Director, Regulatory Affairs CMC

Role: Director, Regulatory CMC responsible for developing and executing global regulatory strategies for small molecule therapies from development through commercialization, impacting markets including US, GCC, LATAM, and APAC. Responsibilities: manage CMC regulatory activities for marketed and in-development products, prepare regulatory submissions (INDs, CTAs, NDAs, MAAs), serve as a regulatory expert in cross-functional teams, and liaise with authorities. Ensure compliance and evaluate manufacturing changes for regulatory implications. Requirements: Bachelor’s in life sciences, 10+ years in CMC regulatory affairs focusing on small molecules, with at least 5 years in a management role; strong knowledge of global CMC regulations; experience with global submissions and agency interactions. Preferred: experience with regulatory filings for clinical trials and marketing applications, and familiarity with GxP guidelines. HighValue: small molecule development, global regulatory strategy, cross-regional submissions, and lifecycle management. WorkSetup: hybrid model in San Diego, San Francisco, or Princeton, requiring about three days in the office weekly; domestic and international travel as needed.