About the position
Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. 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.
Responsibilities
• Support the development and execution of global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and lentiviral vector products.
• Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to plan, prepare, review, and coordinate CMC components of global regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments, supplements, and responses to Health Authority requests.
• Author, review, and maintain high-quality CMC regulatory documentation to support global development, registration, and commercialization activities, ensuring compliance with applicable regulatory 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 translate it into clear, scientifically sound regulatory submissions.
• Evaluate and interpret technical documentation, including development reports, validation protocols and reports, comparability assessments, and manufacturing change packages, to support regulatory impact assessments, submission strategies, and regulatory decision-making.
Requirements
• Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biochemistry, Chemistry, Engineering, or related discipline required.
• 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.
• 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.
Nice-to-haves
• Advanced degree (MS, PhD, PharmD) preferred.
• Experience supporting cell and gene therapies highly preferred.
Benefits
• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight (8) weeks of paid parental leave after just three (3) months of employment
• Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• Voluntary commuter benefits
• Family planning and care resources
• Well-being initiatives
• Peer-to-peer recognition programs