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Director Regulatory Affairs role with local small biotech - great opportunity to work with dedicated and collaborative team! Leading strategy and operations, for clinical and CMC aspects, interesting pipeline from early stage to marketed products!

 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.