Director, Regulatory Affairs

Role: Director, Regulatory Affairs at Legend Biotech, leading global regulatory strategies for cell therapy products, including CAR-T and other immunotherapies, in collaboration with J&J. Responsibilities: independently develop and execute regulatory plans for pipeline programs; oversee IND, CTA, BLA submissions and maintenance; interact with health authorities to align on development strategies; represent Regulatory Affairs in cross-functional teams; evaluate need for companion diagnostics; mentor junior staff; monitor competitive regulatory landscape. Requirements: PharmD, PhD, or equivalent; 7+ years in regulatory affairs with experience in biologics, cell and gene therapies, and global submissions; strong knowledge of IND/CTA/BLA/MAA processes; ability to lead strategic initiatives and develop innovative regulatory pathways; excellent communication and organizational skills. Preferred: experience in multiple myeloma or drug development in oncology; familiarity with CDx development and GxP regulations. High-Value: biologics, cell/gene therapies, oncology indications, global regulatory environment, IND/CTA/BLA filings, collaboration with external partners. WorkSetup: based in Somerset, NJ.