Director, Regulatory CMC – Global Cell Therapy Leadership

Merck & Co.; New Jersey; Hybrid; USD 194,000 - 254,000; Full time

Benefits offered by this job

Medical, dental, and vision

401(k) with company match

Paid parental leave (8 weeks)

Paid time off & holidays

Commuter benefits

Job summary

Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. The role leads global CMC regulatory strategies for late-stage development and post-approval lifecycle management, reporting to the Regulatory Affairs head.

You will provide strategic regulatory leadership to cross-functional teams, coordinate submissions with Health Authorities, and drive continuous improvement in regulatory processes while mentoring junior staff.

Qualifications

• Advanced degree in life sciences, biotechnology, pharma, or related discipline.
• 10+ years in biotechnology or pharmaceutical industry.
• 7+ years Regulatory CMC experience with biologics, cell and gene therapy.
• Direct CAR‑T experience is a plus.

Responsibilities

• Develop global CMC regulatory strategies for late-stage and post-approval programs.
• Provide strategic regulatory leadership to cross-functional teams.
• Lead CMC planning, submissions, and health authority interactions.
• Partner with internal and external stakeholders to meet regulatory objectives.
• Drive process improvements and knowledge management in Regulatory CMC.

Skills

Regulatory leadership

CMC expertise

Cross-functional teams

Regulatory writing

Lifecycle management

Education

Advanced degree in life sciences

Job description

Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. The role leads global CMC regulatory strategies for late-stage development and post-approval lifecycle management, reporting to the Regulatory Affairs head.

You will provide strategic regulatory leadership to cross-functional teams, coordinate submissions with Health Authorities, and drive continuous improvement in regulatory processes while mentoring junior staff.