Senior Director, Regulatory CMC

Rapport Therapeutics · Boston, MA

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Role summary

Senior Director of Regulatory CMC role at a precision neuromedicine company developing small-molecule therapies. Combines strategic leadership with execution to develop CMC strategies, manage regulatory submissions globally, and build the regulatory function.

What they're looking for

Bachelor's degree in scientific discipline; advanced degree preferred
12+ years regulatory CMC experience in biotech or pharma with late-stage and global registration work
Deep understanding of CMC development, manufacturing, analytical, quality, and regulatory considerations
Experience developing global CMC strategies across multiple development stages
Led or supported CMC content for INDs, IMPDs, and marketing applications including CTD Module 3
Contributed to at least one NDA or MAA through submission and Health Authority review
Strong knowledge of FDA, EMA, ICH, and global CMC requirements and Health Authority interactions

What you'll be doing

Develop and execute global regulatory CMC strategies across development programs from early stage through commercialization
Lead cross-functional teams as Regulatory CMC lead, providing strategic guidance on CMC, manufacturing, analytical, quality, and lifecycle activities
Prepare, review, and coordinate CMC content and strategy for global regulatory submissions and applications
Support FDA, EMA, and global health authority interactions including meeting preparation and regulatory responses
Evaluate CMC changes and provide risk-based regulatory recommendations; build and develop the Regulatory CMC function

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Date posted2 days ago

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