Director, Regulatory Affairs

Role: Regulatory Affairs Director responsible for managing and executing global regulatory submissions, including preparing for an upcoming NDA filing, and supporting regulatory strategy development. Responsibilities: coordinate content development, quality review, and submission of INDs, NDAs, and lifecycle management; oversee regulatory document quality and compliance; maintain regulatory records and manage external publishing vendors; support health authority interactions and meetings; contribute to product labeling and regulatory risk assessments; ensure inspection readiness; and develop global regulatory strategies across CMC, nonclinical, and clinical areas. Requirements: Bachelor's in a scientific discipline; 8+ years in pharmaceutical/biotech industry with at least 6 years in Regulatory Affairs; hands-on experience with regulatory submissions, especially eCTD, and knowledge of FDA, ICH, GMP, GCP, and GLP regulations; experience supporting NDA/BLA/MAA filings; familiarity with small/mid-size sponsor operations, and therapeutic areas including metabolic, endocrine, or cardiometabolic. Preferred: advanced degree (MS, PhD, PharmD), RAC certification, experience with peptide therapeutics, drug-device combination products, and regulatory information systems. Work setup: on-site in San Diego, CA; no travel specified.