Director, Global Head of Regulatory Affairs

Role: Lead global regulatory strategy for innovative cell therapy pipeline, guiding development from IND through BLA submission and commercialization. Responsibilities: develop and execute regulatory strategies; manage interactions with FDA, EMA, and other authorities; oversee regulatory submissions including INDs, amendments, and future marketing applications; interpret regulatory feedback and ensure compliance; provide guidance to Clinical Development, CMC, and Quality teams; assess regulatory risks and build a high-performing regulatory organization. Qualifications: advanced degree (PhD, PharmD, MD, MS); 15+ years in biotechnology or pharmaceutical regulatory affairs; extensive experience with FDA interactions and successful submissions (NDA, BLA, MAA); strong knowledge of biologics, cell and gene therapy, oncology, immunology, or rare diseases; proven leadership and cross-functional collaboration skills. High-Value: biologics/cell therapy, IND-to-BLA development, FDA/Biologics licensing, multi-center clinical trials, regulatory strategy, biologics, gene/cell therapy, oncology, rare diseases. WorkSetup: hybrid Los Angeles; location may involve some travel.