Director, Regulatory Affairs CMC
Vertex Pharmaceuticals · Boston, MA
RegulatoryFull-time$190k–$286kCompany career page
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Role summary
Director leading Chemistry Manufacturing Controls regulatory strategy for small molecule products at a global biotechnology company. Oversees CMC submissions, Health Authority interactions, and team development while driving process innovation and AI-enabled regulatory capabilities.
What they're looking for
- Bachelor's degree in Chemistry, Biology, Pharmacy, Regulatory Affairs, or related life sciences field
- 10+ years pharmaceutical or biotechnology industry experience in small molecule development
- 3+ years people management experience leading technical and regulatory professionals
- Comprehensive knowledge of FDA, EMA, Health Canada, ICH, and global CMC requirements
- Demonstrated experience developing and executing global CMC regulatory strategies
- Advanced strategic thinking, regulatory risk assessment, and leadership skills
- Knowledge of digital regulatory trends, structured content, data governance, and AI applications
What you'll be doing
- Lead development and execution of global CMC regulatory strategies across multiple investigational and commercial small molecule products
- Oversee preparation, review, and approval of CMC content for global regulatory submissions
- Provide strategic leadership for Health Authority interactions, negotiations, and senior governance body representation
- Build, mentor, and develop high-performing Regulatory CMC team through coaching and talent development
- Champion AI-enabled technologies and continuous process improvements for regulatory decision-making and dossier preparation
Privacy & handoff
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