Director, Regulatory CMC at Legend Biotech

<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 &amp; 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 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>Key Responsibilities</strong></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Develop, lead, and execute global CMC regulatory strategies across commercial products and development- stage programs, with primary accountability for late-stage development and post-approval lifecycle management activities.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide strategic regulatory leadership to cross-functional teams, influencing development and manufacturing strategies, identifying regulatory risks and opportunities, and driving effective mitigation and contingency plans to support program objectives.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Serve as the primary Regulatory CMC representative on cross-functional program teams and governance committees, ensuring alignment of regulatory strategies with corporate and portfolio goals.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead and coordinate regulatory CMC planning, preparation of submissions, and interaction with Health Authorities.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Establish and maintain strong partnerships with internal stakeholders and external collaborators to ensure effective execution of regulatory objectives.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Drive continuous improvement initiatives within the Regulatory CMC function, including development of regulatory processes, best practices, and knowledge management to enhance organizational effectiveness and compliance.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Guide and support junior staff as applicable.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Requirements</strong></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Advanced degree in life sciences, biotechnology, pharmaceutical sciences, engineering, or related discipline.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">10+ years of biotechnology or pharmaceutical industry experience.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">7+ years of Regulatory CMC experience supporting biologics, cell and gene therapy. Direct experience with CAR-T cell therapies is desired.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong CMC technical background is required. Ability to critically evaluate data from a broad range of scientific disciplines.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Demonstrated experience leading late-stage programs and post-approval Regulatory CMC experience supporting commercial products, including lifecycle management, supplements, variations, annual reports, and post-approval commitments.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Demonstrated global CMC regulatory experience.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Deep understanding of global CMC requirements on cell and gene therapy.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Expertise in late-stage development and lifecycle management.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong leadership, strategic thinking, communication, and technical writing skills.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to manage multiple programs.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-AS1</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-Hybrid</span></p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.</p> <p>Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.</p> <p>Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&amp;D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.</p></div><div class="title">Pay Range (Base Pay): </div><div class="pay-range"><span>$193,629</span><span class="divider">&mdash;</span><span>$254,137 USD</span></div></div></div><div class="content-conclusion"><p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><strong>Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.</strong></span></p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"><strong>Work Authorization &amp; Employment Eligibility</strong></span></p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.</span></p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>EEO Statement</strong></span></p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.</span></p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.</span></p> <div><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">For information related to our privacy notice, please review:&nbsp;<a href="https://legendbiotech.com/privacy-notice/" target="_blank">Legend Biotech Privacy Notice</a>.</span></div></div>