Director, Regulatory CMC — Global Biologics Submissions

Legend Biotech US; New Jersey; Hybrid; USD 194,000 - 254,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company-m.

Paid parental leave

Paid time off (vacation, personal, etc

Flexible spending accounts / Health-s

Life and AD&D insurance

Job summary

Legend Biotech US is seeking a Director, Regulatory CMC based in Somerset, NJ, to lead global CMC regulatory strategies for late-stage and post-approval programs within Regulatory Affairs. You will influence development and manufacturing strategies and serve as the primary Regulatory CMC representative on cross-functional teams.

The role requires 10+ years in biotech/pharma with 7+ years in Regulatory CMC, and a strong CMC background, including life sciences expertise and CAR-T experience is a

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.
• Direct CAR-T experience is desirable.
• Strong leadership, strategic thinking, and technical writing skills.
• Global CMC regulatory experience and lifecycle management experience.

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 influence development/manufacturing strategies.
• Serve as primary Regulatory CMC representative on program teams and governance.
• Lead CMC planning, preparation of submissions, and interaction with Health Authorities.
• Establish partnerships with internal and external stakeholders to ensure objectives.
• Drive continuous improvement of regulatory processes and knowledge management.
• Guide and support junior staff as applicable.

Skills

Regulatory leadership

Strategic thinking

Communication

Technical writing

Cross-functional collaboration

CMC data evaluation

Education

Advanced degree in life sciences

Job description

Legend Biotech US is seeking a Director, Regulatory CMC based in Somerset, NJ, to lead global CMC regulatory strategies for late-stage and post-approval programs within Regulatory Affairs. You will influence development and manufacturing strategies and serve as the primary Regulatory CMC representative on cross-functional teams.

The role requires 10+ years in biotech/pharma with 7+ years in Regulatory CMC, and a strong CMC background, including life sciences expertise and CAR-T experience is a