Strategic Director Global CMC Regulatory Affairs (Hybrid)

Vertex Pharmaceuticals LLC

Boston (MA)

Hybrid

USD 190,400 - 285,600

Full time

14 days+

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Benefits offered by this job

Hybrid work arrangement

On-site option

Annual bonus

Equity awards

Job summary

Vertex Pharmaceuticals LLC is seeking a Director of Regulatory Affairs CMC in Boston. The role leads a Regulatory CMC team, shaping global strategies for small molecule programs and coordinating Health Authority interactions across development and commercialization.

Hybrid work options are available, with emphasis on strategic leadership and digital regulatory capabilities. The candidate will guide dossier preparation, drive process improvements, and foster cross-functional collaboration in a

Qualifications

Bachelor's degree in chemistry, biology, regulatory affairs, pharmaceutical sciences, engineering, or related life sciences.
Advanced degree (M.S., Pharm.D., or Ph.D.) preferred.
10+ years of pharmaceutical/biotech experience in small molecule development.
3+ years of people management experience leading regulatory professionals.
Experience developing global CMC regulatory strategies and major submissions.

Responsibilities

Lead global CMC regulatory strategies for multiple products (investigational and marketed).
Oversee preparation, review, and approval of CMC content for global submissions.
Provide strategic leadership for Health Authority interactions and negotiations.
Develop and coach Regulatory CMC staff; drive cross-functional alignment.
Champion AI-enabled technologies for regulatory content authoring and knowledge management.