Regulatory Project Manager – Cell & Gene Therapy

Legend Biotech USA; New Jersey; On-site; USD 85,000 - 125,000; Full time

Job summary

Legend Biotech USA seeks a motivated Manager, Regulatory Project Management to support planning and execution of cell & gene therapy programs. You will coordinate activities across functions, monitor timelines, and assist with regulatory filings to ensure milestones are met.

The role emphasizes collaboration in a fast-paced biotech environment, with a path for growth and development within the Regulatory Project Management team at our Somerset, NJ site.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or related field; Master’s preferred.
• 1–3 years of experience in project coordination/PM support in biotech/pharma/life sciences.
• Familiarity with Cell & Gene Therapy, biologics, or related development is preferred.

Responsibilities

• Coordinate day-to-day activities across Research, CMC, Quality, Regulatory, Clinical Operations, and external partners.
• Develop and maintain project timelines, trackers, agendas, and documentation.
• Schedule and facilitate meetings; prepare minutes and follow up on actions.

Skills

Project coordination

Cross-functional teamwork

Regulatory knowledge

Communication

Education

Bachelor's degree in Life Sciences / biotech

Master's degree preferred

Tools

Microsoft Project

Smartsheet

Excel

Job description

Legend Biotech USA seeks a motivated Manager, Regulatory Project Management to support planning and execution of cell & gene therapy programs. You will coordinate activities across functions, monitor timelines, and assist with regulatory filings to ensure milestones are met.

The role emphasizes collaboration in a fast-paced biotech environment, with a path for growth and development within the Regulatory Project Management team at our Somerset, NJ site.