Senior Director, Regulatory CMC

Role: Senior Director, Regulatory CMC overseeing global regulatory strategy and execution for small molecule development programs from preclinical to late-stage approval. Responsibilities: lead integrated CMC strategies, provide technical and strategic guidance across drug substance, drug product, analytical development, and manufacturing; manage external CDMOs and oversee regulatory submissions (INDs, NDAs, modifications); ensure compliance with FDA, EMA, ICH, and cGMP standards; monitor regulatory landscape; and collaborate across cross-functional teams to align development and regulatory plans. Requirements: Master's in Chemistry, Pharma Sciences, or related field; 12+ years pharma experience with at least 5 years in Regulatory CMC supporting small molecules, including late-stage development and NDA activities; proven experience authoring and managing regulatory filings; strong knowledge of drug development, manufacturing, and global regulatory requirements; demonstrated leadership in external partner management. Preferred: experience in orexin, CNS, or neuropsychiatric therapeutic areas. HighValue: small molecule development, late-stage regulatory filings (NDA), global CMC strategy, external manufacturing oversight, cGMP compliance, cross-functional leadership. WorkSetup: US-based, occasional travel.