Director, Regulatory Affairs CMC
Vertex Pharmaceuticals
August 19, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
General Summary:
The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio.
Key Duties and Responsibilities:
- Lead development and execution of global CMC regulatory strategies for multiple investigational and marketed products.
- Oversee preparation, review, and approval of CMC content for global regulatory submissions.
- Provide strategic leadership for Health Authority interactions and negotiations.
- Lead and develop Regulatory CMC staff through coaching and talent development.
- Ensure consistent regulatory guidance to cross-functional stakeholders.
- Serve as senior Regulatory CMC representative on governance bodies and product teams.
- Identify regulatory risks and develop mitigation strategies.
- Drive continuous improvement through structured content and digital regulatory capabilities.
- Champion AI-enabled technologies for authoring, review, data traceability, and knowledge management.
- Ensure programs are appropriately resourced and accountable for regulatory milestones.
- Stay current on emerging technologies, including AI, and maintain a continuous learning mindset.
Knowledge and Skills:
- Comprehensive knowledge of FDA, EMA, Health Canada, ICH, and global CMC requirements.
- Advanced strategic thinking and regulatory risk assessment.
- Exceptional communication, negotiation, and leadership; ability to influence senior leaders.
- Strong organizational and resource planning; proven ability to build high-performing teams.
- Knowledge of digital regulatory trends, structured content, data governance, and AI applications.
- Experience leveraging AI-enabled tools for dossier preparation and knowledge management; ability to evaluate AI-generated content.
- Experience implementing technology-enabled process improvements in regulated environments (preferred).
Education and Experience:
- Bachelor’s in a relevant field (Chemistry, Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences, Engineering, or related life sciences); M.S./Pharm.D./Ph.D. preferred.
- 10+ years in pharmaceutical/biotech supporting small molecule development.
- 3+ years of people management experience.
- Experience developing/executing global CMC regulatory strategies and leading major submissions/Health Authority interactions.
- Experience driving organizational change and process improvements.
Pay Range: $190,400 - $285,600
The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio.
Key Duties and Responsibilities:
- Lead development and execution of global CMC regulatory strategies for multiple investigational and marketed products.
- Oversee preparation, review, and approval of CMC content for global regulatory submissions.
- Provide strategic leadership for Health Authority interactions and negotiations.
- Lead and develop Regulatory CMC staff through coaching and talent development.
- Ensure consistent regulatory guidance to cross-functional stakeholders.
- Serve as senior Regulatory CMC representative on governance bodies and product teams.
- Identify regulatory risks and develop mitigation strategies.
- Drive continuous improvement through structured content and digital regulatory capabilities.
- Champion AI-enabled technologies for authoring, review, data traceability, and knowledge management.
- Ensure programs are appropriately resourced and accountable for regulatory milestones.
- Stay current on emerging technologies, including AI, and maintain a continuous learning mindset.
Knowledge and Skills:
- Comprehensive knowledge of FDA, EMA, Health Canada, ICH, and global CMC requirements.
- Advanced strategic thinking and regulatory risk assessment.
- Exceptional communication, negotiation, and leadership; ability to influence senior leaders.
- Strong organizational and resource planning; proven ability to build high-performing teams.
- Knowledge of digital regulatory trends, structured content, data governance, and AI applications.
- Experience leveraging AI-enabled tools for dossier preparation and knowledge management; ability to evaluate AI-generated content.
- Experience implementing technology-enabled process improvements in regulated environments (preferred).
Education and Experience:
- Bachelor’s in a relevant field (Chemistry, Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences, Engineering, or related life sciences); M.S./Pharm.D./Ph.D. preferred.
- 10+ years in pharmaceutical/biotech supporting small molecule development.
- 3+ years of people management experience.
- Experience developing/executing global CMC regulatory strategies and leading major submissions/Health Authority interactions.
- Experience driving organizational change and process improvements.
Pay Range: $190,400 - $285,600