Director, Regulatory Affairs

<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>Director, Regulatory Affairs</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-family: arial, helvetica, sans-serif; font-size: 12pt;">The Director of Regulatory Affairs is responsible for independently developing, coordinating and executing the global regulatory strategies. The Director will represent Regulatory Affairs on global cross-functional teams and provide oversight on regulatory strategy implementation for the assets. The Director will interact with health authorities to seek feedback and reach alignment on regulatory strategies; oversee activities for regulatory filings and ensure timely and high-quality submissions. The Director will also work closely with collaboration partner on a key asset.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Key Responsibilities</strong></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Responsible to independently develop innovative, robust global regulatory strategies and ensure their efficient and effective execution for Legend pipeline programs.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Lead the team efforts required for the submission of INDs, CTAs, and BLAs as well as related supplements/variations; ensure timely and high-quality submissions.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Lead the effort to evaluate the need to develop in-vitro diagnostic test or companion diagnostic tests for pipeline programs as needed.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Oversee the maintenance of INDs, CTAs and BLAs, and ex-U.S. filings as required.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Interface with the FDA and other health authorities to seek feedback and alignment on pre-clinical and clinical development strategies.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Serves as regulatory representative in global cross-functional development teams for pipeline programs; work closely with other line functions to ensure efficient execution of regulatory strategies.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Serve as regulatory representative in internal cross-functional teams for activities such as SOP development, business process improvements, etc.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Represent Legend regulatory affairs in external collaborations.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Serve as the regulatory affairs reviewer in the promotional material review committee.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Coach and mentor junior members in their roles on global project teams.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Have a good understanding of the competitive regulatory landscape in oncology, immunology and cel