory, operational, and reimbursement changes. Serves as a trusted industry resource and strategic advisor to clients and colleagues. Strategic Communication – Exceptional written, verbal, and presentation skills with the ability to communicate regulatory and operational concepts clearly to diverse audiences. Skilled in developing presentations, webinars, educational materials, articles, video content, and social media messaging. Executive Presence & Relationship Management – Builds credibility and strong relationships with clients, leadership teams and industry partners. Effectively collaborates across all organizational levels while representing Polaris Group professionally in public and client-facing settings. Analytical & Critical Thinking – Ability to analyze complex information, identify trends, evaluate risk, and develop practical solutions and recommendations that support operational and regulatory success. Adaptability & Initiative – Self-directed professional who thrives in a fast-paced, evolving healthcare environment. Anticipates challenges, responds proactively to industry changes, and independently drives projects and initiatives forward. Project & Program Management – Successfully manages multiple priorities, projects, and deadlines while maintaining strong attention to detail, organization, and accountability. Educational & Content Development Skills – Ability to create engaging educational content and deliver impactful training through webinars, conference presentations, written publications, and digital platforms. Technology & Digital Communication Skills – Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Teams) and comfortable utilizing webinar platforms, social media, and other digital communication tools. Client Service Excellence – Committed to delivering responsive, high-quality service while fostering long-term client relationships and supporting client success. Active Listening & Collaboration – Listens attentively, values diverse perspectives, and works collaboratively to achieve organizational and client goals. Salary Range $100,000—$110,000 USD Compensation for this role is based on a variety of factors, including but not limited to, skills, experience, qualifications, location, and applicable employment laws. The expected salary range for this position reflects these considerations and may vary accordingly. In addition to base pay, eligible employees may have the opportunity to participate in company bonus programs. We also offer a comprehensive benefits package, including medical, dental, vision, 401(k), paid time off, and more. All official recruitment communications from Assembly Health will originate from an @assembly.health email address. Candidates are encouraged to carefully verify sender domains and remain vigilant against potential impersonation attempts. 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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. Prepare documentation for internal audits and inspections", "postedDate" : "2026-06-12T08:09:04.116", "createdAt" : "2026-06-12T08:09:03.870", "lastUpdated" : "2026-06-14T22:21:27.909", "ingestTimestamp" : "2026-06-12T08:09:03.870", "mongoId" : "6a2b975674d8ee00a0816d18", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "sourceUrl" : "https://medtronic.wd1.myworkdayjobs.com/RedeploymentMedtronicCareers/job/Buenos-Aires-Ciudad-Autnoma-de-Buenos-Aires-Argentina/Regulatory-Affairs-Specialist--Argentina_R67027", "salaryBand" : "200k+", "hasSalary" : false, "allSkills" : [ "Regulatory filing", "Validation", "Modification", "Registration", "Audit", "CAPA", "Leadership", "Regulatory Affairs", "Medical Devices", "Argentina Regulations", "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", "Medical devices", "Argentinian regulations", "COFEPRIS", "ANMAT", "DIGEMID", "Good Practices", "ISO 13485", "GMP", "GDP" ], "skillCount" : 35, "jobCategory" : "other", "seniorityLevel" : "mid", "dataQualityScore" : 0.8888889, "_score" : 992.73224, "daysOld" : 2, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Healthcare" }, { "id" : "6a2cb20f74d8ee00a09df900", "title" : "Regulatory Affairs Consultant- Regulatory Partner Responsible", "industry" : "Legal", "salary" : { "min" : 2500000.0, "max" : 4000000.0, "currency" : "INR", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "The estimation is based on the senior regulatory affairs consultant role in the biotech industry in India, adjusted for seniority and industry specifics." }, "location" : "India", "locations" : [ "India" ], "timestamp" : "2026-06-15T23:48:27.804", "fingerprint" : "0e583dd9cf15eab20f3aa2fb0377e5cd9d953b41505aedc78b4f9b986be0c865", "source" : "lever", "language" : "en", "applyUrl" : "https://jobs.lever.co/jobgether/6a3dbeb8-0afb-4654-af21-274196189273/apply", "externalId" : "6a3dbeb8-0afb-4654-af21-274196189273", "industryFunction" : { }, "structuredLocations" : [ { "country" : "India", "continent" : "as", "workMode" : "onsite" } ], "locationText" : "India", "employmentType" : "FULL_TIME", "minimumEducation" : "Bachelor's", "experienceMinYears" : 5, "experienceMaxYears" : 10, "experienceLevel" : "Senior", "professionalSkills" : [ "Partner management", "Vendor management", "Stakeholder management", "Process improvements" ], "hardSkillsList" : [ "Regulatory affairs", "Compliance tracking", "Performance indicators" ], "softSkillsList" : [ "Influencing" ], "hardSkills" : [ { "name" : "Regulatory affairs", "level" : "intermediate" }, { "name" : "Compliance tracking", "level" : "intermediate" }, { "name" : "Performance indicators", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Influencing" } ], "majorSkills" : "Regulatory affairs, Compliance oversight, Partner governance", "majorSkillsList" : [ "Regulatory affairs", "Compliance oversight", "Partner governance" ], "coreResponsibilities" : "Provide oversight of regulatory partner activities, Ensure compliance with local regulations, Ensure compliance with internal standards, Ensure compliance with governance frameworks, Monitor partner performance against KPIs, Identify deviations in partner performance, Drive corrective actions, Drive preventive actions, Act as primary contact for escalations, Act as primary contact for issue resolution, Act as primary contact for governance, Ensure alignment with local regulatory requirements, Communicate regulatory updates to internal teams, Communicate regulatory updates to cross-functional teams, Support regional regulatory teams in planning, Support regional regulatory teams in preparing submissions, Maintain internal regulatory databases, Update internal regulatory databases, Ensure accuracy of compliance tracking, Ensure accuracy of performance indicators, Foster relationships with external partners, Ensure adherence to company regulatory expectations, Ensure adherence to company regulatory standards, Oversee training effectiveness for partners, Ensure compliance capability development, Ensure continuous improvement in compliance", "teamCollaboration" : "Cross-functional teams; Diverse stakeholders", "domainKnowledge" : "Regulatory frameworks; Compliance requirements; Quality systems; Life sciences regulations", "domainList" : [ "regulatory-frameworks", "compliance-requirements", "quality-systems", "life-sciences-regulations" ], "domainSpecificKnowledge" : [ "Regulatory frameworks", "Compliance requirements", "Quality systems", "Life sciences regulations" ], "communicationSkills" : "Communicate updates", "documentationSkills" : "Regulatory databases", "continuousLearning" : "Structured learning; Development opportunities", "problemSolvingSkills" : "Issue resolution; Risk identification; Root cause analysis", "outcomesObjectives" : "Improve regulatory quality; Improve healthcare outcomes", "qualificationsBasic" : "5+ years experience in Regulatory Affairs, 5+ years experience in compliance, 5+ years experience in governance, Proven experience in partner management, Proven experience in vendor management, Understanding of regulatory frameworks, Understanding of compliance requirements, Understanding of quality systems in life sciences, Ability to operate in a matrixed organization, Ability to operate with multiple stakeholders, Ability to operate with multiple priorities, Analytical mindset, Ability to identify risks, Ability to implement controls, Ability to drive process improvements", "qualificationsPreferred" : "Degree in Life Sciences preferred, Degree in Pharmacy preferred, Degree in related scientific discipline preferred", "remoteFriendly" : true, "workSiteFlexibility" : "Remote", "rawDescription" : "## Accountabilities Provide end-to-end oversight of regulatory partner activities, ensuring compliance with local regulations, internal standards, and governance frameworks. Monitor partner performance against defined KPIs, identifying deviations and driving timely corrective and preventive actions. Act as the primary point of contact for escalations, issue resolution, and governance related to external regulatory partners. Ensure alignment with evolving local regulatory requirements and communicate updates to internal GRA and cross-functional teams. Support regional regulatory teams in planning and preparing submissions in accordance with local business and regulatory needs. Maintain and update internal regulatory databases, ensuring accuracy of compliance tracking and performance indicators. Foster strong relationships with external partners while ensuring adherence to company regulatory expectations and standards. Oversee training effectiveness for partners, ensuring appropriate compliance capability development and continuous improvement. Requirements: 5+ years of experience in Regulatory Affairs, compliance, governance, or related roles within pharmaceutical, biotechnology, or healthcare industries. Proven experience in partner or vendor management, including oversight of third-party regulatory activities. Strong understanding of regulatory frameworks, compliance requirements, and quality systems in life sciences. Ability to operate effectively in a matrixed, global organization with multiple stakeholders and priorities. Strong communication, influencing, and stakeholder management skills across diverse cultural and functional environments. Analytical mindset with the ability to identify risks, implement controls, and drive process improvements. Degree in Life Sciences, Pharmacy, or a related scientific discipline preferred. Benefits: Opportunity to work in a global regulatory environment with high-impact responsibilities. Exposure to cross-regional regulatory strategy and partner governance frameworks. Strong career development opportunities within regulatory affairs and compliance functions. Collaborative, international work environment with diverse stakeholders. Competitive compensation package aligned with experience and expertise. Opportunity to contribute to improving regulatory quality and healthcare outcomes globally. Structured learning and development opportunities in regulatory systems and governance. ## 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 Consultant- Regulatory Partner Responsible. Skills: Regulatory affairs, Compliance oversight, Partner governance. Provide oversight of regulatory partner activities. Ensure compliance with local regulations", "postedDate" : "2026-06-08T06:16:12.750", "createdAt" : "2026-06-08T06:16:12.750", "lastUpdated" : "2026-06-15T23:48:27.804", "ingestTimestamp" : "2026-06-14T22:10:02.849", "mongoId" : "6a2cb20f74d8ee00a09df900", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "200k+", "hasSalary" : false, "allSkills" : [ "Regulatory affairs", "Compliance tracking", "Performance indicators", "Influencing", "Compliance oversight", "Partner governance", "Partner management", "Vendor management", "Stakeholder management", "Process improvements", "Regulatory frameworks", "Compliance requirements", "Quality systems", "Life sciences regulations" ], "skillCount" : 14, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Senior", "dataQualityScore" : 0.8888889, "_score" : 981.74054, "daysOld" : 7, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Biotech", "llmIndustryConfidence" : 0.95 }, { "id" : "693072a570f0b99d58ffb691", "title" : "Senior Lead, Regulatory Affairs, APAC", "company" : "Amazon Kuiper", "industry" : "Public Policy, alexa and amazon devices", "salary" : { "min" : 220000.0, "max" : 315000.0, "currency" : "AUD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market data for a Senior Lead, Regulatory Affairs, APAC in Sydney, Australia, adjusted for seniority, company size, and the technology industry." }, "location" : "Sydney, New South Wales, AUS", "locations" : [ "Sydney, New South Wales, AUS" ], "timestamp" : "2026-06-15T02:36:45.003", "fingerprint" : "73fb7d1248c5e0357989800e64f7760320799cfee1d8639734145ae7e456d68a", "source" : "amazon", "language" : "en", "applyUrl" : "https://account.amazon.com/jobs/3135613/apply", "externalId" : "2bd8a393-c06e-4275-b5aa-b111fcc6a617", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Sydney", "state" : "New South Wales", "country" : "Australia", "continent" : "oc", "source" : "llm", "workMode" : "onsite", "geo" : "-33.8698439,151.2082848" } ], "locationText" : "Sydney, New South Wales, Australia", "employmentType" : "FULL_TIME", "minimumEducation" : "Bachelor's", "experienceMinYears" : 5, "experienceMaxYears" : 10, "experienceLevel" : "Senior", "professionalSkills" : [ "Regulatory affairs", "Compliance strategy", "Advocacy", "Public policy", "Regulatory filings", "Communications regulation" ], "hardSkillsList" : [ "Communications regulation", "Regulatory compliance", "Export control laws", "Export Administration Regulations" ], "hardSkills" : [ { "name" : "Communications regulation", "level" : "intermediate" }, { "name" : "Regulatory compliance", "level" : "intermediate" }, { "name" : "Export control laws", "level" : "intermediate" }, { "name" : "Export Administration Regulations", "level" : "intermediate" } ], "majorSkills" : "Regulatory affairs, Compliance, APAC region, Telecommunications regulation", "majorSkillsList" : [ "Regulatory affairs", "Compliance", "APAC region", "Telecommunications regulation" ], "coreResponsibilities" : "Interface directly with regulators, Perform advocacy consistent with priorities, Develop and optimize mechanisms for filing, Ensure accurate and timely filing, Align with Regulatory, Compliance, Legal, Public Policy, and, Drive timely and accurate compliance filings, Address unique nature of operating as a CSP, Communicate with regulators on compliance matters, Shape national, regional and international regulations, Define and lead regulatory compliance agenda, Collaborate to shape rules and regulations, Enhance overall regulatory compliance strategy, Ensure alignment on country and regional basis, Anticipate bottlenecks, Communicate risks clearly to leaders, Escalate effectively, Remove blockers, Deliver results", "teamCollaboration" : "Align with Regulatory, Compliance, Legal, Public Policy; 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, "_score" : 965.43646, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Telecommunications" }, { "id" : "6a2c8d9f74d8ee00a097978a", "title" : "Director, Regulatory Affairs, Commercial (Advertising & Promotion)", "company" : "Xenon Pharmaceuticals", "industry" : "Clinical Development", "salary" : { "min" : 224600.0, "max" : 248400.0, "currency" : "USD", "frequency" : "Yearly" }, "location" : "Boston", "locations" : [ "Boston" ], "timestamp" : "2026-06-15T08:16:07.180", "fingerprint" : "051d937a0579547caca5be8f7d855338cc031940d375741212a1ac473acb0e57", "source" : "ashby", "language" : "en", "applyUrl" : "https://jobs.ashbyhq.com/xenon/75abced6-0750-4a48-ac32-b86245a9c5e9/application", "externalId" : "75abced6-0750-4a48-ac32-b86245a9c5e9", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Boston", "state" : "Massachusetts", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "hybrid", "geo" : "42.3588336,-71.0578303" }, { "city" : "Pawtucket", "state" : "Rhode Island", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "hybrid", "geo" : "41.8789531,-71.3821203" } ], "locationText" : "Boston, Massachusetts, United States; Pawtucket, Rhode Island, United States", "employmentType" : "FULL_TIME", "minimumEducation" : "Bachelor's", "experienceMinYears" : 10, "experienceLevel" : "Director", "professionalSkills" : [ "Regulatory strategy", "Risk management", "Legal analysis", "Compliance oversight", "Problem-solving" ], "hardSkillsList" : [ "Regulatory affairs", "Promotional material review", "Clinical trial design", "Clinical data interpretation" ], "softSkillsList" : [ "Leadership", "Interpersonal skills" ], "hardSkills" : [ { "name" : "Regulatory affairs", "level" : "intermediate" }, { "name" : "Promotional material review", "level" : "intermediate" }, { "name" : "Clinical trial design", "level" : "intermediate" }, { "name" : "Clinical data interpretation", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Leadership" }, { "name" : "Interpersonal skills" } ], "majorSkills" : "Regulatory affairs, Advertising promotion, FDA regulations", "majorSkillsList" : [ "Regulatory affairs", "Advertising promotion", "FDA regulations" ], "coreResponsibilities" : "Provide strategic regulatory advice, Review product promotion materials, Review disease state education materials, Review pipeline materials, Review Medical materials, Provide strategic regulatory support, Generate innovative solutions, Develop internal cross-functional relationships, Monitor regulatory environment, Interpret new regulations, Interpret guidance documents, Interpret enforcement activities, Maintain in-depth understanding, Communicate complex issues, Establish relationship with OPDP, Provide oversight of promotional material review, Ensure on-time submission, Ensure accurate submission, Assist with training employees, Develop process efficiencies, Improve process efficiencies, Act in accordance with Company policies, Ensure policies are understood, Ensure policies are followed", "teamCollaboration" : "Cross-functional relationships; 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. Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.", "summaryDescription" : "Director, Regulatory Affairs, Commercial (Advertising & Promotion) at Xenon Pharmaceuticals. Skills: Regulatory affairs, Advertising promotion, FDA regulations. Provide strategic regulatory advice. Review product promotion materials", "createdAt" : "2026-06-13T22:16:57.565", "lastUpdated" : "2026-06-15T08:16:07.180", "ingestTimestamp" : "2026-06-13T22:16:57.565", "mongoId" : "6a2c8d9f74d8ee00a097978a", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 224600, "salaryAnnualMax" : 248400, "salaryBand" : "200k+", "hasSalary" : true, "allSkills" : [ "Regulatory affairs", "Promotional material review", "Clinical trial design", "Clinical data interpretation", "Leadership", "Interpersonal skills", "Advertising promotion", "FDA regulations", "Regulatory strategy", "Risk management", "Legal analysis", "Compliance oversight", "Problem-solving", "Biopharmaceutical industry", "Neuroscience", "Ion channel biology", "Prescription drug promotion" ], "skillCount" : 17, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Director", "dataQualityScore" : 0.8888889, "_score" : 964.5785, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Biotech", "llmIndustryConfidence" : 0.98 }, { "id" : "6a307677f292fd229c01a18c", "title" : "Regulatory Specialist IV", "company" : "Resource Environmental Solutions LLC", "salary" : { "min" : 102000.0, "max" : 125000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : false }, "location" : "West Coast", "locations" : [ "West Coast" ], "timestamp" : "2026-06-16T12:16:16.807", "fingerprint" : "9fac91a9c8dfae8860abfe1147b18376a7df39d34047af468ac39bb9e93d9114", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.greenhouse.io/res/jobs/5263273008", "externalId" : "5263273008", "industryFunction" : { }, "structuredLocations" : [ { "country" : "United States", "continent" : "na", "workMode" : "onsite" } ], "locationText" : "United States", "experienceMinYears" : 5, "experienceMaxYears" : 10, "experienceLevel" : "Senior", "remoteFriendly" : true, "rawDescription" : "At RES, we’re looking for purpose-driven individuals who are passionate about restoration and sustainability, and who want their work to make a lasting environmental impact. Our team members go above and beyond, bringing initiative, integrity, and a strong work ethic to every project. Collaboration is key—we thrive on teamwork, open communication, and diverse perspectives. In a field that constantly changes, we value those who are resilient, adaptable, and resourceful in the face of challenges. If you're intellectually curious, eager to learn, and ready to help restore ecosystems and protect natural resources, you’ll find your place here. RES is seeking a Regulatory Specialist IV with deep environmental permitting expertise to support restoration, mitigation, and environmental project delivery in California. This role is ideal for a senior regulatory professional who understands how to navigate complex agency requirements, prepare and review high-quality permit documents, evaluate project risk, and serve as a trusted technical resource for project teams, clients, and regulatory partners. The Regulatory Specialist IV will lead and support environmental permitting efforts across multiple project phases, from early feasibility and proposal support through project development, agency coordination, implementation, compliance, and closeout. This position requires strong technical judgment, excellent communication skills, and the ability to translate regulatory requirements into practical project strategies. Why You’ll Love This Job You will play a key role in advancing meaningful ecological restoration and mitigation projects across California. Your work will directly support project feasibility, regulatory approvals, compliance, and long-term project success. You’ll collaborate with interdisciplinary teams, including scientists, engineers, project managers, client solutions professionals, and field staff, while serving as a senior regulatory resource across complex projects. This is a great opportunity for someone who enjoys solving regulatory challenges, building productive agency relationships, mentoring others, and helping shape project strategy. Your Day-to-Day In this role, you will: Independently prepare, review, and support environmental permit applications, permit documents, regulatory reports, and agency submittals. Lead regulatory strategy for projects involving California permitting requirements and key federal and state regulations. Support permitting related to regulations such as CWA 404/401, CDFW 2081/1600, CEQA, NWP/IP, NPDES, ESA, the 2008 Mitigation Rule, and other applicable environmental requirements. Coordinate with regulatory agencies, clients, consultants, and internal project teams to move projects through permitting and approval processes. Analyze field data, identify project impacts and benefits, site regulatory constraints, and permitting requirements to support project decisions. Review and interpret maps, design plans, drawings, technical reports, and project documents. Develop schedules, communicate expectations, and coordinate timely completion of regulatory deliverables. Produce clear, accurate technical documents and review or edit technical documents prepared by others. Support field data collection, sampling protocols, QA/QC, and field documentation as needed. Provide technical guidance and mentorship to junior and mid-level staff. Communicate project risks, regulatory requirements, and recommended approaches to project teams and leadership. Support client communication, public presentations, and agency meetings as needed. We’d Love to Talk to You If You Have Many of the Following Bachelor’s degree in natural sciences, physical sciences, environmental science, law, environmental policy or a related field. 10+ years of relevant environmental or regulatory experience, or 8+ years of experience with an advanced degree. Expertise preparing and submitting environmental permit documents in California. Advanced understanding of environmental regulations, permits, agency approvals, and regulatory compliance requirements (e.g., CWA 404/401, CDFW 2081/1600, CEQA, NWP/IP, NPDES, ESA, 2008 Mitigation Rule). Working relationships with regulatory agencies and the ability to navigate agency expectations. Strong technical writing, document review, and regulatory reporting experience. Proficiency in field data collection, sampling protocols, and QA/QC procedures. Advanced knowledge in at least one environmental discipline and intermediate knowledge in several others, such as local and regional flora and fauna, hydrology, threatened and endangered species, soils, wetlands, stream morphology, water quality, environmental contamination, geology, ecology, biology, fisheries, or similar scientific disciplines GIS experience and the ability to work with maps, spatial data, and GIS-based project information. Ability to interpret design plans, project drawings, maps, and technical documents. What Will Make You Stand Out Advanced degree in a relevant scientific, environmental, policy, or legal discipline. Strong existing relationships with California regulatory agencies. Experience leading complex permitting strategies for restoration, mitigation, infrastructure, renewable energy, or environmental compliance projects. You Will Thrive in This Job If You Are A clear communicator who can explain complex regulatory issues to technical teams, clients, agencies, and non-technical stakeholders. A strategic thinker who understands how permitting decisions affect project feasibility, schedule, budget, compliance, and long-term success. Detail-oriented and committed to producing accurate, high-quality work products. Comfortable leading teams, coordinating across disciplines, and helping others stay aligned on priorities and deliverables. Able to balance independent technical judgment with collaboration and input from project teams. Proactive in identifying risks, constraints, and opportunities early in the project lifecycle. California Pay Range $102,000—$125,000 USD Please note that the “Day in the Life” section is not intended to be an exhaustive list of job duties, but rather a representative snapshot of typical responsibilities and work experiences at RES. RES is an Equal Opportunity Employer and a VEVRAA Federal Contractor. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.", "summaryDescription" : "Regulatory Specialist IV at Resource Environmental Solutions LLC", "postedDate" : "2026-06-16T01:17:41.106", "createdAt" : "2026-06-16T01:17:41.106", "lastUpdated" : "2026-06-16T12:16:16.807", "ingestTimestamp" : "2026-06-16T01:17:41.106", "mongoId" : "6a307677f292fd229c01a18c", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 102000, "salaryAnnualMax" : 125000, "salaryBand" : "100k-150k", "hasSalary" : true, "allSkills" : [ ], "skillCount" : 0, "jobCategory" : "engineering", "jobSubcategory" : "software", "seniorityLevel" : "Senior", "dataQualityScore" : 0.7777778, "_score" : 962.771, "daysOld" : 0, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Environmental Services", "llmIndustryConfidence" : 0.95 }, { "id" : "6a2a5ca074d8ee00a061551f", "title" : "Regulatory Affairs Intern", "company" : "EnergyHub", "industry" : "Energy", "salary" : { "min" : 24.0, "max" : 25.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : false }, "location" : "Brooklyn, New York", "locations" : [ "Brooklyn", "New York" ], "timestamp" : "2026-06-14T22:16:31.405", "fingerprint" : "a9daa04b0d1993e56837022d277622c1ee5fccc80a0d10b5abfa01dc3ef675f1", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.greenhouse.io/energyhub/jobs/8562493002", "externalId" : "8562493002", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Brooklyn", "state" : "New York", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "40.6526006,-73.9497211" } ], "locationText" : "Brooklyn, New York, United States", "employmentType" : "INTERNSHIP", "experienceMinYears" : 0, "experienceMaxYears" : 2, "experienceLevel" : "Entry", "professionalSkills" : [ "Policy strategy", "Regulatory strategy" ], "hardSkillsList" : [ "Research" ], "softSkillsList" : [ "Analytical thinking" ], "hardSkills" : [ { "name" : "Research", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Analytical thinking" } ], "majorSkills" : "Regulatory affairs, Clean energy policy", "majorSkillsList" : [ "Regulatory affairs", "Clean energy policy" ], "coreResponsibilities" : "Support policy work, Support regulatory strategy, Contribute to research, Contribute to strategy development, Share cross-functional information", "teamCollaboration" : "Cross-functional information sharing", "domainKnowledge" : "Distributed energy resources; Virtual power plants; Grid modernization", "domainList" : [ "distributed-energy-resources", "virtual-power-plants", "grid-modernization" ], "domainSpecificKnowledge" : [ "Distributed energy resources", "Virtual power plants", "Grid modernization" ], "remoteFriendly" : false, "rawDescription" : "About EnergyHub EnergyHub is a leading provider of distributed energy resource (DER) management solutions that help utilities unlock the full potential of virtual power plants (VPPs). 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. Support regulatory strategy", "postedDate" : "2026-06-11T21:29:39.029", "createdAt" : "2026-06-11T21:29:39.029", "lastUpdated" : "2026-06-14T22:16:31.405", "ingestTimestamp" : "2026-06-11T21:29:39.029", "mongoId" : "6a2a5ca074d8ee00a061551f", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 49920, "salaryAnnualMax" : 52000, "salaryBand" : "30k-50k", "hasSalary" : true, "allSkills" : [ "Research", "Analytical thinking", "Regulatory affairs", "Clean energy policy", "Policy strategy", "Regulatory strategy", "Distributed energy resources", "Virtual power plants", "Grid modernization" ], "skillCount" : 9, "jobCategory" : "sales", "jobSubcategory" : "sales", "dataQualityScore" : 1.0, "_score" : 957.6759, "daysOld" : 3, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Energy" }, { "id" : "6a2c7de674d8ee00a0951298", "title" : "Senior Associate – Regulatory Affairs (EU-OTC)", "company" : "ClinChoice", "industry" : "Pharma", "salary" : { "min" : 1500000.0, "max" : 2500000.0, "currency" : "INR", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Senior Associate – Regulatory Affairs in India, adjusted for mid-seniority, pharma industry, and company size." }, "location" : "India", "locations" : [ "India" ], "timestamp" : "2026-06-15T07:40:41.607", "fingerprint" : "0c365df45657c3f5697e3cf5573b07095ff6a6a2405e6f56b66a06e928917f4d", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.eu.greenhouse.io/clinchoice/jobs/4896340101", "externalId" : "4896340101", "industryFunction" : { }, "structuredLocations" : [ { "country" : "India", "continent" : "as", "workMode" : "onsite" } ], "locationText" : "India", "minimumEducation" : "Bachelor's", "experienceMinYears" : 4, "experienceMaxYears" : 5, "experienceLevel" : "Senior", "professionalSkills" : [ "Risk management", "Legal analysis", "Compliance oversight" ], "hardSkillsList" : [ "Regulatory affairs", "Submission management", "Regulatory documentation", "Regulatory review", "Regulatory action items", "License tracking", "Consolidated CFI review", "Aggregate report review" ], "softSkillsList" : [ "Critical thinking" ], "hardSkills" : [ { "name" : "Regulatory affairs", "level" : "intermediate" }, { "name" : "Submission management", "level" : "intermediate" }, { "name" : "Regulatory documentation", "level" : "intermediate" }, { "name" : "Regulatory review", "level" : "intermediate" }, { "name" : "Regulatory action items", "level" : "intermediate" }, { "name" : "License tracking", "level" : "intermediate" }, { "name" : "Consolidated CFI review", "level" : "intermediate" }, { "name" : "Aggregate report review", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Critical thinking" } ], "majorSkills" : "Regulatory affairs, Submission support, Renewal support, CFI support", "majorSkillsList" : [ "Regulatory affairs", "Submission support", "Renewal support", "CFI support" ], "coreResponsibilities" : "Support submission management, Support registration of OTC drugs, Compile submission packages, Prepare cover letter, Prepare application form, Prepare Module 1 documents, Compile regulatory documentation, Manage regulatory action items, Map regulatory inputs, Coordinate regulatory inputs, Plan regulatory timing, Develop project implementation plans, Manage workload planning, Ensure on-time completion, Review submission documents, Verify submission packages, Update submission trackers, Track licenses, Track approval validity, Track renewal timelines, Plan renewal submission, Coordinate renewal documentation, Submit renewal to health authority, Perform post submission activity, Review consolidated CFI, Edit consolidated CFI, Apply critical thinking, Apply common sense, Ensure regulatory actions fit purpose, Write regulatory actions, Copy regulatory actions into report, Challenge LOC contributions, Review regulatory contribution, Submit PSUSA, Follow PSUSA until completion, Submit post PSUSA variations", "teamCollaboration" : "Regional RA team; Cross-functional teams; Local RA lead; Cross-functional team", "projectManagementSkills" : [ "Workload planning" ], "domainKnowledge" : "EU-OTC drugs; EMEA regulations; PSUSA submissions", "domainList" : [ "eu-otc-drugs", "emea-regulations", "psusa-submissions" ], "domainSpecificKnowledge" : [ "EU-OTC drugs", "EMEA regulations", "PSUSA submissions" ], "toolProficiency" : [ "J tracker", "HAQ tracker", "PSMF tracker" ], "communicationSkills" : "Prepare cover letter; Prepare application form", "documentationSkills" : "Regulatory documentation; Module 1 documents; Aggregate report", "problemSolvingSkills" : "Critical thinking", "outcomesObjectives" : "Ensure on-time completion of projects; Ensure on-time completion of tasks", "qualificationsBasic" : "B.S. Chemistry, B.S. Biology, 4 years experience, 5 years experience, Regulatory Affairs experience", "rawDescription" : "Submission support: Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc. Support for the registration of OTC drugs in EU countries. Support regional RA team to compile submission packages. Prepare cover letter, application form and relevant Module 1 documents for variations. Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA. Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing. Work with regional regulatory team to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks. Regulatory review of submission documents for compliance. 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. Chemistry, Biology, or related fields Minimum of 4 ~ 5 years of experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience and specific interactions with a Regulatory Affairs Department by providing source documentation to CMC, Quality, or Regulatory Operations.", "summaryDescription" : "Senior Associate – Regulatory Affairs (EU-OTC) at ClinChoice. Skills: Regulatory affairs, Submission support, Renewal support, CFI support. Support submission management. Support registration of OTC drugs", "postedDate" : "2026-06-13T21:04:52.153", "createdAt" : "2026-06-13T21:04:52.153", "lastUpdated" : "2026-06-15T07:40:41.607", "ingestTimestamp" : "2026-06-13T21:04:52.153", "mongoId" : "6a2c7de674d8ee00a0951298", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "200k+", "hasSalary" : false, "allSkills" : [ "Regulatory affairs", "Submission management", "Regulatory documentation", "Regulatory review", "Regulatory action items", "License tracking", "Consolidated CFI review", "Aggregate report review", "Critical thinking", "Submission support", "Renewal support", "CFI support", "Risk management", "Legal analysis", "Compliance oversight", "Workload planning", "EU-OTC drugs", "EMEA regulations", "PSUSA submissions", "J tracker", "HAQ tracker", "PSMF tracker" ], "skillCount" : 22, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Mid", "dataQualityScore" : 0.8888889, "_score" : 949.9194, "daysOld" : 1, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Pharma", "llmIndustryConfidence" : 0.95 }, { "id" : "6a2cb20f74d8ee00a09df901", "title" : "Regulatory Affairs Pharmacovigilance Manager", "industry" : "Legal", "salary" : { "min" : 135000.0, "max" : 195000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Manager in the Pharma industry in the United States, adjusted for seniority and remote work." }, "location" : "US", "locations" : [ "US" ], "timestamp" : "2026-06-15T23:59:41.892", "fingerprint" : "910038b654858e35cf0a2b5ba2a66dc1e4eb9eb2092ce2c18a2d4e36199085c6", "source" : "lever", "language" : "en", "applyUrl" : "https://jobs.lever.co/jobgether/a66f7ac6-7a4d-4b3e-bebd-87260e75a737/apply", "externalId" : "a66f7ac6-7a4d-4b3e-bebd-87260e75a737", "industryFunction" : { }, "structuredLocations" : [ { "country" : "United States", "continent" : "na", "workMode" : "remote" } ], "locationText" : "United States", "employmentType" : "FULL_TIME", "minimumEducation" : "Bachelor's", "experienceMinYears" : 5, "experienceLevel" : "Manager", "professionalSkills" : [ "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" ], "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, "_score" : 948.6148, "daysOld" : 3, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Pharma", "llmIndustryConfidence" : 0.95 }, { "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, "_score" : 926.5329, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "E-Commerce", "llmIndustryConfidence" : 0.95 }, { "id" : "6a2a7bcf74d8ee00a06646d4", "title" : "Regulatory Affairs Director", "company" : "myTomorrows", "industry" : "Operations", "salary" : { "min" : 130000.0, "max" : 195000.0, "currency" : "EUR", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Director of Regulatory Affairs in the Biotech industry in Amsterdam, Netherlands, adjusted for seniority and company size." }, "location" : "Amsterdam HQ", "locations" : [ "Amsterdam HQ" ], "timestamp" : "2026-06-13T08:55:22.340", "fingerprint" : "7ca83b6d27f18d424109a48c4aed727e0af48ee86ccd414994e3269808261096", "source" : "ashby", "language" : "en", "applyUrl" : "https://jobs.ashbyhq.com/myTomorrows/2dcce001-4313-4c50-b430-c9e259963e4b/application", "externalId" : "2dcce001-4313-4c50-b430-c9e259963e4b", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Amsterdam", "country" : "Netherlands", "continent" : "eu", "source" : "llm", "workMode" : "onsite", "geo" : "52.3730796,4.8924534" } ], "locationText" : "Amsterdam, Netherlands", "employmentType" : "FULL_TIME", "minimumEducation" : "Advanced degree", "experienceLevel" : "Director", "professionalSkills" : [ "Regulatory strategy", "Program delivery", "Portfolio management", "Risk management", "Quality assurance", "Client engagement" ], "hardSkillsList" : [ "Regulatory affairs", "Global regulatory frameworks", "EAP", "Clinical trials", "Real-world data" ], "softSkillsList" : [ "Leadership" ], "hardSkills" : [ { "name" : "Regulatory affairs", "level" : "intermediate" }, { "name" : "Global regulatory frameworks", "level" : "intermediate" }, { "name" : "EAP", "level" : "intermediate" }, { "name" : "Clinical trials", "level" : "intermediate" }, { "name" : "Real-world data", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Leadership" } ], "coreResponsibilities" : "Translate company and RA/PV strategy into regulatory plans, Drive implementation across EAPs, Drive implementation across Clinical Trials, Drive implementation across Real-World Data initiatives, Oversee multiple regulatory programs, Ensure delivery against timelines, Ensure delivery against quality standards, Ensure delivery against client expectations, Identify and manage cross-program risks, Identify and manage dependencies, Identify and manage resource constraints, Lead Regulatory Affairs Managers, Coach Regulatory Affairs Managers, Develop Regulatory Affairs Managers, Lead senior team members, Coach senior team members, Develop senior team members, Set clear expectations for performance, Drive accountability for performance, Set clear expectations for quality, Drive accountability for quality, Set clear expectations for delivery, Drive accountability for delivery, Partner with Program Management, Partner with Medical Affairs, Partner with Quality Assurance, Partner with Supply Chain, Ensure regulatory input is embedded, Drive standardization of regulatory processes, Drive consistency of regulatory processes, Drive scalability of regulatory processes, Identify improvement opportunities, Implement data-driven solutions, Act as senior point of contact for clients, Support client discussions, Support audits, Support regulatory interactions with Health Authorities, Ensure adherence to global regulatory requirements, Ensure adherence to internal processes, Support inspection readiness, Support audit preparedness", "teamCollaboration" : "Cross-functional teams; 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. 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. Translate company and RA/PV strategy into regulatory plans. 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, "_score" : 917.2514, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Health Tech" }, { "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, "_score" : 899.48914, "daysOld" : 3, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Healthcare" }, { "id" : "6a2e9f7474d8ee00a0e3eb69", "title" : "Associate General Counsel, Regulatory Affairs", "company" : "Jackson", "industry" : "Legal", "salary" : { "min" : 225000.0, "max" : 350000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Senior Associate General Counsel in the Insurance industry in Lansing, United States, adjusted for company size and seniority." }, "location" : "Lansing, MI", "locations" : [ "Lansing, MI", "United States of America" ], "timestamp" : "2026-06-16T04:58:46.162", "fingerprint" : "80fa88d3eaf68222115ffe1a42c596c75a6d65c0c1556653a4ebea6a68bfcc0c", "source" : "workday", "language" : "en", "applyUrl" : "https://jackson.wd1.myworkdayjobs.com/Jackson_Careers/job/Lansing-MI/Associate-General-Counsel--Regulatory-Affairs_REQ-03814", "externalId" : "REQ-03814", "industryFunction" : { }, "locationPoint" : "42.48424,-76.47994", "structuredLocations" : [ { "city" : "Lansing", "state" : "Michigan", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "42.7338254,-84.5546295" } ], "locationText" : "Lansing, Michigan, United States", "employmentType" : "FULL_TIME", "minimumEducation" : "Juris Doctor", "experienceMinYears" : 8, "experienceMaxYears" : 10, "experienceLevel" : "Senior", "remoteFriendly" : false, "rawDescription" : "**_If you are an internal associate, please login to Workday and apply through Jobs Hub._** ## **_Job Purpose_** ## The Associate General Counsel, Regulatory Affairs provides advice to internal departments on a wide range of legal issues. 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. Company facilities and campuses are tobacco-free environments.", "summaryDescription" : "Associate General Counsel, Regulatory Affairs at Jackson", "postedDate" : "2026-06-12T21:26:49.309", "createdAt" : "2026-06-14T21:26:49.294", "lastUpdated" : "2026-06-16T04:58:46.162", "ingestTimestamp" : "2026-06-14T21:26:49.294", "mongoId" : "6a2e9f7474d8ee00a0e3eb69", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "sourceUrl" : "https://jackson.wd1.myworkdayjobs.com/Jackson_Careers/job/Lansing-MI/Associate-General-Counsel--Regulatory-Affairs_REQ-03814", "salaryAnnualMin" : 225000, "salaryAnnualMax" : 350000, "salaryBand" : "200k+", "hasSalary" : true, "allSkills" : [ ], "skillCount" : 0, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "mid", "dataQualityScore" : 0.8888889, "_score" : 897.7243, "daysOld" : 3, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Insurance", "llmIndustryConfidence" : 0.98 }, { "id" : "69ce5e219bc74574cb6754b2", "title" : "Regulatory Analyst", "company" : "The Cincinnati Insurance Companies", "industry" : "Insurance", "salary" : { "min" : 19.0, "max" : 20.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : false }, "location" : "Claims - Operations Regulatory Analyst", "locations" : [ "Claims - Operations Regulatory Analyst", "163566", "false, 163566, false" ], "timestamp" : "2026-06-15T09:26:16.805", "fingerprint" : "c10e01e31922805a966dccccb7896247e8e6275f70835980052fe61ce445ae4a", "source" : "taleo", "language" : "en", "applyUrl" : "https://cinfin.taleo.net/careersection/ex/jobdetail.ftl?job=163566", "externalId" : "163566", "industryFunction" : { }, "structuredLocations" : [ { "city" : "dorowa mining lease", "state" : "manicaland", "country" : "Zimbabwe", "continent" : "africa", "source" : "locations-index", "geo" : "-19.06667,31.75" } ], "employmentType" : "FULL_TIME", "minimumEducation" : "High School", "domainKnowledge" : "Claims Financials; IRS system; Business processes", "domainList" : [ "claims-financials", "irs-system", "business-processes" ], "domainSpecificKnowledge" : [ "Claims Financials", "IRS system", "Business processes" ], "continuousLearning" : "Lifelong learning approach; Continuous education", "remoteFriendly" : false, "rawDescription" : "Make a difference with a career in insurance At The Cincinnati Insurance Companies, we put people first and apply the Golden Rule to our daily operations. To put this into action, we’re looking for extraordinary people to join our talented team. Our service-oriented, ethical, knowledgeable, caring associates are the heart of our vision to be the best company serving independent agents. We help protect families and businesses as they work to prevent or recover from a loss. Share your talents to help us reach for continued success as we bring value to the communities we serve and demonstrate that Actions Speak Louder in Person®. If you’re ready to build productive relationships, collaborate within a diverse team, embrace challenges and develop your skills, then Cincinnati may be the place for you. We offer career opportunities where you can contribute and grow. Start your journey with us Headquarters Claims Operations is currently seeking Claims Ops Regulatory Analyst to provide financial, administrative, and clerical services to ensure effective, efficient, and accurate financial and administrative operations in the Claims Financial unit. The pay range for this position is $19.00- $20.00 hourly. The pay determination is based on the applicant’s education, experience, location, knowledge, skills, and abilities. Eligible associates may also receive an annual cash bonus and individual performance. Be Ready to: run- TIN match in the IRS system update BP information in CMS and Claim Center resolving uncashed checks approving Positive Pay assigning check stock log Claims Recovery Checks process Pay Runs contact vendors prepare Escheat/W9 letters for mailing maintain documentation on business processes provide customer support by answering Claims Financials inquires Be equipped with: organized and able to manage multiple tasks concurrently ability to establish priorities and meet deadlines effective written communications skills excellent interpersonal and team building skills analytical skills flexible and able to deal with changing priorities effective verbal and listening communication skills detail-oriented and problem-solving skills proficient with Microsoft Word and Excel decision making skills ability to work independently   open to continuous education You’ve earned: high school diplomas/GED Enhance your talents Providing outstanding service and developing strong relationships with our independent agents are hallmarks of our company. Whether you have experience from another carrier or you’re new to the insurance industry, we promote a lifelong learning approach. Cincinnati provides you with the tools and training to be successful and to become a trusted, respected insurance professional – all while enjoying a meaningful career. Enjoy benefits and amenities Your commitment to providing strong service, sharing best practices and creating solutions that impact lives is appreciated. To increase the well-being and satisfaction of our associates, we offer a variety of benefits and amenities. Learn more about our benefits and amenities packages.   Embrace a diverse team As a relationship-based organization, we welcome and value a diverse workforce. We grant equal employment opportunity to all qualified persons without regard to race; creed; color; sex, including sexual orientation; religion; national origin; age; disability; or any other basis prohibited by law. 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Explain decision making", "problemSolvingSkills" : "Resolving issues", "outcomesObjectives" : "Reach timely outcomes; Drive cases to timely outcomes", "qualificationsBasic" : "Experience of contentious litigation, Leading on complex investigations, Qualified solicitor or barrister, Significant PQE or post-Call experience, Previous people management/leadership experience, Proven evidence of monitoring/reviewing performance, Coaching and mentoring to support development, Delegating effectively, Responding to queries, Resolving issues, Motivating others to achieve high standards, Empowerment and trust, Experienced project manager, Portfolio management skills, Planning, Quality control, Budgeting, Forecasting costs and/or time", "qualificationsPreferred" : "Practising legal applicants", "remoteFriendly" : true, "workSiteFlexibility" : "Flexible", "rawDescription" : "**Job Title: Enforcement Investigations Team Manager (Practising Legal or Regulatory)** **Division:** Enforcement & Market Oversight **Department** : Retail & Regulatory Investigations (Retail 2) * **Salary:** Manager – Practising Legal - London £100,00 - £120,00 or Manager – Regulatory – London £90,000 - £110,000 (Salary offered will be based on skills and experience) * **This role is graded as:** Manager – Practising Legal or Manager - Regulatory * **Your recruitment contact is** Riley Fox via [Riley.Fox@fca.org.uk](mailto:Riley.Fox@fca.org.uk) Applications sent via social media or email will not be accepted. **_About the FCA and team_** We regulate financial services firms in the UK, to keep financial markets fair, thriving and effective. By joining us, you’ll play a key part in protecting consumers, driving economic growth, and shaping the future of UK finance services. Enforcement & Market Oversight (EMO) is responsible for the FCA’s responsibilities for market monitoring, delivery of the functions of the UK Listing Authority (UKLA) and the investigation and prosecution of misconduct using the whole spectrum of criminal, civil and administrative sanctions and remedies against firms and individuals. The Retail and Regulatory Investigations Directorate within Enforcement & Market Oversight (EMO) focuses on regulated firms and their management and how they engage with consumers. Cases cover a very wide range of issues including mis-selling, anti-bribery and corruption, fraud, money laundering, systems and controls failings, and corporate governance failures. We also cover a broad range of financial markets including cryptocurrencies, pensions, mortgages, general insurance, retail investment advice, retail and wholesale banking and consumer credit. The Enforcement investigation team manager is a critical role within EMO. You will be expected to provide leadership to a multi-disciplinary team, to develop the talent within that team, delegate responsibly, and to set clear standards for what your team produce and how it is produced. You will be responsible for managing a challenging portfolio of cases in an environment which is fast paced and dynamic. This is an exciting opportunity to lead a team delivering high-profile investigations, from evidence gathering and interviews through to settlement discussions and court engagement. You will be accountable for your team’s investigations, including acting as a witness in Tribunal or criminal proceedings where required. As a senior leader, you will drive cases to timely outcomes, build strong stakeholder relationships, and develop a multidisciplinary team of 8–12 investigators, while contributing to the strategic direction of EMO. **Role responsibilities** * Project Manager for a portfolio of cases, having day to day operational responsibility for the portfolio * Overseeing and managing the work of Lead Associates, Senior Associates, Associates and Investigation Case Support Officers and ensuring effective progression of projects and cases to reach timely outcomes, escalating issues to the Head of Department where necessary and managing external case costs and budgeting for the lifecycle of a case * Be accountable for the investigations to senior colleagues and be able to explain strategy and decision making clearly * Responsible for leading and managing a multidisciplinary team or around 8 to 12 investigators * Managing relationships with senior external stakeholders, including firms and their legal representatives, other relevant law enforcement or government agencies, and internal stakeholders including market oversight, supervisory areas, senior management and the press office * Line management responsibilities, including being responsible for direct reports' development and appraisals, and ensuring optimal performance by managing any cases of poor performance or conduct in a timely manner **Skills required** **Minimum:** * Experience of contentious litigation and/or leading on complex investigations * Qualified solicitor or barrister with significant PQE or post-Call experience in an area directly relevant to the role for practicing legal applicants * Previous people management/leadership experience, with proven evidence of monitoring/reviewing performance and coaching and mentoring to support development * Experience of leading the work of others including delegating effectively, responding to queries, resolving issues and motivating others to achieve high standards through empowerment and trust **Essential:** * Experienced project manager with strong portfolio management skills, including planning, quality control, budgeting and forecasting costs and/or time associated with a project * Ability to perform under pressure, managing competing priorities whilst delivering multiple outcomes to challenging deadline * Strong communication skills and the ability to present well-reasoned arguments in a clear and concise manner * Ability to exercise own judgement and defend those judgements where necessary and appropriate * Excellent relationship management skills and the ability to command respect and credibility internally and externally, including with firms' senior management and their legal representative * Ability to contribute to the strategy of the departmental management team and wider Division * Ability to work collaboratively and inclusively as part of a team, valuing different perspectives and backgrounds * Continuously seeking out new and more effective ways to conduct your work, and feeding this back to management ** _Benefits_** * 28 days annual leave plus bank holidays * Hybrid model where employees work a minimum of 40% in the office each month (expectation of 50% for senior leaders). Changing from September to a minimum of 50% in the office each month (expectation of 60% for Directors and Executive Directors) * Non-contributory pension (8–12% depending on age) and life assurance at eight times your salary * Private healthcare with Bupa, income protection, and 24/7 Employee Assistance * 35 hours of paid volunteering annually * A flexible benefits scheme designed around your lifestyle For a full list of our benefits, and our recruitment process as a whole visit [our benefits page](https://www.fca.org.uk/careers/experienced-professionals). **_Our values & culture_** Our colleagues are the key to our success as a regulator. We are committed to fostering a diverse and inclusive culture: one that’s free from discrimination and bias, celebrates difference, and supports colleagues to deliver at their best. We believe that our differences and similarities enable us to be a better organisation – one that makes better decisions, drives innovation, and delivers better regulation. If you require any adjustments due to a disability or condition, your recruiter is here to help - reach out for tailored support. We welcome diverse working styles and aim to find flexible solutions that suit both the role and individual needs, including options like part-time and job sharing where applicable. ** _Disability Confident: our hiring approach_** We’re proud to be a [Disability Confident Employer](https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fcollections%2Fdisability-confident-campaign&data=05%7C02%7CStephanie.Corker%40fca.org.uk%7C8055792d0d054cf29cf408ddb7e56815%7C551f9db3821c44578551b43423dce661%7C1%7C0%7C638868918099646424%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=oBu5OPmMia9nIWEI%2Fj9Y2ATUXy%2FkMTQ8bdw8UJzYc%2FY%3D&reserved=0), and therefore, people or individuals with disabilities and long-term conditions who best meet the minimum criteria for a role will go through to the next stage of the recruitment process. In cases of high application volumes, we may progress applicants whose experience most closely matches the role’s key requirements. ** _Useful information and timeline_** * Advert Closing: 24th June 2026 application will need to be submitted by 23:59 * CV Review/Shortlist: 25th June 2026 * 1st stage interviews: Week commencing 1st July 2026 * Manager Assessment: Week commencing 13th July 2026 * 2nd stage interviews: Week commencing 20th July 2026, please note that the interviews will be in person Your Recruiter will discuss the process in detail with you during screening for the role, therefore, please make them aware if you are going to be unavailable for any date during this time.", "summaryDescription" : "Manager - Regulatory or Practising Legal at FCA. Skills: Regulatory investigations, Case management, Team leadership. Provide leadership to a team. Develop talent within the team", "postedDate" : "2026-06-16T03:49:50.536", "createdAt" : "2026-06-16T03:49:50.521", "lastUpdated" : "2026-06-16T13:13:24.031", "ingestTimestamp" : "2026-06-16T03:49:50.521", "mongoId" : "6a305708f292fd229cf32d31", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "sourceUrl" : "https://fca.wd3.myworkdayjobs.com/FCA_Careers/job/London/Manager---Regulatory_JR0021737-1", "salaryBand" : "75k-100k", "hasSalary" : false, "allSkills" : [ "Contentious litigation", "Complex investigations", "Performance monitoring", "Case management", "Leadership", "Mentoring", "Regulatory investigations", "Team leadership", "Portfolio management", "Quality control", "Budgeting", "Forecasting", "Planning", "Retail and regulatory investigations", "Financial markets", "Cryptocurrencies", "Pensions", "Mortgages", "General insurance", "Retail investment advice", "Retail banking", "Wholesale banking", "Consumer credit", "Mis-selling", "Anti-bribery and corruption", "Fraud", "Money laundering", "Systems and controls failings", "Corporate governance failures", "UK Listing Authority" ], "skillCount" : 30, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "manager", "dataQualityScore" : 1.0, "_score" : 875.4184, "daysOld" : 0, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Government", "llmIndustryConfidence" : 0.98 }, { "id" : "6a2c7ac074d8ee00a0946a7a", "title" : "Clinical Regulatory Specialist", "company" : "Iterative Health", "industry" : "Healthcare", "salary" : { "min" : 65000.0, "max" : 85000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Junior Clinical Regulatory Specialist in Tyler, United States, adjusted for industry and company size." }, "location" : "Tyler, Texas, United States", "locations" : [ "Tyler", "Texas", "United States" ], "timestamp" : "2026-06-15T06:39:42.849", "fingerprint" : "9903aab9e3c815f3e910ca30bae387ebb31f30399bc20e860d33246b2cec561a", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.greenhouse.io/iterativehealth/jobs/4688098006", "externalId" : "4688098006", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Tyler", "state" : "Texas", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "32.3512601,-95.3010624" }, { "city" : "Cambridge", "state" : "Massachusetts", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "42.3656347,-71.1040018" }, { "city" : "New York", "state" : "New York", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "40.7127281,-74.0060152" } ], "locationText" : "Tyler, Texas, United States; Cambridge, Massachusetts, United States; New York, New York, United States", "experienceMinYears" : 2, "professionalSkills" : [ "Process management", "Cross-functional coordination", "Vendor management", "Stakeholder management", "Resource planning", "Continuous improvement", "Regulatory compliance", "Clinical trial management" ], "hardSkillsList" : [ "Regulatory document completion", "ISF filing", "Study correspondence", "IRB submissions", "Site audits" ], "hardSkills" : [ { "name" : "Regulatory document completion", "level" : "intermediate" }, { "name" : "ISF filing", "level" : "intermediate" }, { "name" : "Study correspondence", "level" : "intermediate" }, { "name" : "IRB submissions", "level" : "intermediate" }, { "name" : "Site audits", "level" : "intermediate" } ], "majorSkills" : "Clinical research, Regulatory affairs, Compliance, Clinical trials", "majorSkillsList" : [ "Clinical research", "Regulatory affairs", "Compliance", "Clinical trials" ], "coreResponsibilities" : "Assist research sites, Complete essential regulatory documents, File ISF, Manage study correspondence, Facilitate regulatory activity, Submit IRB applications, Participate in monitor visits, Participate in site audits, Serve as point of contact", "teamCollaboration" : "Internal stakeholders; Clinical sites; Study sponsors; CROs; Clinical site staff", "domainKnowledge" : "Gastroenterology; Hepatology; Clinical research industry; Phase 2-4 studies", "domainList" : [ "gastroenterology", "hepatology", "clinical-research-industry", "phase-2-4-studies" ], "domainSpecificKnowledge" : [ "Gastroenterology", "Hepatology", "Clinical research industry", "Phase 2-4 studies" ], "toolProficiency" : [ "CTMS" ], "communicationSkills" : "Effective communication", "documentationSkills" : "Regulatory document completion; ISF filing", "problemSolvingSkills" : "Decision-making; Prioritization", "qualificationsBasic" : "2+ years of relevant work experience, Clinical research coordinator experience, Site facing clinical regulatory experience, Experience in Phase 2-4 trials, Familiar with GCP, Familiar with FDA guidelines, Familiar with SOPs", "qualificationsPreferred" : "Previous experience using CTMS", "workSiteFlexibility" : "Onsite", "rawDescription" : "Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Clinical Regulatory Specialist Cambridge, Massachusetts, United States, New York, New York, United States Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Iterative Health is pioneering the use of artificial intelligence-based precision medicine in gastroenterology, with the aim of helping to optimize clinical trials. We use advanced machine learning and computer vision to interpret endoscopic videos along with other types of data, helping clinicians better assess patients with potential GI problems. Ultimately, the company aims to establish more meaningful endpoints to serve as better predictors of both therapeutic response and disease outcomes. This is an exciting time in the Clinical Research industry! Our team is driving the advancement of research by implementing streamlined processes, with a mission of getting treatment options to patients in a faster, more efficient way. Iterative Health is seeking a Clinical Regulatory Specialist to join our team. The Clinical Regulatory Specialist will work under the direction of a Clinical Regulatory Manager or Director with the primary responsibility of assisting research sites with the conduct and compliance of Phase 2-4 pharma sponsored research studies. This position will be a collaborative individual contributor, working with internal stakeholders, clinical sites, and study sponsors/CROs – requiring results-driven administrative and regulatory work. What you’ll be doing: Working alongside research sites on essential regulatory document completion, ISF filing, and study correspondence Facilitating clinical trial regulatory activity from study start-up through closeout IRB submissions on behalf of sites Participating in monitor visits and site level audits May serve as a primary point of contact for clinical site staff What we’re looking for: Experience in clinical research, regulatory, and compliance in Phase 2-4 sponsor initiated clinical trials Familiar with adhering to Good Clinical Practices (GCP), FDA guidelines, and Standard Operating Procedures (SOPs) Strong organizational, decision-making, time management, multi-tasking, and prioritization skills Ability to communicate effectively both internally and with external customers Previous experience using a clinical trial management system (CTMS) is preferred Requirements: 2+ years of relevant work experience Previous experience as a clinical research coordinator or a site facing clinical regulatory dedicated research role At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.", "summaryDescription" : "Clinical Regulatory Specialist at Iterative Health. Skills: Clinical research, Regulatory affairs, Compliance, Clinical trials. Assist research sites. 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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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Partner with Commercial Regulatory Affairs; Work in matrixed environments; Work in global environments", "domainKnowledge" : "Global regulatory frameworks; In-vitro diagnostics; Regulated life sciences", "domainList" : [ "global-regulatory-frameworks", "in-vitro-diagnostics", "regulated-life-sciences" ], "domainSpecificKnowledge" : [ "Global regulatory frameworks", "In-vitro diagnostics", "Regulated life sciences" ], "toolProficiency" : [ "Microsoft Office tools", "Regulatory documentation systems" ], "communicationSkills" : "Written communication; Verbal communication; Translate complex topics", "documentationSkills" : "Regulatory documentation; Regulatory assessments", "continuousLearning" : "Professional development", "problemSolvingSkills" : "Critically assess applicability; Critically assess impact", "qualificationsBasic" : "Bachelor's degree in biological sciences, biomedical engineering, chemistry, or related field with 9+ years of relevant experience, Master's degree with 7+ years of relevant experience, PhD with 4+ years of relevant experience, Understanding of global regulatory frameworks, Experience in regulatory affairs, Ability to develop clear, structured regulatory documentation, Cross-functional collaboration skills, Excellent written and verbal communication skills, Proficiency in Microsoft Office tools, Proficiency in regulatory documentation systems", "qualificationsPreferred" : "Experience in in-vitro diagnostics, Experience in highly regulated life sciences industries", "remoteFriendly" : true, "workSiteFlexibility" : "Flexible", "rawDescription" : "## Accountabilities Develop, implement, and execute global regulatory strategies ensuring compliance across product registration, lifecycle management, labeling, and promotional material governance. Oversee regulatory workflows and tools used to manage global product lifecycle activities, ensuring efficiency, consistency, and compliance. Define and maintain global labeling requirements and regulatory procedures, ensuring alignment with international regulations and internal standards. Review and govern marketing, advertising, promotional, and training materials (MAPSS) to ensure compliance with applicable regulatory requirements. Partner closely with Business Unit and Commercial Regulatory Affairs teams to align global strategies, share best practices, and drive cross-functional initiatives. Support regulatory readiness for internal and external audits, inspections, and global compliance assessments. Evaluate evolving global regulatory requirements and translate them into actionable guidance for stakeholders across the organization. Requirements Bachelor’s degree in biological sciences, biomedical engineering, chemistry, or related field with 9+ years of relevant experience; or Master’s degree with 7+ years; or PhD with 4+ years. Strong understanding of global regulatory frameworks, with the ability to critically assess applicability and impact on products and processes. Experience in regulatory affairs, ideally within in-vitro diagnostics or other highly regulated life sciences industries. Ability to develop clear, structured regulatory documentation, assessments, and stakeholder-ready presentations. Strong cross-functional collaboration skills, with experience working in matrixed and global environments. Excellent written and verbal communication skills, with the ability to translate complex regulatory topics into actionable business guidance. Proficiency in Microsoft Office tools and regulatory documentation systems. Strong leadership, influence, and decision-making abilities, with the capacity to drive alignment across diverse teams. Benefits Annual salary range: $140,000 – $170,000, plus bonus and incentive eligibility. Comprehensive benefits package including medical, dental, vision, and retirement (401k) plans. Paid time off and programs supporting overall well-being and work-life balance. Flexible remote work arrangement with the option to work from home. Opportunity to shape global regulatory frameworks within a highly innovative diagnostics environment. Exposure to international regulatory strategy, product lifecycle governance, and cross-functional leadership. Inclusive, collaborative culture focused on continuous improvement and professional development. ## 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" : "Staff Global Regulatory GPO. Skills: Regulatory strategy, Compliance oversight, Risk management, Legal analysis. Develop global regulatory strategies. 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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 filings", "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. 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, "_score" : 855.43353, "daysOld" : 3, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Healthcare" }, { "id" : "6a2c5e6674d8ee00a08e3c24", "title" : "Associate Director, Regulatory Strategy", "company" : "Beeline Medicines", "industry" : "Biotechnology", "salary" : { "min" : 215000.0, "max" : 305000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for Biotech industry in Boston, adjusted for Director seniority and full-time employment." }, "location" : "Boston, Massachusetts, United States", "locations" : [ "Boston", "Massachusetts", "United States" ], "timestamp" : "2026-06-15T00:48:04.344", "fingerprint" : "05ec4eaef8571f0c22df91bd69f22a4fad725bdb02ffa8925963d3c097a5078d", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.greenhouse.io/beelinemedicines/jobs/4217954009", "externalId" : "4217954009", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Boston", "state" : "Massachusetts", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "hybrid", "geo" : "42.3588336,-71.0578303" } ], "locationText" : "Boston, Massachusetts, United States", "minimumEducation" : "Bachelor's", "experienceLevel" : "Director", "professionalSkills" : [ "Regulatory strategy", "Regulatory affairs" ], "hardSkillsList" : [ "CTA filings" ], "softSkillsList" : [ "Adaptability" ], "hardSkills" : [ { "name" : "CTA filings", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Adaptability" } ], "majorSkills" : "Regulatory strategy, Regulatory affairs", "majorSkillsList" : [ "Regulatory strategy", "Regulatory affairs" ], "coreResponsibilities" : "Develop regulatory strategies, Implement regulatory strategies, Coordinate ex-US regulatory activities, Support ex-US regulatory interactions, Ensure consistency with regulatory strategy, Serve as regulatory representative, Ensure alignment on regulatory issues, Ensure alignment on regulatory risks, Ensure alignment on regulatory timelines, Communicate regulatory requirements, Communicate regulatory risks, Communicate regulatory opportunities, Partner with Medical Writing, Ensure regulatory compliance, Ensure quality across submission documents, Perform other duties as assigned", "teamCollaboration" : "Cross-functional program teams; Regional leads; CROs", "domainKnowledge" : "Autoimmune diseases; Inflammatory diseases; Immunology; Biologics; Large molecules", "domainList" : [ "autoimmune-diseases", "inflammatory-diseases", "immunology", "biologics", "large-molecules" ], "domainSpecificKnowledge" : [ "Autoimmune diseases", "Inflammatory diseases", "Immunology", "Biologics", "Large molecules" ], "communicationSkills" : "Synthesize complex information", "documentationSkills" : "Briefing document preparation; Submission documents", "qualificationsBasic" : "7 years regulatory affairs experience (Bachelors), 5 years regulatory affairs experience (Masters), 3 years regulatory affairs experience (Doctoral), Experience with Type meeting processes, Experience with briefing document preparation, Understanding of ICH guidelines, Understanding of 21 CFR Parts 312, Understanding of 21 CFR Parts 314/601, Understanding of international regulatory frameworks, Experience with biologics (mAbs, fusion proteins, large molecules), Comfort operating in ambiguous environments, Comfort operating in high-growth environments, Ability to build effective partnerships, Flexibility and adaptability, Commitment to integrity, Ability to work efficiently, Excellent written communication, Excellent verbal communication, Ability to synthesize complex regulatory information", "qualificationsPreferred" : "Advanced degree (MS, PhD, PharmD) preferred, Focused on regulatory strategy preferred", "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 Strategy is a key member of the Regulatory Affairs organization, responsible for developing and implementing regulatory strategies for the company's portfolio of therapeutics in Immunology coordinate ex-US regulatory activities with regional leads or CROs as appropriate. Support ex-US regulatory interactions, including EMA scientific advice and CTA filings, ensuring consistency with the overall regulatory strategy. Serve as the regulatory representative on cross-functional program teams, ensuring alignment on critical regulatory issues, risks, and timelines. Communicate regulatory requirements, risks, and opportunities clearly and proactively to non-regulatory stakeholders including Clinical, Biostatistics, and Medical Affairs. Partner with Medical Writing to ensure regulatory compliance and quality across submission documents. Perform other duties and responsibilities as assigned Qualifications: Education: Bachelor's degree in a life sciences, pharmacy, or related field required; advanced degree (MS, PhD, PharmD) strongly preferred. 7 years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry with bachelors degree, 5 years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry with Advance Masters Degree and/or 3 years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry with doctoral degree (PharmD / Ph.D). Strong desire of focused on regulatory strategy preferred. Demonstrated experience in I familiarity with Type B meeting processes and briefing document preparation. Strong understanding of ICH guidelines, 21 CFR Parts 312 and 314/601, and applicable international regulatory frameworks. Experience with biologics (mAbs, fusion proteins, or other large molecules) in an I comfort operating in ambiguous, high-growth environments. Building effective partnerships with flexibility and adaptability. Commitment to integrity and working efficiently to achieve key team and business outcomes. Excellent written and verbal communication skills; ability to synthesize complex regulatory information for varied audiences. 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 $192,000—$208,500 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 Strategy at Beeline Medicines. Skills: Regulatory strategy, Regulatory affairs. Develop regulatory strategies. Implement regulatory strategies", "postedDate" : "2026-06-12T21:54:59.977", "createdAt" : "2026-06-12T21:54:59.977", "lastUpdated" : "2026-06-15T00:48:04.344", "ingestTimestamp" : "2026-06-12T21:54:59.977", "mongoId" : "6a2c5e6674d8ee00a08e3c24", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 215000, "salaryAnnualMax" : 305000, "salaryBand" : "200k+", "hasSalary" : true, "allSkills" : [ "CTA filings", "Adaptability", "Regulatory strategy", "Regulatory affairs", "Autoimmune diseases", "Inflammatory diseases", "Immunology", "Biologics", "Large molecules" ], "skillCount" : 9, "jobCategory" : "other", "jobSubcategory" : "regulatory-&-quality", "dataQualityScore" : 0.8888889, "_score" : 852.5017, "daysOld" : 2, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Biotechnology" }, { "id" : "6a2ca57974d8ee00a09b6af6", "title" : "Director (Regulatory, Compliance & Risk)", "company" : "Alpha Financial Markets Consulting", "industry" : "Consulting", "salary" : { "min" : 125000.0, "max" : 185000.0, "currency" : "GBP", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for Director (Regulatory, Compliance & Risk) in Edinburgh, United Kingdom, adjusted for seniority and financial services industry." }, "location" : "Edinburgh, City Of Edinburgh, Scotland, United Kingdom", "locations" : [ "Edinburgh", "City Of Edinburgh", "Scotland", "United Kingdom", "London", "Greater London", "England", "United Kingdom" ], "timestamp" : "2026-06-16T02:01:01.497", "fingerprint" : "74eef3dd802b5f7911ddc7a2a562bf6474f3d4ef83cf6545d03f009766868e3f", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.greenhouse.io/alphafmcroles/jobs/5985032002", "externalId" : "5985032002", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Edinburgh", "state" : "City Of Edinburgh", "country" : "United Kingdom", "continent" : "eu", "source" : "llm", "workMode" : "onsite", "geo" : "55.9519018,-3.1904199" } ], "locationText" : "Edinburgh, City Of Edinburgh, United Kingdom", "employmentType" : "FULL_TIME", "experienceMinYears" : 10, "experienceLevel" : "Director", "professionalSkills" : [ "Client account management", "Business Development", "Relationship development", "Stakeholder management", "Influencing skills" ], "hardSkillsList" : [ "Risk management", "Compliance", "Regulatory change" ], "hardSkills" : [ { "name" : "Risk management", "level" : "intermediate" }, { "name" : "Compliance", "level" : "intermediate" }, { "name" : "Regulatory change", "level" : "intermediate" } ], "majorSkills" : "Regulatory, Compliance, Risk, Asset Management", "majorSkillsList" : [ "Regulatory", "Compliance", "Risk", "Asset Management" ], "coreResponsibilities" : "Lead client engagements, Manage Alpha team, Manage contractors, Develop strategies, Drive high-quality work, Deliver strategies, Analyze client current state, Develop proposals, Implement recommendations, Implement solutions, Conduct research, Conduct surveys, Conduct interviews, Discuss organisational problems, Monitor project progress, Manage project risks, Inform stakeholders about progress, Inform stakeholders about outcomes, Review current processes, Analyze client reports, Analyze client documentation, Research new methods, Research new procedures, Flag deviations from procedures, Stay abreast of business trends, Stay abreast of industry trends, Develop client relationships, Maintain client relationships, Contribute to business development, Undertake account management, Manage finances, Develop market propositions, Bring propositions to market", "teamCollaboration" : "Work with diverse stakeholders; Work in partnership", "projectManagementSkills" : [ "Project leadership", "Team leadership" ], "domainKnowledge" : "Asset and Wealth Management; Financial Services Regulation; Market Practice; FCA Regulation", "domainList" : [ "asset-and-wealth-management", "financial-services-regulation", "market-practice", "fca-regulation" ], "domainSpecificKnowledge" : [ "Asset and Wealth Management", "Financial Services Regulation", "Market Practice", "FCA Regulation" ], "communicationSkills" : "Presentation skills; Problem-solving skills", "specialRequirements" : "Willingness to travel", "outcomesObjectives" : "Achieve client satisfaction; Ensure client efficiency", "qualificationsBasic" : "10+ years consulting/in-house experience, Minimum 2:1 degree", "qualificationsPreferred" : "Experience in 'blue-chip' Financial Services, Experience in Asset or Wealth Managers, Industry recognised subject matter expert", "rawDescription" : "Alpha Financial Markets Consulting (Alpha FMC) is the leading global consultancy to the asset and wealth management industry. We are a boutique management consulting firm that offers the world’s top asset and wealth managers a competitive edge through our unrivalled expertise and industry insight. Our firm was founded in 2003 at its London headquarters, and its rapid expansion led to a successful IPO in October 2017. Our client base covers all of the world’s top 20 and 80% of the top 50 asset managers by AUM, and we have worked with over 870 clients globally. We are headquartered in the United Kingdom but have 17 offices globally including the United States, Canada, Luxembourg, France, Netherlands, Switzerland, Denmark, Germany, Singapore and Australia. Globally we employ over 990 full-time consultants which enables us to provide deep expertise to our extensive client base. To clients, we are a trusted partner for change programmes, however, we are so much more to our employees. At Alpha, we pride ourselves in being a meritocratic environment perfect for building a career, meeting great people, as well as a rewarding place to work. This is an exciting opportunity to join Alpha’s Regulatory Compliance & Risk practice and be part of shaping our continued growth, working in close collaboration with the team to delivering the work we undertake for our clients. Alpha’s leading Regulatory Compliance & Risk practice enables us to support our clients meet Regulators’ evolving expectations and the business standards our clients seek. Our deep understanding of Regulation, Risk and Market Practice enables us to work closely with our clients to manage regulatory change and enhance the way they operate. We have built a uniquely qualified team who bring an unrivalled knowledge to the Asset and Wealth sector. We know how the regulator ‘trains its people to think’ and what good practice looks like. We work directly with our clients C-suite to deliver the outcomes they seek – which means we are ‘hands-on in the business’. Please see below an outline of the responsibilities of the role as well as the requirements. Role Requirements (Skills, Experience and Qualifications): A minimum of 10 years proven consulting and/or in-house experience in Compliance, Regulation or Risk or with the FCA A recognise leader in Risk and Compliance topics for the Asset and Wealth Management sector Significant experience within ‘blue-chip’ Financial Services organisations, preferably Asset or Wealth Managers Experience of leading project and/or in-house teams on regulatory change, compliance and/or risk Demonstrable subject matter expertise in key regulatory and risk topics An in-depth understanding of market trends, drivers and outlook of the Asset and Wealth Management market, in particular in relation the impact of current and future regulation Demonstrable proficiency in relationship development and client account management A network of executive contacts across the industry and proven experience of Business Development Ability to show initiative when dealing with clients, form strong relationships with new clients, and maintain existing relationships. Senior stakeholder management and influencing skills, demonstrated with clients and colleagues First class communication, presentation and problem-solving skills Superb interpersonal skills, with ability to influence and lead The ability to mentor and coach other colleagues and lead project team Ability to develop new go to market propositions in the areas of Risk, Regulation and Compliance Proven track record delivering complex Risk and Compliance projects for the Asset and Wealth Managers Ability to convert propositions into pipeline into sales Industry recognised subject matter expert in at least one in demand area within Risk and Compliance Strong academic background including a minimum of a 2:1 degree from a leading institution Business language fluency in English and willingness to travel Role Responsibilities: Leading highly successful client engagements to achieve strong client satisfaction rating - including management of Alpha team and potentially contractors too Developing strategies and driving high-quality work products within expected timeframes on budget Delivering strategies by bringing together diverse stakeholders to work effectively in partnership Developing subject matter expertise and IP in relation to regulatory and risk themes and be recognised by clients and colleagues as an expert Analysing the client current state, developing proposals, and assisting and implementing recommendations or solutions to ensure the best use of clients’ resources Conducting research, surveys and interviews and discussing organisational problems with clients Monitoring progress, managing risks and ensuring key stakeholders are kept informed about progress of project and expected outcomes to ensure client efficiency Reviewing current processes, analysing client organisational reports and other documentation, researching new methods and procedures and flagging deviations from standard procedures Staying abreast of current business and industry trends relevant to the client's business Develop and maintain long-term client relationships and networks Making a strong contribution towards business development Undertaking effective account management including financial management Develop and bring to market leading propositions in key areas of demand", "summaryDescription" : "Director (Regulatory, Compliance & Risk) at Alpha Financial Markets Consulting. Skills: Regulatory, Compliance, Risk, Asset Management. Lead client engagements. Manage Alpha team", "postedDate" : "2026-06-14T18:46:51.687", "createdAt" : "2026-06-14T18:46:51.687", "lastUpdated" : "2026-06-16T02:01:01.497", "ingestTimestamp" : "2026-06-14T18:46:51.687", "mongoId" : "6a2ca57974d8ee00a09b6af6", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "100k-150k", "hasSalary" : false, "allSkills" : [ "Risk management", "Compliance", "Regulatory change", "Regulatory", "Risk", "Asset Management", "Client account management", "Business Development", "Relationship development", "Stakeholder management", "Influencing skills", "Project leadership", "Team leadership", "Asset and Wealth Management", "Financial Services Regulation", "Market Practice", "FCA Regulation" ], "skillCount" : 17, "jobCategory" : "general", "jobSubcategory" : "general", "seniorityLevel" : "Director", "dataQualityScore" : 1.0, "_score" : 850.4554, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Financial Services", "llmIndustryConfidence" : 0.98 }, { "id" : "69ce5d249bc74574cb661a75", "title" : "Maritime Regulatory Principal", "company" : "Zeno Power", "industry" : "Climate Tech", "salary" : { "min" : 215000.0, "max" : 315000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline data for a Lead Maritime Regulatory Principal in Washington, United States, adjusted for the technology industry and company size." }, "location" : "Washington, DC", "locations" : [ "Washington", "DC" ], "timestamp" : "2026-06-16T05:05:19.677", "fingerprint" : "cd0d628d0ef82c57b567f6aae5627f7d3b4f298f0bfd797af4212aabc650a783", "source" : "breezyhr", "language" : "en", "applyUrl" : "https://zeno-power.breezy.hr/p/346b7067ef92-maritime-regulatory-principal", "externalId" : "346b7067ef92", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Washington", "state" : "District of Columbia", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "38.8950982,-77.0363849" } ], "locationText" : "Washington, District of Columbia, United States", "employmentType" : "FULL_TIME", "remoteFriendly" : false, "rawDescription" : "Company Overview Zeno Power is the leading developer of nuclear batteries – compact power systems that provide reliable, clean energy in frontier environments. By harnessing the heat from radioisotopes, Zeno’s batteries power critical missions on Earth, in space, and at sea. To bring this technolog", "summaryDescription" : "Maritime Regulatory Principal at Zeno Power", "createdAt" : "2026-06-14T21:47:24.350", "lastUpdated" : "2026-06-16T05:05:19.677", "ingestTimestamp" : "2026-06-14T21:47:24.350", "mongoId" : "69ce5d249bc74574cb661a75", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 215000, "salaryAnnualMax" : 315000, "salaryBand" : "200k+", "hasSalary" : true, "allSkills" : [ ], "skillCount" : 0, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Lead", "dataQualityScore" : 0.6666667, "_score" : 843.0852, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Technology", "llmIndustryConfidence" : 0.92 }, { "id" : "6a2c5e6674d8ee00a08e3c22", "title" : "Associate Director, Regulatory Affairs Medical Writing", "company" : "Beeline Medicines", "industry" : "Biotechnology", "salary" : { "min" : 175000.0, "max" : 250000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline data for Biotech industry in the United States, adjusted for Director seniority and company size." }, "location" : "United States", "locations" : [ "United States" ], "timestamp" : "2026-06-15T00:40:22.706", "fingerprint" : "bcde5195628fbada21a4539433c8bff772bc1b2ea6d12316189f4dc4623646c3", "source" : "greenhouse", "language" : "en", "applyUrl" : "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. 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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, "_score" : 841.70996, "daysOld" : 1, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Healthcare" }, { "id" : "6a2af78274d8ee00a073d614", "title" : "Regulatory Affairs Manager", "company" : "AstraZeneca", "industry" : "Healthcare", "salary" : { "min" : 1000000.0, "max" : 1800000.0, "currency" : "EGP", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Manager in the Pharma industry in Egypt, adjusted for seniority and company size." }, "location" : "Egypt", "locations" : [ "Egypt" ], "timestamp" : "2026-06-14T22:43:26.705", "fingerprint" : "30bf7bd4001e469bf25bccf02bbe126ff8ef263b558f8ae5481c7401de5aed97", "source" : "workday", "language" : "en", "applyUrl" : "https://astrazeneca.wd3.myworkdayjobs.com/Careers/job/Egypt/Regulatory-Affairs-Manager_R-254239-1", "externalId" : "R-254239", "industryFunction" : { }, "locationPoint" : "26.8206,30.8025", "structuredLocations" : [ { "country" : "Egypt", "continent" : "af", "workMode" : "onsite" } ], "locationText" : "Egypt", "employmentType" : "FULL_TIME", "minimumEducation" : "Bachelor's", "experienceLevel" : "Manager", "professionalSkills" : [ "Regulatory strategy", "Lifecycle management", "Product registration", "Labeling", "Post-approval changes", "Regulatory dossiers", "Health authority interactions", "Agency communications", "Compliance", "Quality culture", "Change control", "Market continuity", "Product compliance", "Risk assessments", "Transparent decision-making", "Business planning" ], "hardSkillsList" : [ "Regulatory filing", "Dossier preparation", "Response writing", "Submission management", "Labeling development", "Change assessment" ], "hardSkills" : [ { "name" : "Regulatory filing", "level" : "intermediate" }, { "name" : "Dossier preparation", "level" : "intermediate" }, { "name" : "Response writing", "level" : "intermediate" }, { "name" : "Submission management", "level" : "intermediate" }, { "name" : "Labeling development", "level" : "intermediate" }, { "name" : "Change assessment", "level" : "intermediate" } ], "majorSkills" : "Regulatory strategy, Submission management, Health authority engagement, Compliance", "majorSkillsList" : [ "Regulatory strategy", "Submission management", "Health authority engagement", "Compliance" ], "coreResponsibilities" : "Develop regulatory strategies, Implement regulatory strategies, Lead dossier preparation, Coordinate dossier preparation, Review regulatory dossiers, Submit regulatory dossiers, Manage variations, Manage renewals, Respond to questions, Ensure activities align with regulations, Ensure activities align with company policies, Maintain inspection readiness, Partner with internal teams, Gather required documentation, Align regulatory plans, Resolve issues quickly, Contribute to labeling development, Review product labeling, Maintain product labeling, Assess regulatory impact, Define required submissions, Deliver required submissions, Build submission timelines, Maintain submission timelines, Build regulatory risk assessments, Maintain regulatory risk assessments, Enable transparent decision-making, Inform business planning", "teamCollaboration" : "Cross-functional collaboration; 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, "_score" : 841.20386, "daysOld" : 3, "hasLocation" : true, "hasGeo" : false, "llmIndustry" : "Healthcare" }, { "id" : "694ae6ce70f0b99d589b27fc", "title" : "Regulatory Complaints Associate", "company" : "Hyundai Capital America", "industry" : "Banking", "salary" : { "min" : 65000.0, "max" : 95000.0, "currency" : "USD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline data for a Mid-level Regulatory Complaints Associate in Irvine, United States, adjusted for the Financial Services industry and company size." }, "location" : "United States-California-Irvine", "locations" : [ "United States-California-Irvine", "
Headquarters 1 (HCA_HQ1)
3161 Michelson Dr. Ste 1900
Irvine, 92612

" ], "timestamp" : "2026-06-16T05:29:45.452", "fingerprint" : "3035ccd28190e3758a69a0e4fe5f0509d96ea47fc2283f34be3e5b2165b00cdf", "source" : "taleo", "language" : "en", "applyUrl" : "https://hyundaicapital.taleo.net/careersection/ex/jobdetail.ftl?job=105943", "externalId" : "105943", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Irvine", "state" : "California", "country" : "United States", "continent" : "na", "source" : "llm", "workMode" : "onsite", "geo" : "33.6856969,-117.8259810" } ], "locationText" : "Irvine, California, United States", "professionalSkills" : [ "Risk management", "Legal analysis", "Compliance oversight" ], "hardSkillsList" : [ "Regulatory requirements" ], "hardSkills" : [ { "name" : "Regulatory requirements", "level" : "intermediate" } ], "majorSkills" : "Regulatory requirements, Risk management, Legal analysis, Compliance oversight", "majorSkillsList" : [ "Regulatory requirements", "Risk management", "Legal analysis", "Compliance oversight" ], "coreResponsibilities" : "Oversee regulatory compliance, Manage legal risks, Analyze regulatory requirements, Ensure compliance oversight", "domainKnowledge" : "Regulatory compliance; Risk management; Legal analysis", "domainList" : [ "regulatory-compliance", "risk-management", "legal-analysis" ], "domainSpecificKnowledge" : [ "Regulatory compliance", "Risk management", "Legal analysis" ], "remoteFriendly" : false, "rawDescription" : "Who We Are Through our service brands Hyundai Motor Finance, Genesis Finance, and Kia Finance, Hyundai Capital America offers a wide range of financial products tailored to meet the needs of Hyundai, Genesis, and Kia customers and dealerships. We provide vehicle financing, leasing, subscription, and insurance solutions to over 2 million consumers and businesses. Embodying our commitment to grow, innovate, and diversify, we strive to reimagine the customer and dealer experience and launch innovative new products that broaden our market reach. We believe that success comes from within and are proud to support our team members through skill development and career advancement. Hyundai Capital America is an Equal Opportunity Employer committed to creating a diverse and inclusive culture for our workforce. We are a values-driven company dedicated to supporting both internal and external communities through volunteering, philanthropy, and the empowerment of our Employee Resource Groups. Together, we strive to be the leader in financing freedom of movement. We Take Care of Our People Along with competitive pay, as an employee of HCA, you are eligible for the following benefits: ·          Medical, Dental and Vision plans that include no-cost and low-cost plan options ·          Immediate 401(k) matching and vesting ·          Vehicle purchase and lease discounts plus monthly vehicle allowances ·          Paid Volunteer Time Off with company donation to a charity of your choice ·          Tuition reimbursement What to Expect The Regulatory Complaints Associate is responsible on a daily basis for drafting comprehensive responses to customer complaints submitted through HCA’s regulators in accordance with the applicable statutory timeline. What You Will Do 1.      Regulatory Complaint Daily Activity ·          Draft and review other responses to complaints received through the Consumer Financial Protection Bureau (CFPB) and state regulators, including working with HCA’s CARE Team to obtain research, validation of research, preparation, and submission of responses. ·          Monitor the State Examination System complaint portal on a daily basis to obtain and respond accurately, thoroughly and timely to regulator complaints. ·          Identify potential regulatory risks while responding to complaints ·          Formulate recommendations and escalate internally, as needed. ·          Serve as a point of contact for state regulators regarding complaints, working directly with state regulators to respond to complaints and resolve escalated regulatory complaint issues. ·          Document accounts and include all relevant information and documents. 2.      Complaint Analysis and Review ·          Assist in analyzing regulatory complaint data, including completing reviews of internal complaints identified as potentially being regulatory in nature, and preparing recaps of regulatory complaints where the driver is HCA Error. ·          Complete high risk complaint category reviews and provide feedback to the business on any issues or opportunities identified. Develop remediation and training plans to be presented to management for implementation by the business to reduce complaint volume. 3.      Reporting ·          Assist in analyzing regulatory complaint data ·          Assist in preparing and distributing monthly, quarterly and ad-hoc report summaries related to regulator complaints. What You Will Bring ·          Minimum 2-4 years related experience in escalated customer complaints. ·          Experience in the auto finance industry a plus. ·          Bachelor’s degree or equivalent work experience required. ·          Strong problem solving and analytical skills to successfully address regulator complaints, perform root cause analysis and identify trends. ·          Excellent communication skills, written and verbal, with the ability to effectively communicate with all levels in the organization and external state regulator personnel. ·          Strong attention to detail. ·          Knowledge of applicable federal regulations and general compliance concepts. ·          Proficient with Microsoft Office (Word, Excel, PowerPoint) ·          Demonstrated ability to learn systems and processes. Work Environment Employees in this class are subject to extended periods of sitting, standing and walking, and using a computer. Work is performed in an office environment. The posted salary range for this job takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; geographic location, and other business and organizational needs. Successful candidates may be hired anywhere in the salary range based on these factors. It is uncommon to hire candidates at or near the top of the range. California Privacy Notice This notice only applies to our applicants who reside in the State of California. The latest version of our Privacy Policy can be found here . This Privacy Policy provides you with notice, at or before the point of collection, about the categories of personal information to be collected from you, the purposes for which your personal information is collected or used, and whether that information is sold or shared, so that you can exercise meaningful control over our use of your personal information. We are providing this notice to comply with the California Consumer Privacy Act of 2018, as amended as amended by the California Privacy Rights Act of 2020 (“CCPA”). If you have any questions about CCPA regarding California residents or HCA team members, please contact the Privacy Team at Privacy2@hcs.com . United States-California-Irvine", "summaryDescription" : "Regulatory Complaints Associate at Hyundai Capital America. Skills: Regulatory requirements, Risk management, Legal analysis, Compliance oversight. Oversee regulatory compliance. Manage legal risks", "createdAt" : "2026-06-14T18:52:14.313", "lastUpdated" : "2026-06-16T05:29:45.452", "ingestTimestamp" : "2026-06-14T18:52:14.313", "mongoId" : "694ae6ce70f0b99d589b27fc", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryAnnualMin" : 65000, "salaryAnnualMax" : 95000, "salaryBand" : "50k-75k", "hasSalary" : true, "allSkills" : [ "Regulatory requirements", "Risk management", "Legal analysis", "Compliance oversight", "Regulatory compliance" ], "skillCount" : 5, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Mid", "dataQualityScore" : 0.6666667, "_score" : 838.5749, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Financial Services", "llmIndustryConfidence" : 0.95 }, { "id" : "6a30565df292fd229cf28d37", "title" : "Legal Counsel (Regulatory & Licensing)", "company" : "BTSE Group", "industry" : "Legal", "salary" : { "min" : 600000.0, "max" : 900000.0, "currency" : "HKD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Junior Legal Counsel in Hong Kong's FinTech industry, adjusted for mid-level experience and full-time employment." }, "location" : "Hong Kong", "locations" : [ "Hong Kong", "Southeast Asia" ], "timestamp" : "2026-06-16T11:56:24.511", "fingerprint" : "56ba633be0d8f0eb8f990b3cd8e70b22933c90257f9d88fd7a2ba31e6a51246c", "source" : "lever", "language" : "en", "applyUrl" : "https://jobs.lever.co/BTSE/242e4684-8cf7-45c7-9349-a8274de341f8/apply", "externalId" : "242e4684-8cf7-45c7-9349-a8274de341f8", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Hong Kong", "country" : "Hong Kong", "continent" : "as", "source" : "llm", "workMode" : "onsite", "geo" : "22.2818333,114.1582831" } ], "locationText" : "Hong Kong, Hong Kong", "employmentType" : "FULL_TIME", "experienceMinYears" : 3, "experienceMaxYears" : 5, "experienceLevel" : "Mid", "professionalSkills" : [ "Risk management", "Legal analysis", "Compliance oversight" ], "hardSkillsList" : [ "Regulatory analysis", "License applications" ], "softSkillsList" : [ "Leadership" ], "hardSkills" : [ { "name" : "Regulatory analysis", "level" : "intermediate" }, { "name" : "License applications", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Leadership" } ], "majorSkills" : "Regulatory compliance, Licensing, Risk management", "majorSkillsList" : [ "Regulatory compliance", "Licensing", "Risk management" ], "coreResponsibilities" : "Lead license applications, Project-manage license applications, Monitor global crypto regulations, Analyze global crypto regulations, Brief executive team on regulations, Partner with Compliance team, Translate regulatory requirements, Develop operational policies, Develop audit-ready workflows", "teamCollaboration" : "Work as part of a team; Partner closely with Compliance", "projectManagementSkills" : [ "Project management" ], "domainKnowledge" : "VASP; MiCA; MSB; Crypto regulations; Fintech structures; Payment service laws", "domainList" : [ "vasp", "mica", "msb", "crypto-regulations", "fintech-structures", "payment-service-laws" ], "domainSpecificKnowledge" : [ "VASP", "MiCA", "MSB", "Crypto regulations", "Fintech structures", "Payment service laws" ], "communicationSkills" : "English communication; Chinese communication", "qualificationsBasic" : "Qualified lawyer, 3+ years financial regulation experience, Deep knowledge of crypto regulatory frameworks, Deep knowledge of traditional fintech structures, Deep knowledge of payment service laws, Exceptional relationship-building skills, Meticulous attention to detail, Proactive approach to risk management, Hands on at work, Independent in managing complex projects, Great communication skills in English, Great communication skills in Chinese, Familiar with crypto use cases", "qualificationsPreferred" : "Experience with VASP licenses, Experience with MiCA licenses, Experience with MSB licenses", "remoteFriendly" : true, "workSiteFlexibility" : "Remote", "rawDescription" : "## Description About BTSE: 彼特思方舟 is a specialized service provider dedicated to delivering a full spectrum of front-office and back-office support solutions, each of which are tailored to the unique needs of global financial technology firms. 彼特思方舟 is engaged by BTSE Group to offer several key positions, enabling the delivery of cutting-edge technology and tailored solutions that meet the evolving demands of the fintech industry in a competitive global market. BTSE Group is a leading global fintech and blockchain company that is committed to building innovative technology and infrastructure. BTSE empowers businesses and corporate clients with the advanced tools they need to excel in a rapidly evolving and competitive market. BTSE has pioneered numerous trading technologies that have been widely adopted across the industry, setting new benchmarks for innovation, performance, and security in fintech. BTSE’s diverse business lines serve both retail (B2C) customers and institutional (B2B) clients, enabling them to launch, operate, and scale fintech businesses. BTSE is seeking ambitious, motivated professionals to join our B2C and B2B teams. About the Opportunity: Navigating the global regulatory patchwork is our biggest challenge and opportunity. This role is dedicated to securing our global footprint by leading license applications and building an ironclad bridge between Legal and our Compliance/AML teams. ## Responsibilities Lead and project-manage applications for VASP, MiCA, MSB, and other regional financial licenses globally. Monitor, analyze, and brief the executive team on shifting global crypto regulations (e.g., SEC, CFTC, FCA, MAS developments). Partner closely with the Compliance team to translate regulatory requirements into concrete operational policies and audit-ready workflows. ## Requirement Qualified lawyer. Experience: At least 3 years of experience specializing in financial regulation. Deep knowledge of crypto regulatory frameworks, traditional fintech structures, or payment service laws. Exceptional relationship-building skills for interacting with regulators, meticulous attention to detail, and a proactive approach to risk management. Hands on at work and can be independent in managing complex projects whilst still working as part of a team. Great communication skills in both English and Chinese. Familiar with crypto use cases. ## Perks & Benefits Competitive total compensation package Various team-building programs and company events And many more! Apply and let us tell you more! ## Additional Information #LI-JY1", "summaryDescription" : "Legal Counsel (Regulatory & Licensing) at BTSE Group. Skills: Regulatory compliance, Licensing, Risk management. Lead license applications. 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BTSE Group is a leading global fintech and blockchain company that is committed to building innovative technology and infrastructure. BTSE empowers businesses and corporate clients with the advanced tools they need to excel in a rapidly evolving and competitive market. BTSE has pioneered numerous trading technologies that have been widely adopted across the industry, setting new benchmarks for innovation, performance, and security in fintech. BTSE’s diverse business lines serve both retail (B2C) customers and institutional (B2B) clients, enabling them to launch, operate, and scale fintech businesses. BTSE is seeking ambitious, motivated professionals to join our B2C and B2B teams. About the Opportunity: Navigating the global regulatory patchwork is our biggest challenge and opportunity. This role is dedicated to securing our global footprint by leading license applications and building an ironclad bridge between Legal and our Compliance/AML teams. ## Responsibilities Lead and project-manage applications for VASP, MiCA, MSB, and other regional financial licenses globally. Monitor, analyze, and brief the executive team on shifting global crypto regulations (e.g., SEC, CFTC, FCA, MAS developments). Partner closely with the Compliance team to translate regulatory requirements into concrete operational policies and audit-ready workflows. ## Requirement Qualified lawyer. Experience: At least 3 years of experience specializing in financial regulation. Deep knowledge of crypto regulatory frameworks, traditional fintech structures, or payment service laws. Exceptional relationship-building skills for interacting with regulators, meticulous attention to detail, and a proactive approach to risk management. Hands on at work and can be independent in managing complex projects whilst still working as part of a team. Great communication skills in both English and Chinese. Familiar with crypto use cases. ## Perks & Benefits Competitive total compensation package Various team-building programs and company events Comprehensive healthcare schemes for employees and dependants And many more! Apply and let us tell you more! ## Additional Information #LI-JY1", "summaryDescription" : "Legal Counsel (Regulatory & Licensing) at BTSE Group. Skills: Regulatory compliance, Licensing, Risk management. Lead license applications. Project-manage license applications", "postedDate" : "2026-06-15T04:28:09.345", "createdAt" : "2026-06-15T04:28:09.345", "lastUpdated" : "2026-06-16T10:13:07.088", "ingestTimestamp" : "2026-06-16T03:21:43.026", "mongoId" : "6a30565df292fd229cf28d38", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "200k+", "hasSalary" : false, "allSkills" : [ "Regulatory analysis", "License applications", "Regulatory compliance", "Licensing", "Risk management", "Project management", "Complex project management", "Crypto regulatory frameworks", "Fintech structures", "Payment service laws", "VASP regulations", "MiCA regulations", "MSB regulations" ], "skillCount" : 13, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Mid", "dataQualityScore" : 1.0, "_score" : 835.8475, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "FinTech", "llmIndustryConfidence" : 0.98 }, { "id" : "6a2c96fc74d8ee00a099116d", "title" : "Regulatory Legal Counsel", "company" : "IMC", "industry" : "Legal", "salary" : { "min" : 2500000.0, "max" : 4500000.0, "currency" : "INR", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market data for a Mid-level Regulatory Legal Counsel in the FinTech industry in Mumbai, India, adjusted for seniority and company size." }, "location" : "Mumbai, India", "locations" : [ "Mumbai", "India" ], "timestamp" : "2026-06-15T09:32:20.990", "fingerprint" : "3dcbab8b9bd0605fd7c053c585efe0d71c1c4643716c4ca38f00e2676672edb3", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.eu.greenhouse.io/imc/jobs/4896109101", "externalId" : "4896109101", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Mumbai", "country" : "India", "continent" : "as", "source" : "llm", "workMode" : "onsite", "geo" : "19.0549990,72.8692035" } ], "locationText" : "Mumbai, India", "minimumEducation" : "Bachelor's", "experienceMinYears" : 5, "experienceMaxYears" : 8, "experienceLevel" : "Mid", "professionalSkills" : [ "Legal analysis", "Risk management", "Commercial strategy" ], "hardSkillsList" : [ "Regulatory law", "Indian regulations", "Commercial contracts", "Transactional work", "Corporate governance", "Intellectual property", "Employment law" ], "softSkillsList" : [ "Cross-functional mindset", "Pragmatic approach" ], "hardSkills" : [ { "name" : "Regulatory law", "level" : "intermediate" }, { "name" : "Indian regulations", "level" : "intermediate" }, { "name" : "Commercial contracts", "level" : "intermediate" }, { "name" : "Transactional work", "level" : "intermediate" }, { "name" : "Corporate governance", "level" : "intermediate" }, { "name" : "Intellectual property", "level" : "intermediate" }, { "name" : "Employment law", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Cross-functional mindset" }, { "name" : "Pragmatic approach" } ], "majorSkills" : "Regulatory law, Indian financial regulations, Legal advice", "majorSkillsList" : [ "Regulatory law", "Indian financial regulations", "Legal advice" ], "coreResponsibilities" : "Provide legal advice, Monitor regulatory developments, Interpret regulatory developments, Advise on compliance, Collaborate with compliance teams, Collaborate with risk management teams, Assist in resolution, Support general legal matters, Align legal advice, Understand new functional areas, Apply legal concepts, Problem-solve pragmatically", "teamCollaboration" : "Collaborate across departments; Cross-functional mindset", "domainKnowledge" : "Indian regulations; Derivatives markets; Commodities markets; Proprietary trading; SEBI Circulars; Stock-Brokers Regulations, 1992; NSE Bye-laws and Rules; BSE Bye-laws and Rules; MCX Bye-laws and Rules", "domainList" : [ "indian-regulations", "derivatives-markets", "commodities-markets", "proprietary-trading", "sebi-circulars", "stock-brokers-regulations", "1992", "nse-bye-laws-and-rules", "bse-bye-laws-and-rules", "mcx-bye-laws-and-rules" ], "domainSpecificKnowledge" : [ "Indian regulations", "Derivatives markets", "Commodities markets", "Proprietary trading", "SEBI Circulars", "Stock-Brokers Regulations, 1992", "NSE Bye-laws and Rules", "BSE Bye-laws and Rules", "MCX Bye-laws and Rules" ], "communicationSkills" : "Written communication; Verbal communication", "problemSolvingSkills" : "Problem-solving; Apply legal concepts", "qualificationsBasic" : "5 to 8 years of legal experience, Focus on regulatory matters, Financial services industry experience, In-depth knowledge of Indian financial regulations", "qualificationsPreferred" : "Experience in derivatives, Experience in commodities, Experience in proprietary trading, Experience in commercial and transactional work, Familiarity with automated trading strategies, Familiarity with algorithmic trading strategies, Master’s degree in Financial or Corporate Law, Experience in corporate governance, Experience in commercial contracts, Experience in IP, Experience in employment law", "remoteFriendly" : false, "workSiteFlexibility" : "Onsite", "rawDescription" : "We are seeking an experienced Regulatory Legal Counsel to join our legal team. The ideal candidate will have 5 to 8 years of experience in regulatory law, particularly in the financial services industry, with a focus on derivatives, commodities and/or proprietary trading. This position requires a deep understanding of applicable Indian regulations and a proven ability to see the bigger picture and align legal strategies with commercial objectives. In addition to regulatory matters, the role will also involve supporting a range of non-regulatory and commercial matters. Therefore, experience in commercial and transactional work is highly desirable. The candidate must be nimble in applying legal concepts to solve problems, especially with respect to novel issues, and have a cross-functional mindset to understand new functional areas quickly. A detail-oriented, hands-on approach to both legal and business challenges is essential. Your Core Responsibilities Provide legal advice on Indian regulatory matters impacting proprietary trading, including but not limited to SEBI Circulars, Securities Contracts (Regulation) Act, 1956, Securities Contracts (Regulation) Rules, 1957, Stock-Brokers Regulations, 1992, NSE, BSE, MCX - Bye-laws and Rules. Monitor, interpret, and advise on new regulatory developments, ensuring the firm’s compliance with applicable laws and regulations. Advise the firm on compliance with regulations pertaining to derivatives and commodities markets. Collaborate with the compliance and risk management teams to identify and mitigate regulatory risks. Assist in the resolution of regulatory and compliance issues arising from audits, investigations, or enforcement actions. Demonstrate a willingness to support other general in-house legal matters, such as corporate governance, commercial contract negotiation, intellectual property, and employment law, as needed. Proven ability to see the bigger picture and align legal advice with the firm’s commercial strategy Quickly understand new functional areas and collaborate across departments with a cross-functional mindset. Apply legal concepts to problem-solve in a nimble, pragmatic manner, especially when dealing with novel or complex issues. Detail-oriented, commercial, and hands-on approach to both legal and business issues. Your Skills and Experience 5 to 8 years of legal experience with a focus on regulatory matters in the financial services industry, ideally with exposure to proprietary trading, derivatives, and/or commodities. Prior experience working at a proprietary trading firm, broker-dealer, or financial institution is preferred. Familiarity with automated or algorithmic trading strategies is preferred. Bachelor’s (LL.B) or (preferred) Master’s (LL.M) degree in Financial or Corporate Law from a recognized and accredited law school In-depth knowledge of Indian financial regulations. Experience in other in-house legal areas, such as corporate governance, commercial contracts, IP, employment law is recommended. Strong analytical, problem-solving, and communication skills. Excellent written and verbal communications skills in English. Ability to work independently and collaboratively in a fast-paced environment. High attention to detail and strong organizational skills. About Us IMC is a global trading firm powered by a cutting-edge research environment and a world-class technology backbone. Since 1989, we’ve been a stabilizing force in financial markets, providing essential liquidity upon which market participants depend. Across our offices in the US, Europe, Asia Pacific, and India, our talented quant researchers, engineers, traders, and business operations professionals are united by our uniquely collaborative, high-performance culture, and our commitment to giving back. From entering dynamic new markets to embracing disruptive technologies, and from developing an innovative research environment to diversifying our trading strategies, we dare to continuously innovate and collaborate to succeed.", "summaryDescription" : "Regulatory Legal Counsel at IMC. Skills: Regulatory law, Indian financial regulations, Legal advice. Provide legal advice. 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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. Foster a diverse workplace", "postedDate" : "2026-06-11T14:37:09.920", "createdAt" : "2026-06-11T14:37:09.847", "lastUpdated" : "2026-06-12T21:34:36.469", "ingestTimestamp" : "2026-06-11T14:37:09.847", "mongoId" : "6a2a612774d8ee00a0621394", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "sourceUrl" : "https://abbott.wd5.myworkdayjobs.com/abbottcareers/job/United-States--Alameda--2601-Harbor-Bay-Parkway/Senior-Manager--Regulatory-Affairs---Lingo--on-site-_31151541-2", "salaryAnnualMin" : 130700, "salaryAnnualMax" : 261300, "salaryBand" : "100k-150k", "hasSalary" : true, "allSkills" : [ "Regulatory submissions", "Data presentation", "Labeling review", "Advertising review", "Promotional review", "Leadership", "Change leadership", "Regulatory Affairs", "Product registration", "Compliance", "Regulatory strategy", "Compliance oversight", "Risk management", "Legal analysis", "Program management", "Medical device software regulations", "EU MDR", "QSR", "ISO standards", "EN standards", "RAC" ], "skillCount" : 21, "jobCategory" : "engineering", "seniorityLevel" : "manager", "dataQualityScore" : 1.0, "_score" : 827.23584, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "Healthcare" }, { "id" : "6a305ad0f292fd229cf55ea3", "title" : "Director, Financial Operations & Regulatory Reporting", "company" : "Tipalti", "industry" : "SaaS", "salary" : { "min" : 170000.0, "max" : 233000.0, "currency" : "CAD", "frequency" : "yearly", "is_estimated" : false }, "location" : "Toronto, Ontario, Canada", "locations" : [ "Toronto", "Ontario", "Canada", "Vancouver", "British Columbia", "Canada" ], "timestamp" : "2026-06-16T08:11:04.892", "fingerprint" : "fe3612c6d42bd75e270bebe8a274704ed53e9b3f86461c1eacae79067ad7bea1", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://tipalti.com/jobs/?gh_jid=6019684004", "externalId" : "6019684004", "industryFunction" : { }, "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" : "Director", "technicalSkills" : "US GAAP, SBC", "professionalSkills" : [ "Financial operations", "Regulatory reporting", "Data analysis" ], "hardSkillsList" : [ "Equity accounting", "Regulatory frameworks" ], "softSkillsList" : [ "Adaptability" ], "hardSkills" : [ { "name" : "Equity accounting", "level" : "intermediate" }, { "name" : "Regulatory frameworks", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Adaptability" } ], "majorSkills" : "Financial Operations, Regulatory Reporting, Data Analysis", "majorSkillsList" : [ "Financial Operations", "Regulatory Reporting", "Data Analysis" ], "coreResponsibilities" : "Solve complex business problems, Translate complex financial concepts", "teamCollaboration" : "Non-finance stakeholders; Legal; Compliance; Sales; People Ops", "domainKnowledge" : "US GAAP; Equity accounting; Multi-entity regulatory frameworks", "domainList" : [ "us-gaap", "equity-accounting", "multi-entity-regulatory-frameworks" ], "domainSpecificKnowledge" : [ "US GAAP", "Equity accounting", "Multi-entity regulatory frameworks" ], "toolProficiency" : [ "Shareworks", "PowerBI", "Tableau", "Alteryx", "Claude", "Gemini" ], "communicationSkills" : "Verbal communication; Written communication", "problemSolvingSkills" : "Analytical skills", "qualificationsBasic" : "US GAAP knowledge, Equity accounting knowledge, Multi-entity regulatory frameworks knowledge", "qualificationsPreferred" : "Equity management platforms experience, Data visualization tools experience, AI tools experience", "remoteFriendly" : false, "rawDescription" : "Position Overview We are seeking a highly analytical, strategic, and hands-on Director, Financial Operations comfort working with massive, high-volume datasets to solve complex business problems. Systems Knowledge: Experience with equity management platforms (e.g., Shareworks) and data visualization and AI tools (e.g., PowerBI, Tableau, Alteryx, Claude, Gemini, etc.) is a major plus. Technical Accounting: Strong foundational knowledge of US GAAP, equity accounting (SBC), and multi-entity regulatory frameworks. Communication: Excellent verbal and written communication skills, with the ability to translate complex financial concepts to non-finance stakeholders (Legal, Compliance, Sales, People Ops). Adaptability: Ability to thrive and remain agile in a fast-paced, rapidly scaling corporate environment. Attention to Detail: Intense focus on accuracy, compliance, and meticulous organizational design. The anticipated base pay rate for this position is 170,000 - 233,000 USD annually. Expected Total Compensation: 170,000 - 233,000 USD annually. The compensation information, above, reflects our reasonable expectation for this role based on several factors, including current market conditions. Final compensation will be determined through individual assessment of experience, skills, qualifications, and other job-relevant factors. Actual offers may vary within or, only in exceptional circumstances, outside the stated range based on the candidate's unique qualifications and our comprehensive evaluation process. We are committed to equitable compensation practices in compliance with applicable employment laws. Our Mission Our mission is to elevate how finance teams operate in the global economy. We empower our customers to scale faster and smarter by removing the complexities of doing global business and accelerating their finance operations efficiency. We are the AI-powered platform that automates finance. Tipalti is fueled by a commitment to our customers and a desire to build lasting connections. Our client portfolio includes high-velocity businesses such as Amazon Twitch, GoDaddy, Roku, WordPress.com, and ZipRecruiter. We work hard for our 99% customer retention rate which is built on trust, reliability and innovation. Tipalti means we handled it\" - a mission to which we are constantly committed. Accommodations Tipalti champions inclusive teams, in which every voice counts. We are committed to recruiting diverse candidates with varied personal experiences and abilities. We welcome applications from candidates belonging to historically underrepresented or disadvantaged groups, and maintain an equitable Talent Acquisition process that is free from discrimination. As an equal opportunities employer, Tipalti complies with employment and human rights laws across the various jurisdictions in which we operate. Should you require reasonable adjustments or accommodations during the recruitment process, including access to alternate formats of materials, meeting spaces, or other accommodations that could better enable your full participation, please reach out to hr@tipalti.com for assistance. AI Use We may use artificial intelligence and automated systems (collectively \"AI\") to screen, assess, and select candidates during our recruitment process. This includes resume screening, skills assessment, and candidate matching. You have the right to request human review of any automated decision. For more information about how we collect and use personal data and information during recruitment, please refer to our Job Candidate Privacy Notice. For additional questions about our use of AI during our recruitment process, you can contact hr@tipalti.com. Privacy We are committed to protecting the privacy interests of job applicants and candidates. 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Systems Knowledge: Experience with equity management platforms (e.g., Shareworks) and data visualization and AI tools (e.g., PowerBI, Tableau, Alteryx, Claude, Gemini, etc.) is a major plus. Technical Accounting: Strong foundational knowledge of US GAAP, equity accounting (SBC), and multi-entity regulatory frameworks. Communication: Excellent verbal and written communication skills, with the ability to translate complex financial concepts to non-finance stakeholders (Legal, Compliance, Sales, People Ops). Adaptability: Ability to thrive and remain agile in a fast-paced, rapidly scaling corporate environment. Attention to Detail: Intense focus on accuracy, compliance, and meticulous organizational design. The anticipated base pay rate for this position is 165,000 - 195,000 CAD annually. Expected Total Compensation: 165,000 - 195,000 CAD annually. The compensation information, above, reflects our reasonable expectation for this role based on several factors, including current market conditions. Final compensation will be determined through individual assessment of experience, skills, qualifications, and other job-relevant factors. Actual offers may vary within or, only in exceptional circumstances, outside the stated range based on the candidate's unique qualifications and our comprehensive evaluation process. We are committed to equitable compensation practices in compliance with applicable employment laws. Our Mission Our mission is to elevate how finance teams operate in the global economy. We empower our customers to scale faster and smarter by removing the complexities of doing global business and accelerating their finance operations efficiency. We are the AI-powered platform that automates finance. Tipalti is fueled by a commitment to our customers and a desire to build lasting connections. Our client portfolio includes high-velocity businesses such as Amazon Twitch, GoDaddy, Roku, WordPress.com, and ZipRecruiter. We work hard for our 99% customer retention rate which is built on trust, reliability and innovation. Tipalti means we handled it\" - a mission to which we are constantly committed. Accommodations Tipalti champions inclusive teams, in which every voice counts. We are committed to recruiting diverse candidates with varied personal experiences and abilities. We welcome applications from candidates belonging to historically underrepresented or disadvantaged groups, and maintain an equitable Talent Acquisition process that is free from discrimination. As an equal opportunities employer, Tipalti complies with employment and human rights laws across the various jurisdictions in which we operate. Should you require reasonable adjustments or accommodations during the recruitment process, including access to alternate formats of materials, meeting spaces, or other accommodations that could better enable your full participation, please reach out to hr@tipalti.com for assistance. AI Use We may use artificial intelligence and automated systems (collectively \"AI\") to screen, assess, and select candidates during our recruitment process. This includes resume screening, skills assessment, and candidate matching. You have the right to request human review of any automated decision. For more information about how we collect and use personal data and information during recruitment, please refer to our Job Candidate Privacy Notice. For additional questions about our use of AI during our recruitment process, you can contact hr@tipalti.com. Privacy We are committed to protecting the privacy interests of job applicants and candidates. For more information about our privacy practices during our Talent Acquisition process, please refer to our Job Candidate Privacy Notice below: Job Candidate Privacy Notice | Tipalti www.tipalti.com/privacy/job-candidate-privacy-notice/", "summaryDescription" : "Director, Financial Operations & Regulatory Reporting at Tipalti. Skills: Financial Operations, Regulatory Reporting, Data Analysis. Solve complex business problems. Translate complex financial concepts", "postedDate" : "2026-06-15T23:24:36.530", "createdAt" : "2026-06-15T23:24:36.530", "lastUpdated" : "2026-06-16T08:00:06.789", "ingestTimestamp" : "2026-06-15T23:24:36.530", "mongoId" : "6a305ad0f292fd229cf55ea2", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "150k-200k", "hasSalary" : false, "allSkills" : [ "Financial reporting", "Regulatory compliance", "Data analysis", "Adaptability", "Agile", "Financial Operations", "Regulatory Reporting", "Data Analysis", "Financial operations", "Regulatory reporting", "US GAAP", "Equity accounting", "Multi-entity regulatory frameworks", "Shareworks", "PowerBI", "Tableau", "Alteryx", "Claude", "Gemini" ], "skillCount" : 19, "jobCategory" : "finance", "jobSubcategory" : "accounting", "seniorityLevel" : "Director", "dataQualityScore" : 1.0, "_score" : 826.6808, "daysOld" : 0, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "FinTech", "llmIndustryConfidence" : 0.95 }, { "id" : "6a2c916274d8ee00a0982aab", "title" : "Compliance Expert (Regulatory)", "company" : "Mangopay", "industry" : "FinTech", "salary" : { "min" : 65000.0, "max" : 95000.0, "currency" : "EUR", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Senior Compliance Expert in FinTech in Madrid, Spain, adjusted for seniority and company size." }, "location" : "Mangopay", "locations" : [ "Mangopay" ], "timestamp" : "2026-06-15T11:36:01.964", "fingerprint" : "7dae3a82941bbf5aa4c5b43c87748ab31a89abfd295cfd516198c25909e5f70e", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.eu.greenhouse.io/mangopay/jobs/4811489101", "externalId" : "4811489101", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Madrid", "country" : "Spain", "continent" : "eu", "source" : "llm", "workMode" : "onsite", "geo" : "40.4167820,-3.7035070" }, { "city" : "Paris", "country" : "France", "continent" : "eu", "source" : "llm", "workMode" : "onsite", "geo" : "48.8588897,2.3200410" }, { "city" : "Warsaw", "country" : "Poland", "continent" : "eu", "source" : "llm", "workMode" : "onsite", "geo" : "52.2333742,21.0711489" }, { "city" : "Berlin", "country" : "Germany", "continent" : "eu", "source" : "llm", "workMode" : "onsite", "geo" : "52.5173885,13.3951309" }, { "city" : "Luxembourg", "country" : "Luxembourg", "continent" : "eu", "source" : "llm", "workMode" : "onsite", "geo" : "49.6112768,6.1297990" }, { "city" : "London", "country" : "United Kingdom", "continent" : "eu", "source" : "llm", "workMode" : "onsite", "geo" : "51.5074456,-0.1277653" } ], "locationText" : "Madrid, Spain; Paris, France; Warsaw, Poland; Berlin, Germany; Luxembourg, Luxembourg; London, United Kingdom", "employmentType" : "FULL_TIME", "minimumEducation" : "Bachelor's", "experienceMinYears" : 5, "experienceMaxYears" : 10, "experienceLevel" : "Senior", "professionalSkills" : [ "Risk management", "Legal analysis", "Compliance oversight" ], "hardSkillsList" : [ "Regulatory requirements", "AML/CTF obligations", "KYC Reliance", "Whistleblowing", "Conflict of interest", "Anti-bribery", "Corruption" ], "hardSkills" : [ { "name" : "Regulatory requirements", "level" : "intermediate" }, { "name" : "AML/CTF obligations", "level" : "intermediate" }, { "name" : "KYC Reliance", "level" : "intermediate" }, { "name" : "Whistleblowing", "level" : "intermediate" }, { "name" : "Conflict of interest", "level" : "intermediate" }, { "name" : "Anti-bribery", "level" : "intermediate" }, { "name" : "Corruption", "level" : "intermediate" } ], "majorSkills" : "Regulatory compliance, AML/CTF, Risk assessment", "majorSkillsList" : [ "Regulatory compliance", "AML/CTF", "Risk assessment" ], "coreResponsibilities" : "Establish internal controls, Maintain internal controls, Conduct regular reviews, Conduct regular assessments, Prepare AML/CTF reports, Submit AML/CTF reports, Develop global policy, Maintain global policy, Act as SME, Defend Reliance model, Prove efficacy testing protocols, Develop policies, Update policies, Develop procedures, Update procedures, Design training plan, Implement training plan, Collaborate with stakeholders, Disseminate compliance policies, Disseminate compliance procedures, Act as primary contact, Coordinate audit activities, Respond to inquiries, Address findings, Address recommendations, Monitor regulatory changes, Assess impact, Implement necessary updates, Conduct periodic risk assessments, Identify compliance gaps, Develop mitigation strategies, Stay informed industry trends, Stay informed best practices, Stay informed emerging requirements, Provide recommendations process improvements, Provide recommendations enhancements", "teamCollaboration" : "Work collaboratively across departments; Internal stakeholders", "domainKnowledge" : "Banking regulation; Payments regulation; EMI regulation; Acquiring institutions; Financial services regulation; AML/CTF regulations; Industry best practices", "domainList" : [ "banking-regulation", "payments-regulation", "emi-regulation", "acquiring-institutions", "financial-services-regulation", "aml-ctf-regulations", "industry-best-practices" ], "domainSpecificKnowledge" : [ "Banking regulation", "Payments regulation", "EMI regulation", "Acquiring institutions", "Financial services regulation", "AML/CTF regulations", "Industry best practices" ], "communicationSkills" : "Written communication; Verbal communication", "documentationSkills" : "Maintain policies; Maintain procedures; Maintain compliance reports", "problemSolvingSkills" : "Analytical skills; Problem-solving skills", "qualificationsBasic" : "Bachelor's degree in Business, Law, Finance, Minimum 5 years Compliance experience, Proven track record regulatory compliance, Solid expertise AML/CTF regulations, Grasp internal control frameworks, Demonstrated ability draft policies, Excellent analytical skills, Excellent problem-solving skills, High attention to detail, Excellent written communication English, Excellent verbal communication English, Excellent written communication French, Excellent verbal communication French", "qualificationsPreferred" : "Knowledge of Salesforce, Knowledge of compliance tools, Knowledge of financial crime tools, Knowledge of fraud tools, Knowledge of AML tools, Knowledge of analytics solutions, Leadership responsibilities, Coordination responsibilities", "rawDescription" : "Mangopay is a wallet-based payment infrastructure built specifically for organisations with complex, multi-party fund flows. A pioneer in multi-party payments. Our solution optimises fund flows on behalf of the organisations we work with using wallets as programmable, composable building blocks. Mangopay’s regulated platform collects payments, secures transactions and holds funds, splits money between the various parties in the funds flow, and ultimately manages the payout to service providers, sellers, and consumers. Platforms and fintechs using Mangopay regain control and transparency over multi-party payment flows, generate additional revenue, and improve operational efficiency. They can stay compliant while innovating and scaling. Our team of 300+ people is spread across offices in Madrid, Paris, Warsaw, Berlin, Luxembourg and London. We're looking for talented individuals to join us in tackling the exciting challenges ahead. At Mangopay, you’ll be part of a supportive, diverse team committed to building scalable solutions and driving change in the fintech space! Job Description We are seeking a highly skilled and motivated Regulatory Compliance Expert to join our organization. The Regulatory Compliance Expert will be responsible for overseeing and ensuring the effective implementation of regulatory compliance initiatives, with a primary focus on Anti-Money Laundering (AML) and Counter-Terrorist Financing (CTF) obligations. The ideal candidate will possess a strong understanding of regulatory requirements, have excellent analytical and communication skills, and be able to work collaboratively across various departments. Responsibilities Establish and maintain internal controls to ensure compliance with AML/CTF obligations, including conducting regular reviews and assessments. Prepare and submit annual AML/CTF reports to relevant authorities, ensuring accuracy and timeliness. Reliance Framework Design: Develop and maintain the global policy for KYC Reliance, ensuring compliance with specific jurisdictional provisions. Act as the Subject Matter Expert (SME) during audits and regulatory examinations, defending our Reliance model and proving the efficacy of our testing protocols. Develop and update policies and procedures related to AML/CTF compliance, in line with regulatory guidelines and best practices. Design and implement a comprehensive training plan on AML/CTF, whistleblowing, conflict of interest, and anti-bribery and corruption, ensuring all employees are educated on compliance requirements. Collaborate with internal stakeholders to ensure effective dissemination of compliance policies and procedures throughout the organization. Act as the primary point of contact for internal and external auditors, coordinating audit activities, responding to inquiries, and addressing findings or recommendations. Monitor regulatory changes, assessing their impact on the organization, and proactively implementing necessary updates to policies, procedures, and training materials. Conduct periodic risk assessments to identify potential compliance gaps and develop strategies to mitigate risks. Stay informed about industry trends, best practices, and emerging regulatory requirements related to AML/CTF, and provide recommendations for process improvements or enhancements. Qualifications Bachelor’s degree in Business, Law, Finance, or related field. Minimum 5 years of Compliance experience within banking, payments, EMI or acquiring institutions. Proven track record in regulatory compliance with strong focus on AML/CTF, ideally including leadership or coordination responsibilities. Solid expertise in AML/CTF regulations, guidelines, and industry best practices, plus a broad understanding of financial services regulation. Strong grasp of internal control frameworks and risk management principles. Demonstrated ability to draft and maintain policies, procedures, and compliance reports. Excellent analytical and problem-solving skills, with high attention to detail. Excellent written and verbal communication in English and French, comfortable managing multiple priorities in a fast-changing regulatory environment. Knowledge of Salesforce and compliance/financial crime tools (fraud, AML, analytics solutions) is a plus. Additional information HR Call 1st Interview with Compliance Expert 2nd interview with Head of Compliance Last interview with VP Compliance We care about equal employment opportunities, so all qualified applicants will receive equal consideration regardless of their race, colour, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status.", "summaryDescription" : "Compliance Expert (Regulatory) at Mangopay. Skills: Regulatory compliance, AML/CTF, Risk assessment. Establish internal controls. Maintain internal controls", "postedDate" : "2026-06-14T04:45:52.171", "createdAt" : "2026-06-14T04:45:52.171", "lastUpdated" : "2026-06-15T11:36:01.964", "ingestTimestamp" : "2026-06-14T04:45:52.171", "mongoId" : "6a2c916274d8ee00a0982aab", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "50k-75k", "hasSalary" : false, "allSkills" : [ "Regulatory requirements", "AML/CTF obligations", "KYC Reliance", "Whistleblowing", "Conflict of interest", "Anti-bribery", "Corruption", "Regulatory compliance", "AML/CTF", "Risk assessment", "Risk management", "Legal analysis", "Compliance oversight", "Banking regulation", "Payments regulation", "EMI regulation", "Acquiring institutions", "Financial services regulation", "AML/CTF regulations", "Industry best practices" ], "skillCount" : 20, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Senior", "dataQualityScore" : 1.0, "_score" : 822.8812, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "FinTech", "llmIndustryConfidence" : 0.97 }, { "id" : "6a308009f292fd229c060e2f", "title" : "[L&C] Regulatory (Product) Counsel", "company" : "Bybit", "industry" : "FinTech", "salary" : { "min" : 1050000.0, "max" : 1650000.0, "currency" : "HKD", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for FinTech in Hong Kong, adjusted for mid-seniority level." }, "location" : "Hong Kong SAR", "locations" : [ "Hong Kong SAR" ], "timestamp" : "2026-06-16T11:27:34.252", "fingerprint" : "a0beda4021fe96d461230a180208e10dcb7958eb7d6ef8144c079fabb9855899", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.eu.greenhouse.io/bybit/jobs/4875932101", "externalId" : "4875932101", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Hong Kong", "state" : "Hong Kong SAR", "country" : "China", "continent" : "as", "source" : "llm", "workMode" : "onsite", "geo" : "22.2818333,114.1582831" } ], "locationText" : "Hong Kong, Hong Kong SAR, China", "professionalSkills" : [ "Regulatory advisory", "Financial services law", "Technology law", "Product advisory", "Risk mitigation", "Product governance", "Regulatory engagement", "Risk assessment" ], "hardSkillsList" : [ "Regulatory gap analysis", "Product compliance frameworks", "Multi-jurisdictional analysis", "Risk-based advice" ], "hardSkills" : [ { "name" : "Regulatory gap analysis", "level" : "intermediate" }, { "name" : "Product compliance frameworks", "level" : "intermediate" }, { "name" : "Multi-jurisdictional analysis", "level" : "intermediate" }, { "name" : "Risk-based advice", "level" : "intermediate" } ], "majorSkills" : "Regulatory law, Product advisory, Crypto products, Jurisdictional analysis", "majorSkillsList" : [ "Regulatory law", "Product advisory", "Crypto products", "Jurisdictional analysis" ], "coreResponsibilities" : "Serve as legal and regulatory advisor for new, Conduct regulatory gap analyses for target jurisdictions, Develop product compliance frameworks, Advise on regulatory constraints, Assess regulatory classification of products, Monitor global regulatory developments, Flag risks and opportunities, Coordinate with Licensing Counsel, Align product launch timelines, Support development of internal approval processes, Prepare regulatory risk assessments, Prepare internal memos", "teamCollaboration" : "Advise Product, Tech, Business and Fiat teams; Coordinate with Licensing Counsel; Work with internal teams", "domainKnowledge" : "Cryptocurrency product structures; Spot trading; Derivatives; Lending; Staking; Earn products; Launchpad offerings; Copy trading; Digital asset products; Perpetuals; Structured products; Consumer protection regulations; Advertising regulations; Marketing regulations", "domainList" : [ "cryptocurrency-product-structures", "spot-trading", "derivatives", "lending", "staking", "earn-products", "launchpad-offerings", "copy-trading", "digital-asset-products", "perpetuals", "structured-products", "consumer-protection-regulations", "advertising-regulations", "marketing-regulations" ], "domainSpecificKnowledge" : [ "Cryptocurrency product structures", "Spot trading", "Derivatives", "Lending", "Staking", "Earn products", "Launchpad offerings", "Copy trading", "Digital asset products", "Perpetuals", "Structured products", "Consumer protection regulations", "Advertising regulations", "Marketing regulations" ], "communicationSkills" : "Written communication; Verbal communication", "continuousLearning" : "Study Growth Fund", "problemSolvingSkills" : "Problem-solving skills; Navigating regulatory ambiguity", "qualificationsBasic" : "Law degree (LLB, JD, or equivalent), 3-6 years experience in regulatory law, financial services law, or technology law or crypto, Understanding of cryptocurrency product structures, Ability to conduct multi-jurisdictional regulatory analysis, Excellent analytical and problem-solving skills, Direct experience advising on crypto or digital asset products at an exchange, fintech, or financial institution", "qualificationsPreferred" : "Admission to practice in at least one jurisdiction, Written and verbal communication in additional languages especially Chinese, Familiarity with regulatory treatment of derivatives, perpetuals, and structured products in key jurisdictions, Experience with product governance frameworks, Prior in-house experience in a high-growth technology or fintech company", "rawDescription" : "About Us Established in 2018, Bybit is one of the world’s leading cryptocurrency exchanges and digital financial platforms, serving over 80 million users across more than 200 countries and regions. Powered by world-class technology and a user-first mindset, Bybit delivers a seamless ecosystem across trading, payments, wealth management, custody, institutional services, and Web3 — connecting users to the future of digital finance. Our core values define how we build. We listen, care and improve to create products and experiences that put users first. Backed by a global team of ambitious builders, problem-solvers, and innovators, we foster a high-performance and fast-moving environment where talent is empowered to drive real impact at the global scale. Supported by 24/7 multilingual customer service and a strong commitment to innovation, we are shaping the future of finance through technology, collaboration, and bold execution. Today, Bybit is recognized as one of the most trusted and transparent platforms in the digital asset industry, continuing to expand its global presence while building the infrastructure for the next generation of financial services. Key Responsibilities Serve as the primary legal and regulatory advisor for new product launches, features, and initiatives on the global platform being involved end to end in the launch of new products Conduct regulatory gap analyses for target jurisdictions to assess the permissibility and risk profile of product offerings in markets where the exchange has not yet obtained local licenses Develop and maintain product compliance frameworks, playbooks, and decision matrices for the global product team Advise Product, Tech, Business and Fiat teams on regulatory constraints, user eligibility requirements, geo-restrictions, and risk mitigation strategies aligning these with internal guidelines Assess regulatory classification of products (spot trading, derivatives, lending, staking, earn products, launchpad offerings, copy trading, etc.) across jurisdictions Monitor global regulatory developments affecting product permissibility and proactively flag risks and opportunities to the business Coordinate with Licensing Counsel and external advisors to align product launch timelines with licensing strategy and regulatory engagement Support the development of internal approval processes (product governance review processes, sign-off workflows) for new product rollouts Prepare regulatory risk assessments and internal memos to support product decisions by senior leadership Requirements Law degree (LLB, JD, or equivalent); admission to practice in at least one jurisdiction is preferred 3-6 years of experience in regulatory law, financial services law, or technology law or crypto — with exposure to product advisory, fntech or crypto Understanding of cryptocurrency product structures (spot, derivatives, perpetuals, lending, staking, earn, NFTs) and their regulatory treatment across jurisdictions Ability to conduct multi-jurisdictional regulatory analysis and present findings in clear, commercially actionable terms Excellent analytical and problem-solving skills — comfortable navigating regulatory ambiguity and providing risk-based advice Strong written and verbal communication in English; additional languages especially Chinese are a plus Collaborative mindset and a good team player with the ability to work closely with internal teams as well as independently Fast learner, able to hit the ground running. takes ownership of projects, has pride in the work Direct experience advising on crypto or digital asset products at an exchange, fintech, or financial institution Familiarity with regulatory treatment of derivatives, perpetuals, and structured products in key jurisdictions (e.g., ADGM, SFC, FCA, VARA) Experience with product governance frameworks and new product approval processes Understanding of consumer protection, advertising, and marketing regulations applicable to crypto products Prior in-house experience in a high-growth technology or fintech company Why Join Us At Bybit, we are committed to fostering a supportive and enriching work environment. Our benefits include: - Study Growth Fund: We support your professional development and continuous learning. - Internal Events: Participate in regular team-building activities, workshops, and events designed to promote collaboration and innovation. - Global Collaboration: Be part of a diverse, international team, working alongside colleagues from around the world. - Career Advancement: Access opportunities for growth and advancement within a rapidly expanding global company. - Internal Mobility: Grow with us- Your long-term development is important to us. We offer internal job opportunities to help build your career path.", "summaryDescription" : "[L&C] Regulatory (Product) Counsel at Bybit. Skills: Regulatory law, Product advisory, Crypto products, Jurisdictional analysis. Serve as legal and regulatory advisor for new. Conduct regulatory gap analyses for target jurisdictions", "postedDate" : "2026-06-16T01:21:21.538", "createdAt" : "2026-06-16T01:21:21.538", "lastUpdated" : "2026-06-16T11:27:34.252", "ingestTimestamp" : "2026-06-16T01:21:21.538", "mongoId" : "6a308009f292fd229c060e2f", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "200k+", "hasSalary" : false, "allSkills" : [ "Regulatory gap analysis", "Product compliance frameworks", "Multi-jurisdictional analysis", "Risk-based advice", "Regulatory law", "Product advisory", "Crypto products", "Jurisdictional analysis", "Regulatory advisory", "Financial services law", "Technology law", "Risk mitigation", "Product governance", "Regulatory engagement", "Risk assessment", "Cryptocurrency product structures", "Spot trading", "Derivatives", "Lending", "Staking", "Earn products", "Launchpad offerings", "Copy trading", "Digital asset products", "Perpetuals", "Structured products", "Consumer protection regulations", "Advertising regulations", "Marketing regulations" ], "skillCount" : 29, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Mid", "dataQualityScore" : 0.7777778, "_score" : 816.8364, "daysOld" : 0, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "FinTech", "llmIndustryConfidence" : 0.98 }, { "id" : "6a2c6af174d8ee00a090f537", "title" : "Regulatory Licensing Counsel", "company" : "Bybit", "industry" : "FinTech", "salary" : { "min" : 350000.0, "max" : 550000.0, "currency" : "AED", "frequency" : "yearly", "is_estimated" : true, "estimation_basis" : "Market baseline for a Mid-level Regulatory Licensing Counsel in Abu Dhabi, UAE, within the FinTech industry, adjusted for company size and seniority." }, "location" : "Abu Dhabi", "locations" : [ "Abu Dhabi" ], "timestamp" : "2026-06-15T09:22:26.966", "fingerprint" : "bbe051798eab05d4ec4a0faf52205a896c52ab6b21c911a5508221d0b5c71e15", "source" : "greenhouse", "language" : "en", "applyUrl" : "https://job-boards.eu.greenhouse.io/bybit/jobs/4860987101", "externalId" : "4860987101", "industryFunction" : { }, "structuredLocations" : [ { "city" : "Abu Dhabi", "country" : "United Arab Emirates", "continent" : "as", "source" : "llm", "workMode" : "onsite", "geo" : "24.4538352,54.3774014" } ], "locationText" : "Abu Dhabi, United Arab Emirates", "employmentType" : "FULL_TIME", "professionalSkills" : [ "Regulatory law", "Licensing", "Compliance oversight", "Risk management", "Legal analysis", "Project management", "Jurisdictional assessments", "Regulatory engagement", "Information gathering", "Stakeholder alignment", "Relationship building" ], "hardSkillsList" : [ "Licensing applications", "Regulatory requirements", "Business plans", "Regulatory questionnaires", "Licensing tracker maintenance", "Condition monitoring", "Variation applications", "Periodic reporting", "Internal briefings", "Status reports" ], "softSkillsList" : [ "Collaborative mindset", "Takes ownership" ], "hardSkills" : [ { "name" : "Licensing applications", "level" : "intermediate" }, { "name" : "Regulatory requirements", "level" : "intermediate" }, { "name" : "Business plans", "level" : "intermediate" }, { "name" : "Regulatory questionnaires", "level" : "intermediate" }, { "name" : "Licensing tracker maintenance", "level" : "intermediate" }, { "name" : "Condition monitoring", "level" : "intermediate" }, { "name" : "Variation applications", "level" : "intermediate" }, { "name" : "Periodic reporting", "level" : "intermediate" }, { "name" : "Internal briefings", "level" : "intermediate" }, { "name" : "Status reports", "level" : "intermediate" } ], "softSkills" : [ { "name" : "Collaborative mindset" }, { "name" : "Takes ownership" } ], "majorSkills" : "Regulatory licensing, Licensing applications, Regulatory engagement, Jurisdictional assessments", "majorSkillsList" : [ "Regulatory licensing", "Licensing applications", "Regulatory engagement", "Jurisdictional assessments" ], "coreResponsibilities" : "Lead licensing process, Manage licensing process, Prepare licence applications, Submit licence applications, Engage with regulators, Conduct jurisdictional assessments, Evaluate licensing requirements, Evaluate timelines, Evaluate strategic feasibility, Prepare licensing applications, Draft licensing applications, Coordinate licensing applications, Coordinate supporting documentation, Coordinate business plans, Coordinate regulatory questionnaires, Liaise with regulators, Liaise with external counsel, Liaise with government authorities, Monitor regulatory developments, Maintain licensing tracker, Manage licensing tracker, Coordinate with internal stakeholders, Gather information, Align on licensing requirements, Support post-licensing compliance, Monitor conditions, Support variation applications, Support periodic reporting, Prepare internal briefings, Prepare status reports, Build relationships, Maintain relationships", "teamCollaboration" : "Internal stakeholders; External legal advisors; Globally distributed team", "projectManagementSkills" : [ "Project management", "Manage multiple workstreams" ], "domainKnowledge" : "Virtual asset service providers; Financial institutions; AML/CFT requirements; Crypto licensing; Digital asset licensing", "domainList" : [ "virtual-asset-service-providers", "financial-institutions", "aml-cft-requirements", "crypto-licensing", "digital-asset-licensing" ], "domainSpecificKnowledge" : [ "Virtual asset service providers", "Financial institutions", "AML/CFT requirements", "Crypto licensing", "Digital asset licensing" ], "communicationSkills" : "Written communication; Verbal communication; Internal briefings; Status reports", "documentationSkills" : "Drafting; Supporting documentation; Business plans; Regulatory questionnaires", "continuousLearning" : "Study Growth Fund", "problemSolvingSkills" : "Analytical skills", "qualificationsBasic" : "Law degree, Admission to practice, 2-5 years experience, Financial services or crypto licensing, Licence applications experience, Regulatory approvals experience, Global licensing frameworks understanding, Legal research skills, Drafting skills, Analytical skills, Project management skills, Manage multiple licensing workstreams", "qualificationsPreferred" : "Direct cryptocurrency licensing experience, Digital asset licensing experience, VASP registrations experience, MAS MPI experience, VARA licences experience, EU MiCA authorisations experience, ADGM licences experience, APAC licensing regimes familiarity, MENA licensing regimes familiarity, Europe licensing regimes familiarity, Latin America licensing regimes familiarity, Experience with regulators concurrently, AML/CFT requirements understanding, In-house experience, Fintech firm experience, Global financial services firm experience, Law firm experience", "rawDescription" : "About Us Established in 2018, Bybit is one of the world’s leading cryptocurrency exchanges and digital financial platforms, serving over 80 million users across more than 200 countries and regions. Powered by world-class technology and a user-first mindset, Bybit delivers a seamless ecosystem across trading, payments, wealth management, custody, institutional services, and Web3 — connecting users to the future of digital finance. Our core values define how we build. We listen, care and improve to create products and experiences that put users first. Backed by a global team of ambitious builders, problem-solvers, and innovators, we foster a high-performance and fast-moving environment where talent is empowered to drive real impact at the global scale. Supported by 24/7 multilingual customer service and a strong commitment to innovation, we are shaping the future of finance through technology, collaboration, and bold execution. Today, Bybit is recognized as one of the most trusted and transparent platforms in the digital asset industry, continuing to expand its global presence while building the infrastructure for the next generation of financial services. We are looking for a Licensing Counsel to drive and manage licensing initiatives across multiple jurisdictions globally. This role sits at the heart of our market access strategy, responsible for navigating regulatory licensing regimes, preparing and managing licence applications, and ensuring the exchange maintains and expands its authorisations worldwide. The ideal candidate has hands-on experience with financial services or crypto licensing and thrives in a fast-moving, multi-jurisdictional environment. Key Responsibilities Lead and manage the end-to-end licensing process for new market entries globally, including application preparation, submission, and regulatory engagement Conduct jurisdictional assessments to evaluate licensing requirements, timelines and strategic feasibility for target markets and to support the expansion requirements of the company Prepare, draft, and coordinate licensing applications, supporting documentation, business plans, and regulatory questionnaires Liaise directly with regulators, external counsel, and government authorities across jurisdictions to advance licensing matters Monitor global regulatory developments that may create new licensing obligations or opportunities for the exchange Maintain and manage a global licensing tracker covering application status, renewal deadlines, conditions, and ongoing obligations Coordinate with internal stakeholders (Legal, Compliance, Finance, Operations, Product) to gather information and align on licensing requirements Support post-licensing compliance, including condition monitoring, variation applications, and periodic reporting to regulators (where applicable) Prepare internal briefings and status reports on licensing progress for senior leadership Build and maintain relationships with external legal advisors across jurisdictions to support licensing activities Requirements Law degree (LLB, JD, or equivalent); admission to practice in at least one jurisdiction is preferred 2-5 years of experience in regulatory law, licensing, or compliance — with meaningful exposure to financial services, fintech, or cryptocurrency (preference) Demonstrated experience with licence applications or regulatory approvals (e.g., VASP, MPI, EMI, broker-dealer, or equivalent authorisations) Understanding of global licensing frameworks for virtual asset service providers and/or financial institutions Strong legal research, drafting, and analytical skills with the ability to distil complex regulatory requirements into actionable advice Excellent project management skills — ability to manage multiple licensing workstreams across jurisdictions simultaneously Strong written and verbal communication in English; additional languages relevant to target jurisdictions are a plus Comfortable working in a fast-paced, decentralised, and globally distributed team Collaborative mindset and a good team player with the ability to work closely with internal teams as well as independently Fast learner, able to hit the ground running. takes ownership of projects, has pride in the work Preferred Qualifications Direct experience with cryptocurrency or digital asset licensing preferred but not an absolute must (VASP registrations, MAS MPI, VARA licences, EU MiCA authorisations, ADGM licences etc.) Familiarity with key licensing regimes in APAC, MENA, Europe, or Latin America Experience working with regulators across multiple jurisdictions concurrently Understanding of AML/CFT requirements as they relate to licensing conditions and ongoing obligations Prior in-house experience at a crypto exchange, fintech, or global financial services firm would be seen favourably but candidates with law firm experience will not be discounted Why Join Us At Bybit, we are committed to fostering a supportive and enriching work environment. Our benefits include: - Study Growth Fund: We support your professional development and continuous learning. - Internal Events: Participate in regular team-building activities, workshops, and events designed to promote collaboration and innovation. - Global Collaboration: Be part of a diverse, international team, working alongside colleagues from around the world. - Career Advancement: Access opportunities for growth and advancement within a rapidly expanding global company. - Internal Mobility: Grow with us- Your long-term development is important to us. We offer internal job opportunities to help build your career path.", "summaryDescription" : "Regulatory Licensing Counsel at Bybit. Skills: Regulatory licensing, Licensing applications, Regulatory engagement, Jurisdictional assessments. Lead licensing process. Manage licensing process", "postedDate" : "2026-06-14T03:40:07.267", "createdAt" : "2026-06-14T03:40:07.267", "lastUpdated" : "2026-06-15T09:22:26.966", "ingestTimestamp" : "2026-06-14T03:40:07.267", "mongoId" : "6a2c6af174d8ee00a090f537", "processingStatus" : "llm_updated", "llmProcessingStatus" : true, "salaryBand" : "200k+", "hasSalary" : false, "allSkills" : [ "Licensing applications", "Regulatory requirements", "Business plans", "Regulatory questionnaires", "Licensing tracker maintenance", "Condition monitoring", "Variation applications", "Periodic reporting", "Internal briefings", "Status reports", "Collaborative mindset", "Takes ownership", "Regulatory licensing", "Regulatory engagement", "Jurisdictional assessments", "Regulatory law", "Licensing", "Compliance oversight", "Risk management", "Legal analysis", "Project management", "Information gathering", "Stakeholder alignment", "Relationship building", "Manage multiple workstreams", "Virtual asset service providers", "Financial institutions", "AML/CFT requirements", "Crypto licensing", "Digital asset licensing" ], "skillCount" : 30, "jobCategory" : "operations", "jobSubcategory" : "legal", "seniorityLevel" : "Mid", "dataQualityScore" : 0.8888889, "_score" : 809.5146, "daysOld" : 1, "hasLocation" : true, "hasGeo" : true, "llmIndustry" : "FinTech", "llmIndustryConfidence" : 0.97 } ], "status" : 200, "message" : "OK", "pagination" : { "page" : 0, "limit" : 50, "totalCount" : 21225, "totalPages" : 425, "hasNext" : true, "hasPrevious" : false } }

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