Director, Regulatory CMC — Global CAR-T Strategy

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 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.