Manager, Regulatory Affairs

Role: Regulatory Affairs Manager supporting late-stage clinical development of gene therapy products, primarily in CNS disorders, at Neurogene. Responsibilities: develop and execute regulatory strategies, prepare and submit INDs/CTAs and other regulatory documents, review clinical protocols and materials, manage interactions with authorities, ensure compliance with FDA/ICH guidelines, and monitor evolving regulatory landscapes, including cell and gene therapy specifics like long-term follow-up and pharmacovigilance. Requirements: BS/MS/PhD in a scientific discipline; 3-7 years in regulatory affairs within biotech, with preference for biologics or gene therapy experience; knowledge of GCP, GMP, GLP, FDA/ICH standards; proficiency with regulatory tools like Veeva Vault RIM; strong communication, organizational, and project management skills; RAPS certification preferred. HighValue: gene therapy, CNS indications, regulatory submissions (INDs/CTAs), biologics, GMP compliance, late-stage clinical development. WorkSetup: New York City or remote; role involves cross-functional collaboration, with an emphasis on strategic regulatory planning and compliance.