Director, Regulatory Affairs CMC
About The Position
The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial small-molecule products. The role provides strategic leadership for complex regulatory CMC activities, oversees Health Authority engagement, and ensures regulatory requirements are integrated into development and commercialization plans. The Director drives organizational excellence through talent development, process innovation, and digital and AI-enabled capabilities that improve the quality, consistency, and efficiency of regulatory decision-making, document preparation, and submission execution. The role may include budgetary and direct people-management accountability. Vertex describes the position as hybrid-eligible or on-site eligible. Hybrid employees may work remotely up to two days per week; on-site employees work five days per week on-site, with ad hoc flexibility. The position is eligible for an annual bonus and annual equity awards. Vertex also describes benefits including medical, dental and vision coverage, paid time off, a week-long summer and winter company shutdown, educational assistance programs including student loan repayment, commuting subsidy, matching charitable donations, and a 401(k).
Requirements
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences, Engineering, or a related life sciences discipline.
- At least 10 years of pharmaceutical, biotechnology, or related industry experience supporting small-molecule development.
- At least 3 years of people-management experience leading technical and/or regulatory professionals.
- Experience developing and executing global CMC regulatory strategies.
- Experience leading major submissions and Health Authority interactions.
- Experience driving organizational change and process improvements.
- Demonstrated leadership in global matrix organizations.
- Comprehensive knowledge of FDA, EMA, Health Canada, ICH, and global CMC requirements.
- Advanced strategic thinking and regulatory risk-assessment skills.
- Exceptional communication, negotiation, and leadership skills.
- Ability to influence senior leaders and governance committees.
- Strong organizational and resource-planning capabilities.
- Proven ability to build and develop high-performing teams.
- Knowledge of digital regulatory trends, structured content, data governance, and AI applications.
- Ability to establish governance and controls for AI-enabled regulatory processes.
- Experience leveraging AI-enabled tools for dossier preparation, content development, review, and knowledge management.
- Ability to evaluate and oversee AI-generated regulatory content.
- Commitment to innovation, continuous improvement, and operational excellence.
Nice To Haves
- Advanced degree (M.S., Pharm.D., or Ph.D.).
- Experience implementing technology-enabled process improvements in regulated environments.
Responsibilities
- Lead development and execution of global CMC regulatory strategies for multiple investigational and marketed products in the small-molecule portfolio.
- 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 abreast of and adopt emerging technologies, including AI, and maintain a continuous learning mindset to strengthen regulatory CMC decision-making and innovation.
- Remain up to date on advances in technology, AI, automation, competitive intelligence, and changes in the regulatory environment.
Benefits
- Annual bonus and annual equity awards.
- Medical, dental, and vision benefits.
- Generous paid time off, including a week-long company shutdown in the summer and winter.
- Educational assistance programs, including student loan repayment.
- Commuting subsidy.
- Matching charitable donations.
- 401(k).
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What This Job Offers
Job Type
Full-time
Career Level
Director
