Global Director, Regulatory CMC — Cell Therapy

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid parental leave

Generous PTO & company holidays

Job summary

Legend Biotech seeks a Director, Regulatory CMC to lead global CMC regulatory strategies for late-stage and post-approval programs. Based in Somerset, NJ, you will partner with cross-functional teams to shape development and manufacturing plans and ensure alignment with regulatory expectations.

Responsibilities include submissions, health authority interactions, and lifecycle management, with a focus on cell and gene therapies.

Qualifications

• 10+ years of biotechnology or pharmaceutical industry experience.
• 7+ years of Regulatory CMC experience for biologics, cell and gene therapy.
• Direct CAR-T experience is desired.
• Strong CMC technical background and ability to evaluate data from diverse disciplines.
• Experience leading late-stage programs and post-approval lifecycle management.
• Global CMC regulatory experience.

Responsibilities

• Develop, lead, and execute global CMC regulatory strategies across commercial products and development programs.
• Provide strategic regulatory leadership to cross-functional teams and mitigate regulatory risks.
• Serve as the primary Regulatory CMC representative on cross-functional program teams and governance committees.
• Lead and coordinate Regulatory CMC planning, submissions, and interactions with Health Authorities.
• Establish and maintain partnerships with internal and external stakeholders to drive regulatory objectives.
• Drive continuous improvement of Regulatory CMC processes, best practices, and knowledge management.
• Guide and support junior staff as applicable.

Skills

Leadership

Strategic thinking

Communication

Technical writing

Program management

Global regulatory experience

Education

Advanced degree in life sciences or related field

Job description

Legend Biotech seeks a Director, Regulatory CMC to lead global CMC regulatory strategies for late-stage and post-approval programs. Based in Somerset, NJ, you will partner with cross-functional teams to shape development and manufacturing plans and ensure alignment with regulatory expectations.

Responsibilities include submissions, health authority interactions, and lifecycle management, with a focus on cell and gene therapies.