Director or Senior Director, Regulatory CMC

Kymera Therapeutics

Kymera Therapeutics seeks a Director or Senior Director of Regulatory CMC to lead global regulatory strategy for targeted protein degradation programs across development stages. The role encompasses CMC regulatory submissions, health authority interactions, and oversight of manufacturing partners for small molecule degrader therapeutics.

Responsibilities

Develop and execute global regulatory CMC strategies for degrader programs across all development stages
Serve as regulatory CMC lead for multiple programs, coordinating with CMC, Quality, and Clinical teams
Author, review, and approve CMC content for INDs, CTAs, NDA/MAA modules, and regulatory amendments
Prepare for and lead FDA, EMA, and global health authority interactions on CMC matters
Monitor and communicate evolving global CMC regulatory guidance to cross-functional teams

Requirements

BS, MS, or PhD in Chemistry, Pharmaceutics, Biochemistry, Chemical Engineering, or related discipline
10+ years progressive Regulatory Affairs CMC experience in biotech or pharma
Deep experience with late-stage regulatory CMC activities through NDA/MAA approval
Extensive hands-on small molecule CMC development and control strategy experience
Demonstrated success authoring and managing CMC content for IND/CTA and marketing applications
Ability to lead cross-functional teams and provide strategic regulatory guidance

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Vacancy posted 4 days ago

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