Director, Global CMC Regulatory Strategy & AI Enablement

Vertex Pharmaceuticals Inc (US)

Boston (MA)

Hybrid

USD 190,400 - 285,600

Full time

14 days+

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Benefits offered by this job

Annual bonus

Equity awards

401(k)

Commuting subsidy

Paid time off (PTO)

Educational assistance

Job summary

Vertex Pharmaceuticals Inc is seeking a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies and submissions across small molecule programs. The role emphasizes strategic leadership, Health Authority engagement, and integration of regulatory requirements into development and commercialization plans.

The ideal candidate will have 10+ years in pharma/biotech, strong leadership, and a track record of major submissions, with a

Qualifications

Bachelor’s degree in Chemistry, Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences, Engineering, or related life sciences discipline.
Advanced degree (M.S., Pharm.D., or Ph.D.) preferred.
10+ years of pharmaceutical/biotechnology experience supporting small molecule development.
3+ years of people management leading technical/regulatory professionals.
Experience developing and executing global CMC regulatory strategies.
Experience leading major submissions and Health Authority interactions.
Commitment to innovation, continuous improvement, and operational excellence.
Budgetary and direct people-management accountability may apply.

Responsibilities

Leads development and execution of global CMC regulatory strategies for multiple investigational and marketed products in the small molecule portfolio.
Oversees preparation, review, and approval of CMC content for global regulatory submissions.
Provides strategic leadership for Health Authority interactions and negotiations.
Leads and develops Regulatory CMC staff through coaching and talent development.
Ensures consistent regulatory guidance to cross-functional stakeholders.
Serves as senior Regulatory CMC representative on governance bodies and product teams.
Identifies regulatory risks and develops mitigation strategies.
Drives continuous improvement through structured content and digital regulatory capabilities.
Champions AI-enabled technologies for authoring, review, data traceability, and knowledge management.
Ensures programs are appropriately resourced and accountable for regulatory milestones.
Stays abreast of and adopts emerging technologies, including AI, and maintains a continuous learning mindset to strengthen regulatory CMC's decision-making and innovation.