Director, Regulatory Affairs CMC

Role: Serve as Director, Regulatory CMC to develop and execute global regulatory strategies for small molecule therapeutics from development through commercialization. Responsibilities: lead CMC regulatory activities for marketed and in-development products, coordinate with R&D, manufacturing, and quality teams to develop submission strategies, prepare high-quality CMC sections for INDs, CTAs, NDAs, MAAs, and amendments, and manage communications with regulatory agencies worldwide. Provide guidance on regulatory compliance, evaluate manufacturing changes, and stay current on guidelines. Requirements: Bachelor’s degree in life sciences or equivalent, 10+ years in CMC Regulatory Affairs with at least 5 years in management, deep knowledge of global CMC regulations, experience in preparing submission documents across phases, strong cross-functional collaboration, and international travel readiness. HighValue: Small molecule drugs, development to post-market stages, global regulatory strategy, IND/CTA/NDA/MAA submissions, lifecycle management, and cross-regional coordination. WorkSetup: Hybrid (San Diego, San Francisco, or Princeton); travel as needed.