Lilly
Healthcare
RegulatoryManager
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“Regulatory Manager at Lilly. Skills: Regulatory affairs, Regulatory compliance, Labelling. Support establishing local regulatory strategy. Ensure local plan aligns to global strategy”
What You'll Achieve.
Achieve regulatory objectives; Support affiliate launch plan; Ensure high efficiencies of submission operations; Improve market performance outcomes
Industry & Context.
Issue management
What They're Looking For.
Must Have
Bachelor's degree in pharmacy, At least 8 years industry related experience in regulatory affairs, Knowledge of local/regional regulatory procedures and practices, Knowledge of drug development process, Demonstrated good information technology skills, Good knowledge of written and spoken English, Understand internal business complexities, Ability to demonstrate added value of regulatory in business
Nice to Have
Knowledge of Quality systems, Strategic thinking and decision making
What You'll Do.
Support establishing local regulatory strategy
Ensure local plan aligns to global strategy
Ensure local regulations and business needs are included
Provide regulatory expertise
Deliver high quality regulatory submissions
Deliver efficient regulatory submissions
Deliver local labelling
Foster operational excellence
Provide influence to local regulatory authority
Achieve regulatory objectives
Maintain regulatory activities at Ankara office
Collaborate with implementation of regulatory plan
Ensure submission and approval of high-quality applications
Maintain clear metrics for deliverables
Preparation of new applications
Support of new applications
Obtain marketing authorizations
Present affiliate's perspectives
Present affiliate's needs
Ensure timely responses to requests
Maintain marketing authorizations
Submit post approval maintenance activities
Submit periodic reports
Collaborate with GRA Regional Regulatory Team
Ensure use of regulatory tools
Ensure submission tracking
Ensure management of submissions
Update regulatory requirements
Monitor regulatory plans
Ensure products comply with local regulations
Ensure products comply with quality system requirements
Implement robust processes
Keep regulatory archive complete
Keep regulatory archive up-to-date
Ensure current licenses are available
Ensure current labels are available
Ensure local quality system aligns with global quality
Ensure local quality system aligns with local regulations
Support regulatory quality audits
Support regulatory quality inspections
Support corrective and preventive actions
Provide regulatory quality oversight for external parties
Perform assessment of regulatory compliance information
Communicate regulatory compliance information
Lead regulatory audits
Lead regulatory inspections
Coordinate implementation of corrective/preventive actions
Lead regulatory quality oversight for external parties
Perform function of Alternate Affiliate Labelling Responsible Person
Perform function of Delegate Affiliate Labelling Responsible Person
Ensure product information complies with local regulatory requirements
Ensure updated product information is submitted
Ensure updated product information is approved
Ensure updated product information is implemented
Ensure adherence with global labelling procedures
Document relevant exceptions
Produce accurate product information
Produce high-quality product information
Perform function of Primary Affiliate Labelling Responsible Person
Identify local process improvement opportunities
Ensure implementation of global regulatory initiatives
Participate in affiliate launch teams
Anticipate regulatory outcomes
Deliver regulatory outcomes
Represent Regulatory Affairs in New Product Planning
Interact directly with regulatory bodies
Facilitate interactions with regulatory bodies
Ensure impactful influence with regulators
Voice affiliate needs
Voice affiliate perspectives
Raise awareness on compliance issues
Raise awareness on compliance initiatives
Provide technical support to other affiliate functions
Represent Lilly in industry association meetings
Gather regulatory intelligence
Gather information from local regulatory environments
Gather information from global regulatory environments
Develop product-specific strategies
Develop general strategies
Improve market performance outcomes
Create positive working environment
Maintain effective working environment
Support Director in developing influencing strategy
Define affiliate's position on regulatory issues
Outline recommended action plans for interactions with regulators
Secure appointments with regulatory officials
Collaborate with Affiliate cross functional teams
Secure timely submissions
Secure timely approvals
Monitor Lilly's performance versus market
How You'll Work.
Team & Collaboration
Affiliate cross-functional teams; GRA functions; Cross-functional teams; Global regulatory contacts; Regional regulatory contacts; Support groups; Regulatory Authorities; GRA Regional Regulatory Team; Appropriate management; Cross-functional experts; Affiliate launch teams; New Product Planning discussions; Regulatory Quality Organization; External parties; Regulatory affairs services providers; Translators; Graphic agencies; Leadership; Relevant functions; Industry association meetings; Commercial teams; Medical teams; Quality teams
Communication Scope
Effective communication; Effective negotiation; Effective communication and negotiation; Effective communication and negotiation skills
Process & Methodology
Planning, Priority setting, Project management, Process management
Full Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. **Regulatory Manager – Ankara, Global Regulatory Affairs (GRA)** Regulatory Manager- Ankara, Global Regulatory Affairs (GRA) - Regulatory Affiliate is accountable to support establishing the local regulatory strategy and plan for assigned product(s) in country, ensure local plan aligns to the global regulatory strategy and ensure local regulations and region/country business needs are included. The Manager is accountable to provide regulatory expertise in the delivery of high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s), and foster an environment of operational excellence in collaboration with cross-functional teams and provide influence to the local regulatory authority to successfully achieve regulatory objectives. The Manager is also responsible for Regulatory Policy and HA Relations and maintains the Regulatory activities at Ankara office **Primary Responsibilities** **Effective Regulatory Plan Execution and Strategy** * Collaborate with the implementation of the regulatory plan in collaboration with GRA functions and affiliate cross-functions in alignment with affiliate business plans as well as regulatory requirements. * Ensure submission and approval of high-quality regulatory applications within planned timelines. Maintain or support maintenance of clear metrics for Regulatory deliverables. * Preparation and support of new applications to obtain marketing au
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