Manager, 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 aManager Regulatory CMC as part of the Regulatory Affairs team based in Somerset NJ.

Role Overview

This position will support the development and execution of global CMC regulatory strategies for pipeline programs with a strong focus on regulatory dossier authoring and cross-functional collaboration to advance product development milestones.

Key Responsibilities

• Support the development and execution of global CMC regulatory strategies for pipeline cell and genetherapy programs including CAR-T and lentiviral vector products.
• Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts toplan prepare review and coordinate CMC components of global regulatory submissions includingINDs CTAs BLAs MAAs amendments supplements and responses to Health Authority requests.
• Author review and maintain high-quality CMC regulatory documentation to support globaldevelopment registration and commercialization activities ensuring compliance with applicableregulatory requirements and company standards.
• Collaborate with cross-functional technical teams including Process Development Manufacturing
• Analytical Development and Quality to understand complex CMC information and effectively translateit into clear scientifically sound regulatory submissions.
• Evaluate and interpret technical documentation including development reports validation protocols andreports comparability assessments and manufacturing change packages to support regulatory impactassessments submission strategies and regulatory decision-making.

Requirements

• Bachelors degree in Life Sciences Biotechnology Pharmaceutical Sciences Biochemistry Chemistry Engineering or related discipline required. Advanced degree (MS PhD PharmD) preferred.
• 5 years of biotechnology or pharmaceutical industry experience with strong technical background.
• Minimum of 1-2 years of Regulatory CMC experience supporting biologics cell and gene therapy products or extensive experience authoring and managing CMC sections of regulatory dossiers and submissions.
• Experience working with process development analytical development or manufacturing teams.
• Experience supporting cell and gene therapies highly preferred.
• Familiarity with global regulatory requirements including FDA EMA and ICH guidelines.
• Strong scientific understanding and technical background on biologics or cell and gene therapy products.
• Excellent technical writing and document preparation skills with demonstrated experience authoring regulatory submission content.
• Ability to critically review and interpret scientific and technical data and translate complex information into clear regulatory documentation.
• Strong project management and organizational skills.
• Ability to manage multiple programs and competing priorities in a fast-paced environment.
• Strong communication and collaboration skills with cross-functional stakeholders.

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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.