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Regulatory CMC Manager – Contract
Vertex PharmaceuticalsRegulatory CMC Manager supporting cell and gene therapy regulatory strategies for Vertex Pharmaceuticals. Involved in regulatory submissions and providing guidance to cross-functional teams.
About the role
Key responsibilities & impact- Support the execution of cell and gene therapy regulatory CMC strategies for marketed products
- Contributes to the planning, preparation and submission of regulatory CMC documentation
- Provides regulatory support and guidance to various cross functional teams
- Planning and execution of international regulatory CMC submissions, including creation of content plans
- Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
- Contributes to the development of global regulatory CMC strategies for commercial products
- Works with regulatory and technical colleagues to ensure timely submission and approval of CMC changes in the post approval environment
- Provides regulatory CMC guidance to cross-functional teams and key stakeholders
- Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Requirements
What you’ll need- Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- 5 years of Regulatory CMC experience, preferably in the biologics or cell and gene therapy field
- Strong interpersonal skills to exchange complex information with others and to guide others
- Proficiency in FDA, EMA and international regulatory guidelines
- Experience in the preparation, reviews and submissions of CMC post approval variations
- Strong sense of planning, strategic thinking and problem-solving skills
- Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
- Capable of strategic thinking with ability to resolve complex and ambiguous situations
Benefits
Comp & perks- Eligible for overtime pay in accordance with federal and state requirements
ATS Keywords
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Hard Skills & Tools
Regulatory CMCCMC documentationRegulatory submissionsGMP investigationsPost approval variationsRegulatory assessmentChange controlsBiologicsCell and gene therapyStrategic planning
Soft Skills
Interpersonal skillsStrategic thinkingProblem-solvingCollaborationCommunication
Certifications
Bachelor's degree in BiologyBachelor's degree in ChemistryBachelor's degree in PharmacyBachelor's degree in Regulatory AffairsBachelor's degree in Medical Devices