Director, Regulatory Affairs CMC

Role: Director of Regulatory Affairs CMC focusing on gene therapy for rare CNS diseases, supporting development and commercialization strategies. Responsibilities: provide CMC regulatory input across teams, lead global regulatory plans, contribute to submission strategies (INDs, BLAs, MAAs), support health authority interactions, and ensure compliance with evolving regulations in gene therapy and biologics. Requirements: Bachelor's in life sciences; 10+ years in Regulatory Affairs CMC, with 5+ years specializing in gene therapy, viral vectors, or biologics; BLA experience; proven record of leading global submissions for advanced therapies; solid understanding of biologics manufacturing, characterization, and analytical development. Preferred: advanced degree in Molecular Biology, Biochemistry, or Pharmaceutical Sciences. HighValue: extensive experience with biologics and gene therapy regulations (FDA CBER, EMA ATMP, ICH Q-series), viral vector technologies (AAV, lentivirus), and global health authority interactions. WorkSetup: based in New York, Houston, or remote; travel to Houston required.