Senior RegCMC Lead, Global Small-Molecule Strategy (Waltham)
Full-time
Skyhawk Therapeutics
Skyhawk Therapeutics in Waltham, MA seeks an hands-on Associate Director, Regulatory Affairs CMC to lead global RegCMC strategy across small‑molecule programs from IND through NDA/MAA readiness. You will author CTD Module 3 content, coordinate with Development, Manufacturing, Quality, and Program teams, and ensure timely regulatory submissions to advance development and commercialization.
The role requires an advanced degree and 7+ years of RegAff CMC experience with global submissions; strong
#J-18808-LjbffrVacancy posted more than 2 months ago
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