Director, Regulatory Affairs

Leading the development and implementation of CMC regulatory strategy for small molecule investigational drugs, the full-time remote Director of CMC Regulatory Affairs will manage regulatory submissions, provide strategic advice, and ensure compliance with global regulatory requirements for clinical trials and marketing applications. Key responsibilities Develop and implement CMC regulatory strategies for global Phase 1-3 clinical trials and marketing applications Deliver high-quality regulatory submissions and manage internal and external contributors for investigational stage CMC documents Assess and identify risk mitigation plans based on evolving US and Ex-US GMP regulations and guidance Required qualifications BA/BS, MS, or PhD in a relevant technical discipline with 8+ years of CMC regulatory experience Deep technical knowledge of small molecule drug development and extensive command of worldwide CMC regulatory standards Experience in authoring high-quality INDs, IND amendments, and NDAs with a proven track record of meeting timelines Understanding of US and ex-US regulations, providing strategic advice, and supporting cross-functional teams RAC certification preferred