Director, Regulatory CMC

Role: Director, Regulatory CMC at Legend Biotech, leading global regulatory strategies for cell therapy products, especially late-stage biologics and gene therapies like CAR-T. Responsibilities include developing and executing CMC regulatory plans, supporting lifecycle management, and engaging with health authorities. Serves as the primary CMC representative in cross-functional teams, driving submission preparations and compliance initiatives. Requirements: advanced life sciences degree; 10+ years industry experience with 7+ years in Regulatory CMC supporting biologics and cell/gene therapies; expertise in late-stage development, lifecycle management, and global CMC regulations, particularly for cell and gene therapies including CAR-T. Preferred: direct CAR-T experience. Skills include strong technical evaluation, leadership, strategic planning, and communication. High-value: biologics/cell/gene therapy, CAR-T, late-stage development, post-approval lifecycle support, global regulatory expertise. Work setup: based in Somerset, NJ; specifics on remote or travel not provided.