Director, Regulatory Affairs

Lead and execute regulatory strategies to support development of CAR T programs. Prepare, review, and submit INDs, amendments, and regulatory correspondence to FDA and other global health authorities. Serve as primary regulatory contact with health authorities, including FDA, EMA and other global agencies, representing BrainChild Bio in meetings and discussions. Collaborate cross-functionally with Clinical, CMC, Quality, and Patient Operations to ensure regulatory compliance and alignment with program objectives Identify risks and opportunities, providing strategic recommendations to accelerate development timelines. Advise on regulatory implications of protocols, manufacturing processes, and patient logistics. Manage regulatory timelines, submissions, and deliverables across multiple programs. Stay informed of emerging regulations, guidance documents, and industry trends specific to cell and gene therapy.