Head of Regulatory Affairs

Role: Lead global Regulatory Affairs for biopharma cell therapy pipeline, guiding development from IND to BLA submission and commercialization. Responsibilities: develop and implement regulatory strategies, manage interactions with FDA, EMA, and other authorities; oversee regulatory submissions including INDs and amendments; interpret regulatory policies; advise Clinical Development, CMC, and Quality teams; assess regulatory risks; build and lead the regulatory organization. Qualifications: 15+ years in biotech/pharma regulatory affairs; advanced degree (PhD, PharmD, MD, MS); extensive experience with FDA interactions, submissions, and successful marketing applications; strong knowledge of biologics, cell and gene therapies, oncology, immunology, or rare diseases. HighValue: biologics, cell/gene therapy, oncology, immunology, rare diseases, IND through BLA stages, FDA/EMA engagement, regulatory strategy leadership. WorkSetup: hybrid Los Angeles; global scope.