Manager, Regulatory CMC

Role: Manager, Regulatory CMC within Legend Biotech's Regulatory Affairs team, focusing on global CMC regulatory strategies for cell and gene therapy programs, including CAR-T and lentiviral products. Responsibilities: develop and execute CMC regulatory strategies, author and review regulatory documents supporting INDs, CTAs, BLAs, MAAs, and amendments; collaborate with cross-functional teams (Process Development, Manufacturing, Analytical Development, Quality) to ensure compliance and clarity of technical data for submissions; evaluate technical documentation for regulatory impact and decision-making. Requirements: Bachelor's in Life Sciences or related field; 5+ years in biotech/pharma, with 1-2+ years specifically in Regulatory CMC supporting biologics or cell & gene therapies; experience in authoring regulatory dossiers, understanding of global regulatory guidelines (FDA, EMA, ICH); strong scientific, technical writing, and project management skills. Preferred: advanced degrees (MS, PhD, PharmD), experience with cell/gene therapy products, and familiarity with process/analytical development. High-Value: biologics, cell and gene therapy, regulatory submissions, cross-functional collaboration, global compliance. Work setup: based in Somerset, NJ, with responsibilities supporting development, registration, and commercialization activities.