Director, Regulatory CMC – Cell & Gene Therapy

Legend Biotech; New Jersey; On-site; USD 194,000 - 254,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech, based in Somerset, NJ, seeks a Director of Regulatory CMC to lead global strategies for late-stage and post-approval lifecycle management, driving alignment with manufacturing and development teams.

You will act as the primary Regulatory CMC representative on cross-functional teams, shaping submissions and regulatory strategies while mentoring junior staff and ensuring compliance across global markets.

Qualifications

• 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 with ability to critically evaluate data from diverse disciplines.
• Global CMC regulatory experience including lifecycle management, supplements, variations and post-approval commitments.

Responsibilities

• Develop, lead, and execute global CMC regulatory strategies across commercial products and development-stage programs.
• Provide strategic regulatory leadership to cross-functional teams and drive risk mitigation plans.
• Serve as primary Regulatory CMC representative on cross-functional program teams and governance committees.
• Lead regulatory CMC planning, submissions, and interactions with Health Authorities.
• Build partnerships with internal and external stakeholders to achieve regulatory objectives.
• Drive continuous improvement in regulatory processes, knowledge management, and best practices.
• Guide and support junior staff as applicable.

Skills

Regulatory leadership

CMC regulatory

Biologics experience

Cross-functional collaboration

Strategic thinking

Communication

Technical writing

Education

Advanced life sciences degree

Job description

Legend Biotech, based in Somerset, NJ, seeks a Director of Regulatory CMC to lead global strategies for late-stage and post-approval lifecycle management, driving alignment with manufacturing and development teams.

You will act as the primary Regulatory CMC representative on cross-functional teams, shaping submissions and regulatory strategies while mentoring junior staff and ensuring compliance across global markets.