Senior Director, Regulatory Affairs

Role: Senior Director of Regulatory Strategy & Registration responsible for developing and executing global regulatory strategies for neuroscience and rare disease programs from IND/CTA through NDA/BLA. Responsibilities: serve as primary regulatory liaison with health authorities (FDA, EMA, MHRA), lead expedited designation pursuits (Breakthrough, Fast Track, RMAT, Orphan Drug), oversee regulatory submissions, author strategy documents, and ensure compliance; provide leadership and mentorship within regulatory functions; support regulatory aspects of business development and governance. Requirements: advanced degree in a scientific or medical field (PhD, MD, PharmD, MS), 15+ years of progressive regulatory affairs experience in biotech/pharma, proven success in global regulatory strategy, health authority interactions, and expedited pathways; strong knowledge of ICH, GCP, and global regulations; excellent communication and strategic skills. HighValue: neuroscience/psychiatry, rare disease, global development, IND to BLA, expedited pathways, regulatory leadership, experience with regulatory information management systems (e.g., Veeva, KIVO). WorkSetup: hybrid (Mountain View, CA preferred), remote considered; occasional travel for health authority meetings and team engagements.