Associate Director, Regulatory CMC, Biologics
Vertex Pharmaceuticals · Boston, MA
RegulatoryFull-time$166k–$250kCompany career page
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Role summary
Associate Director of Regulatory CMC for biologics who will lead global regulatory strategy, author and review CMC submissions for investigational and commercial products, and serve as the primary Health Authority interface. The role emphasizes integration of AI and digital tools to enhance regulatory document quality and efficiency.
What they're looking for
- Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science field
- 8+ years pharmaceutical or biotechnology industry experience focused on biologics
- Advanced knowledge of global regulatory CMC requirements (FDA, EMA, ICH, Health Canada)
- Experience leading CMC regulatory submissions and Health Authority interactions for biologics
- Strategic thinking, problem-solving, and cross-functional team leadership abilities
- Working knowledge of AI tools for regulatory document preparation and review
- Experience with structured content, data-driven authoring, and digital submissions
What you'll be doing
- Lead preparation, review, and lifecycle management of CMC sections in global regulatory submissions
- Develop and execute global CMC regulatory strategies for assigned biologic programs
- Serve as primary CMC regulatory lead for Health Authority interactions and communications
- Lead regulatory assessment of CMC changes, deviations, and investigations
- Apply AI-enabled tools for document authoring, review, and consistency checks
Privacy & handoff
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