Associate Director, Regulatory CMC, Biologics
Vertex Pharmaceuticals
August 21, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
General Summary:
- The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial biologics products, authoring/reviewing/delivering high-quality regulatory submissions and serving as the primary CMC interface with Health Authorities, using digital and AI-enabled approaches to improve document preparation and review.
Key Duties And Responsibilities:
- Lead preparation, review, and lifecycle management of CMC sections of global regulatory submissions for biologics (INDs/CTAs, NDAs/BLAs/MAAs)
- Develop and drive global CMC regulatory strategies for assigned programs
- Serve as primary CMC lead for Health Authority interactions
- Provide regulatory guidance to cross-functional teams
- Lead regulatory assessment of CMC changes, deviations, and investigations
- Apply AI-enabled tools for authoring, review, and consistency checks
- Drive structured content and data traceability approaches; support AI/digital capability development
- Contribute to process improvements and innovation; represent Regulatory CMC in governance forums
- Stay current on emerging technologies (including AI), automation, and regulatory environment changes
Knowledge And Skills:
- Advanced knowledge of global regulatory CMC requirements (FDA, EMA, ICH, Health Canada) for biologics
- Strategic thinking, problem solving, excellent communication
- Ability to lead/influence cross-functional teams; strong planning/prioritization
- Ability to work in a global matrix environment; commitment to quality/compliance
Digital & AI-Enabled Regulatory Capabilities:
- Working knowledge of AI tools for regulatory document preparation/review
- Experience with structured, data-driven authoring; critically review AI-assisted outputs
- Familiarity with digital submission and data integrity expectations; identify automation/AI opportunities
Education And Experience:
- Bachelor’s degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science (advanced degree preferred)
- 8+ years in pharma/biotech with a focus on biologics
- Experience leading CMC regulatory submissions and HA interactions for biologics; complex/multi-product strategies preferred
Pay Range (if applicable): $166,400 - $249,600
- The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial biologics products, authoring/reviewing/delivering high-quality regulatory submissions and serving as the primary CMC interface with Health Authorities, using digital and AI-enabled approaches to improve document preparation and review.
Key Duties And Responsibilities:
- Lead preparation, review, and lifecycle management of CMC sections of global regulatory submissions for biologics (INDs/CTAs, NDAs/BLAs/MAAs)
- Develop and drive global CMC regulatory strategies for assigned programs
- Serve as primary CMC lead for Health Authority interactions
- Provide regulatory guidance to cross-functional teams
- Lead regulatory assessment of CMC changes, deviations, and investigations
- Apply AI-enabled tools for authoring, review, and consistency checks
- Drive structured content and data traceability approaches; support AI/digital capability development
- Contribute to process improvements and innovation; represent Regulatory CMC in governance forums
- Stay current on emerging technologies (including AI), automation, and regulatory environment changes
Knowledge And Skills:
- Advanced knowledge of global regulatory CMC requirements (FDA, EMA, ICH, Health Canada) for biologics
- Strategic thinking, problem solving, excellent communication
- Ability to lead/influence cross-functional teams; strong planning/prioritization
- Ability to work in a global matrix environment; commitment to quality/compliance
Digital & AI-Enabled Regulatory Capabilities:
- Working knowledge of AI tools for regulatory document preparation/review
- Experience with structured, data-driven authoring; critically review AI-assisted outputs
- Familiarity with digital submission and data integrity expectations; identify automation/AI opportunities
Education And Experience:
- Bachelor’s degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science (advanced degree preferred)
- 8+ years in pharma/biotech with a focus on biologics
- Experience leading CMC regulatory submissions and HA interactions for biologics; complex/multi-product strategies preferred
Pay Range (if applicable): $166,400 - $249,600