Senior Manager, CMC Regulatory Affairs - Small Molecules

Role: Senior Manager, CMC Regulatory Affairs, provides strategic and operational leadership for Chemistry, Manufacturing, and Controls activities supporting small molecule drug development and commercialization, primarily oral solid dosage forms such as tablets and capsules. Responsibilities: develop and execute CMC regulatory strategies across development stages from IND through post-approval; lead regulatory submissions including INDs, NDAs, amendments, and lifecycle management activities; serve as the primary regulatory interface on cross-functional teams collaborating with Pharmaceutical Development, Manufacturing, Quality, and Regulatory Operations; assess regulatory risks and develop mitigation strategies; support regulatory inspections and responses; guide post-approval CMC change strategies. Requirements: Bachelor's degree in pharmaceutical sciences, chemistry, or related field; 7+ years in pharmaceutical/biotech regulatory affairs with substantial experience in small molecule CMC; proven track record supporting oral solid dosage form development, process validation, and lifecycle management; experience with global regulatory authorities (FDA, EMA, PMDA, GCC); strong leadership, strategic thinking, and cross-functional collaboration skills. High-Value: extensive experience in CMC submissions, lifecycle management, manufacturing process development, and global regulatory interactions; supporting small molecule oral dosage forms from IND to post-market phases; experience with regulatory strategies for manufacturing changes and technology transfers; ability to operate independently and lead complex projects. Work Setup: Remote-based in San Diego, with approximately 10% domestic and international travel; face-to-face collaboration expected as needed.