Associate Director, CMC Regulatory Affairs - Small Molecules

Role: Associate Director, CMC Regulatory Affairs responsible for strategic and operational leadership of CMC activities supporting small molecule drug development and commercialization, primarily oral solid dosage forms. Responsibilities: develop and execute global CMC regulatory strategies, lead submissions (INDs, NDAs, amendments, variations), liaise with health authorities (FDA, EMA, PMDA, GCC), and support lifecycle management including manufacturing changes and site transfers. Collaborate closely with Pharmaceutical Development, Manufacturing, Quality, Regulatory Operations, and Supply Chain teams to ensure compliance, alignment, and timely submissions. Provide technical regulatory guidance on formulation development, process validation, process transfer, analytical methods, and post-approval changes. Qualifications: Bachelor's in Pharmaceutical Sciences, Chemistry, or related field; 8+ years in pharmaceutical regulatory affairs with extensive CMC experience supporting small molecules from IND through post-market. Preferred: advanced degree (MS, PhD, PharmD). High-value: expertise in oral solid dosage drug products, global regulatory submissions, lifecycle management, and interactions with global health authorities. Work setup: Remote in San Diego, with approximately 10% travel domestically and internationally.