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 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 knowledge of digital publishing tools High-Value NDA filing regulatory strategy eCTD cross-functional collaboration global regulatory standards small to mid-size sponsor environment remote working at San Diego headquarters #J-18808-Ljbffr Scorpion Therapeutics