Manager, Regulatory CMC

Legend Biotech is seeking a Manager, 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 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. 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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