Director, Regulatory Affairs CMC

Role: Lead global regulatory CMC strategy for small molecule therapies from development through commercialization, supporting clinical trials and marketing approvals worldwide. Responsibilities: develop and execute CMC regulatory plans, manage regulatory submissions (INDs, NDAs, MAAs), coordinate cross-functionally across R&D, manufacturing, and quality teams, act as primary regulatory contact with agencies, and ensure compliance with global guidelines. Qualifications: Bachelor’s in life sciences, 10+ years in CMC regulatory affairs for small molecules, including 5+ years in management; expertise in preparing regulatory submissions, knowledge of global CMC requirements, and experience with regulatory agency interactions. HighValue: small molecule drugs, global filings (US, ex-US including GCC, LATAM, APAC), clinical development, lifecycle management, cross-functional leadership, travel required. WorkSetup: hybrid (San Diego, San Francisco, or Princeton), 3 days/week onsite, with domestic and international travel.