Senior Manager, CMC Regulatory Affairs - Small Molecules

Role: Senior Manager, CMC Regulatory Affairs, leading strategic and operational regulatory activities for small molecule drug products, primarily oral solid dosage forms, from development through commercialization. Responsibilities: develop and execute CMC regulatory strategies; prepare and submit regulatory documentation (INDs, NDAs, supplements, variations); serve as the primary CMC regulatory representative on cross-functional teams; support lifecycle management, process validation, process changes, and technology transfers; liaise with regulatory authorities globally, including FDA and EMA; ensure compliance with GxP and quality standards; support inspection readiness and regulatory assessments. Qualifications: Bachelor's in Pharmaceutical Sciences, Chemistry, or related field; 7+ years in pharmaceutical/biotech regulatory affairs, with significant experience in small molecule CMC activities; demonstrated success in global regulatory submissions and lifecycle management. Preferred: advanced degree (MS, PhD, PharmD); experience with biologics or combination products advantageous; strong leadership and stakeholder management skills; travel approximately 10%, with onsite presence in San Diego preferred. High-Value: focus on oral solid dosage development, lifecycle management, global regulatory engagement, and cross-functional collaboration within a fast-paced, patient-centered environment.