Director, Regulatory CMC — Cell & Gene Therapy

Legendcareers; New Jersey; Hybrid; USD 194,000 - 254,000; Full time

Job summary

Legend Biotech is a global biotechnology company focused on advancing cell therapies, with headquarters in Bridgewater, New Jersey, and a base in Somerset. The Director, Regulatory CMC will lead global regulatory strategies for late-stage programs and post-approval lifecycle management within the Regulatory Affairs team based in New Jersey.

The role requires an advanced life sciences degree, 10+ years in biotech/pharma, and 7+ years in Regulatory CMC for biologics and cell/gene therapies,

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; CAR-T experience is desirable.
• Global CMC regulatory experience.
• Strong leadership, communication, and technical writing skills.

Responsibilities

• Develop, lead, and execute global CMC regulatory strategies for late-stage development and post-approval lifecycle management.
• Provide strategic regulatory leadership to cross-functional teams, guiding development and manufacturing strategies and risk mitigation.
• Serve as primary Regulatory CMC representative on cross-functional program teams and governance committees.
• Lead regulatory CMC planning, submissions, and interactions with health authorities.
• Establish and maintain partnerships with internal and external stakeholders to achieve regulatory objectives.
• Drive continuous improvement in regulatory CMC processes, best practices, and knowledge management.
• Guide and support junior staff as applicable.

Skills

Leadership

Strategic thinking

Communication

Technical writing

Education

Advanced degree

Job description

Legend Biotech is a global biotechnology company focused on advancing cell therapies, with headquarters in Bridgewater, New Jersey, and a base in Somerset. The Director, Regulatory CMC will lead global regulatory strategies for late-stage programs and post-approval lifecycle management within the Regulatory Affairs team based in New Jersey.

The role requires an advanced life sciences degree, 10+ years in biotech/pharma, and 7+ years in Regulatory CMC for biologics and cell/gene therapies,