Director, Regulatory CMC

Legend Biotech USA; New Jersey; On-site; USD 180,000 - 260,000; Full time

Job summary

Legend Biotech in Somerset, NJ is seeking a Director, Regulatory CMC to lead global regulatory strategies across late-stage development and post-approval lifecycle for commercial products.

You will provide strategic regulatory leadership to cross-functional teams, interact with Health Authorities, and drive continuous improvement in CMC processes.

This role requires an advanced degree and 10+ years in biotech/pharma with strong leadership skills.

Qualifications

• Advanced degree in life sciences, biotechnology, pharma, engineering, or related discipline.
• 10+ years in biotechnology or pharmaceutical industry.
• 7+ years Regulatory CMC experience for biologics/cell therapy; CAR-T exposure desirable.
• Global CMC regulatory experience.
• Experience leading late-stage programs and lifecycle management.
• Strong leadership, strategic thinking, and technical writing skills.
• Ability to manage multiple programs.

Responsibilities

• Develop, lead, and execute global CMC regulatory strategies for late-stage and post-approval lifecycle.
• Provide strategic regulatory leadership to cross-functional teams and mitigate regulatory risks.
• Serve as the primary Regulatory CMC representative on cross-functional teams.
• Lead regulatory CMC planning, submissions, and interactions with Health Authorities.
• Establish partnerships with internal and external stakeholders to meet regulatory objectives.
• Drive continuous improvement of regulatory CMC processes and knowledge management.
• Guide and support junior staff as applicable.

Skills

Regulatory leadership

CMC regulatory

Cross-functional collaboration

Strategic thinking

Technical writing

Communication

Education

Advanced degree in life sciences or related field

Job description

Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ.

Key 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 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.

#Li-AS1

#Li-Hybrid

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.

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.

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