Director of Regulatory Affairs

Role: Regulatory Affairs Director overseeing global regulatory strategies and submissions, including the upcoming NDA filing. Responsibilities: manage and execute high-quality regulatory submissions, perform detailed document review and quality control, maintain regulatory records, coordinate with cross-functional teams, develop and support regulatory strategies for clinical and manufacturing programs, contribute to labeling and inspection readiness, and oversee external vendors. Requirements: Bachelor's in a scientific discipline with 8+ years in pharma/biotech, including 6+ years in Regulatory Affairs; hands-on experience with NDA/BLA/MAA submissions and electronic submissions (eCTD); deep knowledge of FDA and ICH regulations; familiarity with GMP, GCP, GLP; experience supporting regulatory interactions and working with CROs/CMOs. Preferred: advanced degree (MS, PhD, PharmD), RAC certification, experience in metabolic/endocrine/cardiometabolic areas, drug-device combination products, and knowledge of digital publishing tools. High-Value: NDA filing, regulatory strategy, eCTD, cross-functional collaboration, global regulatory standards, small to mid-size sponsor environment, and remote working at San Diego headquarters.