Sr Director, Regulatory Affairs

Role: Senior Director of Regulatory Affairs supporting late-stage biopharma development, focusing on biologics for rare metabolic and endocrine disorders, including hyperinsulinism and tumor-related hyperinsulinism. Responsibilities: develop and execute regulatory strategies across clinical, CMC, and commercial areas; lead agency interactions for IND, BLA submissions, and expedited pathways; advise on global regulatory requirements; ensure compliance and risk mitigation; support business development and investor relations. Qualifications: BS/MS with 15+ years in biopharma regulatory affairs, deep expertise in biologics, experience with BLA approvals, and knowledge of rare disease, endocrinology, and oncology programs. Preferred: successful global strategy implementation, experience with health authority interactions, and CMC lifecycle management. HighValue: biologics development in rare diseases, late-stage approval, FDA interactions, BLA submission, orphan/fast-track designations, global regulatory strategy, and cross-functional leadership. WorkSetup: not specified.