Director, Regulatory CMC - Cell & Gene Therapy

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

Benefits offered by this job

Medical insurance

401(k) plan with company match

Paid parental leave

Vision coverage

Job summary

Legend Biotech in Somerset, NJ, is seeking a Director of Regulatory CMC to lead global regulatory strategies for late‑stage and post‑approval programs. You will guide cross‑functional teams, manage clinical and commercial lifecycle activities, and interact with Health Authorities to ensure compliant submissions.

The role requires an advanced life sciences degree and 10+ years in biotech/pharma, including Regulatory CMC and cell/gene therapy experience.

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 a plus.

Responsibilities

• Develop, lead, and execute global CMC regulatory strategies for commercial products and development programs.
• Provide strategic regulatory leadership to cross‑functional teams and manage regulatory risks and opportunities.
• Serve as primary Regulatory CMC representative on cross‑functional teams and governance committees.
• Lead regulatory CMC planning, submissions, and interactions with Health Authorities.
• Establish partnerships with internal and external stakeholders to execute regulatory objectives.

Skills

CMC regulatory expertise

Regulatory strategy

Leadership

Technical writing

Education

Advanced degree in life sciences/biotech

Job description

Legend Biotech in Somerset, NJ, is seeking a Director of Regulatory CMC to lead global regulatory strategies for late‑stage and post‑approval programs. You will guide cross‑functional teams, manage clinical and commercial lifecycle activities, and interact with Health Authorities to ensure compliant submissions.

The role requires an advanced life sciences degree and 10+ years in biotech/pharma, including Regulatory CMC and cell/gene therapy experience.