Senior Manager, Regulatory Strategy

<div class="content-intro"><p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p> <p style="line-height: 1.2;"> </p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p> <p style="line-height: 1.2;"> </p></div><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is seeking a <strong>Senior Manager, Regulatory Strategy </strong>as part of the <strong>Regulatory Affairs </strong>team based in <strong>Somerset, NJ</strong>.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Role Overview</strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">The Senior Manager, Regulatory Strategy will report to the Director of Regulatory Affairs  and provide support and potentially function as the RA lead of a project in defining and executing global regulatory strategies across the development lifecycle, from early development through registration and lifecycle management. This individual will serve as a strategic regulatory partner to cross-functional teams and help prepare, review and manage regulatory submissions.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><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;">Lead the preparation, submission, management and maintenance global regulatory submissions including IND / CTAs, amendments, information requests, Orphan Drug Applications, DSUR / IB, and Marketing Applications etc.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Coordinate and prepare for Agency meetings and meeting package preparation.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide strategic regulatory input on clinical development plans, CMC strategies, and nonclinical programs to support regulatory milestones.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Contribute to regulator ... (truncated, view full listing at source)