Crescent Biopharma is seeking a senior Regulatory Affairs CMC leader to oversee global submissions and ensure compliance across the product lifecycle. You will lead IND/MAA programs, negotiate with FDA/EMA, and guide TechOps and Quality to readiness for clinical and commercial supply.
The role requires 12+ years in CMC regulatory affairs, strong negotiation skills, and experience with biologics/ADC platforms. Leadership and strategic thinking are essential in a fast-paced environment.
#J-18808-LjbffrCMC Regulatory Affairs Executive Leader (Global) in waltham at Unknown Company
This position is listed as full time and onsite.