Associate Director/Director, CMC Regulatory

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.

Responsibilities

• 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

Requirements

• 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