Sr. Manager, Regulatory CMC

<div class="content-intro"><p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.</span></p></div><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech is seeking a <strong>Sr. Manager, Regulatory CMC</strong> as part of the <strong>Regulatory Affairs</strong> team based in <strong>Somerset, NJ. </strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Role Overview</strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">This position will support the development and execution of global CMC regulatory strategies for pipeline programs, with a strong focus on regulatory dossier authoring and cross-functional collaboration to advance product development milestones.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Key Responsibilities</strong></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Support the development and execution of global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and lentiviral vector products.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to plan, prepare, review, and coordinate CMC components of global regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments, supplements, and responses to Health Authority requests.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Author, review, and maintain high-quality CMC regulatory documentation to support global development, registration, and commercialization activities, ensuring compliance with applicable regulatory requirements and company standards.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Collaborate with cross-functional technical teams, including Process Development, Manufacturing,</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Analytical Development, and Quality, to understand complex CMC information and effectively translate it into clear, scientifically sound regulatory submissions.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Evaluate and interpret technical documentation, including development reports, validation protocols and reports, comparability assessments, and manufacturing change packages, to support regulatory impact assessments, submission strategies, and regulatory decision-making.</span></li> </ul> <p> </p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Requirements</strong></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biochemistry, Chemistry, Engineering, or related discipline required. Advanced degree (MS, PhD, PharmD) preferred.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">5+ years of biotechnology or pharmaceutical industry experience with strong technical background.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Minimum of 1-2 years of Regulatory CMC experience supporting biologics, cell and gene therapy products, or extensive experience authoring and managing CMC sections of regulatory dossiers and submissions.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-