About this opportunity
Crescent Biopharma lists this CMC Regulatory Affairs Executive Leader (Global) opportunity in waltham, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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Worksite address
waltham, MA, 02254, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.