Associate Director/Director, CMC Regulatory
Relay Therapeutics · Cambridge, MA
RegulatoryCompany career page
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Role summary
Relay Therapeutics seeks an experienced CMC regulatory professional to lead chemistry, manufacturing, and control strategy development and execution for investigational and commercial pharmaceutical programs. This role requires independent management of global regulatory submissions and cross-functional coordination with minimal supervision.
What they're looking for
- 8-10+ years CMC-regulatory affairs experience, preferably solid oral small molecules
- Bachelor's or advanced degree in Pharmaceutical Sciences, Chemistry, or related field
- In-depth knowledge of FDA, EMA, ICH global CMC regulatory requirements and guidelines
- Demonstrated ability to lead regulatory projects independently with sound judgment
- Strong technical writing and document review capabilities
- Excellent organizational skills and ability to manage multiple competing priorities
What you'll be doing
- Develop and execute CMC regulatory strategies and global submission plans for assigned development programs
- Define CMC content requirements for regulatory submissions and ensure compliance with established standards
- Lead coordination of responses to regulatory authority CMC questions and requests for information
- Manage CMC regulatory assessments on compliance topics including change controls and GMP investigations
- Communicate CMC regulatory strategies, risks, and key issues to cross-functional teams and management
Privacy & handoff
This role links to Relay Therapeutics's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.