Serves as the regulatory CMC representative on core teams, develops and plans regulatory CMC submission strategy with a focus on allogeneic gene-edited products. Provides guidance to technical team members for the requirements, especially on the unique requirements on gene editing technologies and allogeneic therapies. Identify the required documentation to support global submissions and coordinate the delivery of approved technical source documents in accordance with project timelines. Provide ... more details
Company Information
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 and natural killer (NK) cell-based immunotherapy.
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) in 2017. 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 an Associate Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ.
Key Responsibilities
Serves as the regulatory CMC representative on core teams, develops and plans regulatory CMC submission strategy with a focus on allogeneic gene-edited products.
Provides guidance to technical team members for the requirements, especially on the unique requirements on gene editing technologies and allogeneic therapies. Identify the required documentation to support global submissions and coordinate the delivery of approved technical source documents in accordance with project timelines.
Provide guidance on allogeneic and gene-edited product development at the R&D phase.
Coordinates and manages CMC regulatory submissions, applying CMC global regulatory strategies.
Prepare briefing books for Health Authority meetings.
Facilitate consistency within the CMC regulatory documentation by sharing experience and/or contributing to template maintenance.
Establish and maintain sound working relationships with partners and customers.
Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
Requirements
Advanced degree in life sciences
5-7 years of experience in biotechnology, analytics or pharmaceutical technology. Knowledge of the current gene editing and allogeneic technology is required. Ability to critically evaluate data from a broad range of scientific disciplines.
At least 2-3 years of experience in CMC regulatory affairs supporting early and late-stage allogeneic gene-edited product development.
Solid knowledge of regulatory submission procedures including CMC requirements for filing and maintaining INDs and IMPDs.
Proven track record to successfully support IND/IMPD filing and late stage allogeneic gene-edited product development.
Proven track record to successfully work in interdisciplinary teams, planning, and coordinating.
Effective planning, organizational and interpersonal skills.
Good technical writing skills.
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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
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