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 Hybrid in RTP. The Associate Director, Regulatory CMC is a key member of the regulatory organization responsible for developing and executing global CMC strategies for gene therapy programs. This role collaborates cross-functionally to deliver high-quality submissions, including INDs, BLAs, and MAAs, while ensuring alignment with regulatory expectations and timelines. The individual provides expert CMC guidance, authors and coordinates Module 3 content, manages health authority requests, supports regulatory meetings, and evaluates change controls and program risks. Candidates should have a bachelor’s degree (advanced preferred) and 5+ years of Regulatory CMC experience supporting gene therapies, biologics, or ATMPs, with strong knowledge of FDA requirements. Excellent communication, project leadership, and influencing skills are essential.