Manager, Project Management, Regulatory

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Manager, Regulatory Project Management as part of the Regulatory team based in Somerset, NJ.  Role Overview This role will be reporting to the Director of Project Management Regulatory. We are seeking a motivated, detail-oriented Project Manager to support the planning and execution of Cell & Gene Therapy development programs. Working closely with cross-functional teams, this individual will coordinate project activities, monitor timelines, facilitate effective communication, and provide administrative support to ensure projects are executed efficiently and meet key development milestones. This opportunity is well suited to an individual with early-career project management experience in the biotechnology or pharmaceutical industry who is eager to grow in a fast-paced, collaborative environment. The successful candidate will play a key role in project coordination, documentation, meeting management, and operational support throughout the product development lifecycle. Key Responsibilities Coordinate day-to-day project activities across cross-functional teams, including Research, CMC, Quality, Regulatory Affairs, Clinical Operations, and external partners. Develop and maintain project timelines, action-item trackers, meeting agendas, and other key project documentation. Schedule and facilitate project team meetings, prepare meeting minutes, and follow up on action items to support timely completion. Monitor project progress and promptly escalate potential risks, delays, and resource constraints to project leadership. Support the preparation and coordination of activities related to Investigational New Drug (IND) submissions and other regulatory filings. Track project budgets, purchase orders, invoices, and resource utilization in collaboration with Finance and functional leads. Assist with preparation of project dashboards, presentations, reports, and materials for leadership reviews, governance meetings, and investor or partner updates. Assist with onboarding n...