Director, Regulatory CMC
About The Position
Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. This role involves developing, leading, and executing global CMC regulatory strategies for commercial products and development-stage programs, with a primary focus on late-stage development and post-approval lifecycle management. The position requires providing strategic regulatory leadership to cross-functional teams, influencing development and manufacturing strategies, identifying regulatory risks and opportunities, and driving mitigation plans. The Director will serve as the primary Regulatory CMC representative on program teams and governance committees, ensuring alignment with corporate goals. Responsibilities also include leading regulatory CMC planning, preparing submissions, interacting with Health Authorities, and establishing strong partnerships with internal and external stakeholders. Additionally, the role involves driving continuous improvement initiatives within the Regulatory CMC function and guiding junior staff.
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.
Nice To Haves
- Direct experience with CAR-T cell therapies is desired.
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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
