Associate Director, CMC Regulatory Affairs - Small Molecules

Role: Associate Director, CMC Regulatory Affairs, providing strategic and operational leadership for regulatory activities related to small molecule drug products, primarily oral solid dosage forms, from development through commercialization. Responsibilities: develop and execute global CMC regulatory strategies; lead regulatory submissions (INDs, NDAs, MAAs, amendments); serve as primary regulatory liaison for CMC topics; support manufacturing, formulation, analytical, and lifecycle management activities; ensure compliance with global agencies including FDA, EMA, GCC, and PMDA; and lead health authority interactions. Requirements: Bachelor's in pharmaceutical sciences, chemistry, or related field; 8+ years in pharmaceutical/biotech regulatory affairs with significant CMC expertise; experience supporting small molecule products from IND to post-approval; strong knowledge of global regulatory requirements and submission processes. Preferred: advanced degrees (MS, PhD, PharmD), experience with lifecycle management of oral solid dosage forms, and familiarity with biologics or combination products. High-Value: focus on small molecule oral solid drugs, global regulatory submissions, lifecycle management, cross-functional collaboration, and experience with major international regulatory agencies. Work Setup: remote with some travel (~10%), onsite presence required in San Diego, face-to-face interactions essential.