Director, Regulatory CMC — Cell & Gene Therapy

Socket.dev; 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

Paid time off

Job summary

Legend Biotech, based in New Jersey, is seeking a Director of Regulatory CMC to lead global strategies for biologics and cell therapy programs. You will guide late‑stage development and post‑approval lifecycle activities from Somerset, NJ.

The role requires deep CMC expertise, strong leadership, and a proven track record in cross‑functional collaboration, with responsibility for regulatory submissions and HA interactions.

Qualifications

• 10+ years of biotechnology or pharmaceutical industry experience.
• 7+ years of Regulatory CMC experience for biologics and cell/gene therapies.
• CAR‑T experience is a plus.
• Strong CMC technical background and data evaluation skills.
• Experience leading late‑stage programs and lifecycle management.
• Global CMC regulatory experience.
• Leadership, communication, and technical writing abilities.

Responsibilities

• Lead global CMC regulatory strategies for commercial products and development programs.
• Provide strategic regulatory leadership to cross‑functional teams.
• Serve as primary Regulatory CMC representative on program teams and governance.
• Lead and coordinate regulatory CMC planning, submissions, and HA interactions.
• Build partnerships with internal and external stakeholders to meet regulatory objectives.
• Drive process improvements in regulatory CMC practices and knowledge management.
• Mentor and guide junior staff as applicable.

Skills

CMC leadership

Biologics knowledge

Regulatory submissions

Cross-functional leadership

Strategic thinking

Regulatory strategy

Education

Advanced degree in life sciences

Job description

Legend Biotech, based in New Jersey, is seeking a Director of Regulatory CMC to lead global strategies for biologics and cell therapy programs. You will guide late‑stage development and post‑approval lifecycle activities from Somerset, NJ.

The role requires deep CMC expertise, strong leadership, and a proven track record in cross‑functional collaboration, with responsibility for regulatory submissions and HA interactions.