Director, Regulatory CMC

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.

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.

Legend Biotech is seeking a Director Regulatory CMC as part of the Regulatory Affairs team based in Somerset NJ.

Key Responsibilities

• 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.
• 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.
• 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.
• Lead and coordinate regulatory CMC planning preparation of submissions and interaction with Health Authorities.
• Establish and maintain strong partnerships with internal stakeholders and external collaborators to ensure effective execution of regulatory objectives.
• 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.
• Guide and support junior staff as applicable.

Requirements

• Advanced degree in life sciences biotechnology pharmaceutical sciences engineering or related discipline.
• 10 years of biotechnology or pharmaceutical industry experience.
• 7 years of Regulatory CMC experience supporting biologics cell and gene therapy. Direct experience with CAR-T cell therapies is desired.
• Strong CMC technical background is required. Ability to critically evaluate data from a broad range of scientific disciplines.
• 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.
• Demonstrated global CMC regulatory experience.
• Deep understanding of global CMC requirements on cell and gene therapy.
• Expertise in late-stage development and lifecycle management.
• Strong leadership strategic thinking communication and technical writing skills.
• Ability to manage multiple programs.

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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

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.

EEO Statement

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.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.