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Director or Senior Director, Regulatory CMC

Kymera Therapeutics
August 21, 2026
Full-time
Remote friendly (Greater Boston)
Worldwide
Other
Role: Lead global regulatory CMC strategy for Kymera's targeted protein degradation (TPD) small molecule programs across all development stages, with a focus on late-stage activities. Responsibilities: develop and execute regulatory CMC plans, author and review submission content (INDs, CTAs, NDA/MAA), advise leadership on regulatory strategies and health authority interactions, oversee compliance of external manufacturing/testing partners, and monitor evolving global CMC guidance. Requirements: BS/MS/PhD in Chemistry, Pharmaceutics, or related field; 10+ years in biotech/pharma regulatory CMC, with substantial experience in late-stage (pivotal trials through post-approval) activities for small molecules. HighValue: expertise in small molecule drug substance and product development, lifecycle management, analytical methods, and global regulatory requirements (FDA, EMA, ICH). Senior leadership role involving cross-functional collaboration with CMC, Quality, Non-Clinical, and Clinical teams. WorkSetup: not specified; likely hybrid or onsite depending on organizational needs.