Director, Regulatory CMC

About the role

Legend Biotech is a global biotechnology company focused on treating and ultimately curing life‑threatening diseases. Headquartered in Bridgewater, New Jersey, the company advances next‑generation cell therapies—including autologous, allogeneic, and in‑vivo approaches—across platforms such as CAR‑T, TCR‑T, and NK‑cell therapies. Legend Biotech is seeking a Director, Regulatory CMC to join the Regulatory Affairs team in Somerset, NJ.

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 a 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.
• Ability to critically evaluate data from a broad range of scientific disciplines.
• Demonstrated experience leading late‑stage programs and post‑approval Regulatory CMC activities for 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.

Pay

Base pay range: $193,629 – $254,137 USD. Additional compensation may include performance‑based bonus and/or equity for eligible roles.

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid time off policy that includes vacation, personal, sick time, floating holidays, and eleven 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.

Work Authorization

Applicants must be authorized to work in the United States. Legend Biotech participates in the E‑Verify program and will require completion of the Form I‑9 process for all new hires.