Associate Director, Regulatory Affairs

Role: Associate Director of Regulatory Affairs leading global regulatory strategy for gene therapy programs from early development through marketing authorization. Responsibilities: develop and execute regulatory plans, prepare submissions (including pre-IND, orphan/PIP, Scientific Advice, BLA/MAA), support global interactions, and guide commercialization activities with labeling and promotional guidance. Collaborate across R&D, Quality, Manufacturing, and regional teams in the US, EU, and Japan; represent the company externally. Requirements: bachelor's degree (advanced in biological sciences preferred); 6-8 years regulatory experience in biologics, orphan diseases, or CNS; proven success in product approval, complex issue resolution, and high-quality documentation. HighValue: gene therapy, biologics, orphan disease focus, global regulatory strategy, BLA/MAA submission, cross-functional leadership, international regulatory collaboration, up to 15% travel.