Regulatory Project Manager - Cell & Gene Therapy

Legend Biotech US; New Jersey; On-site; USD 111,000 - 145,000; Full time

Benefits offered by this job

401(k) match on day one

Eight weeks parental leave

Paid time off and eleven holidays

Job summary

Legend Biotech US in Somerset, New Jersey, is seeking a Manager, Regulatory Project Management to support planning and execution of Cell & Gene Therapy programs. You will coordinate activities across Research, CMC, Quality, Regulatory Affairs, Clinical Operations and external partners to keep development milestones on track.

The role emphasizes cross-functional collaboration, meticulous documentation, meeting management, and strengthening program governance in a fast-paced biotech environment.

Qualifications

• Bachelor's degree in Life Sciences or related field; master's preferred.
• 1–3 years of project coordination or admin support in biotech/pharma.
• Familiarity with Cell & Gene Therapy and IND submissions is preferred.

Responsibilities

• Coordinate day-to-day project activities across cross-functional teams.
• Develop and maintain project timelines and trackers.
• Schedule meetings, prepare minutes, and follow up on action items.
• Monitor project progress and elevate risks or delays to leadership.
• Support IND submissions and regulatory filings.
• Assist with dashboards and leadership reports.
• Onboard new team members and coordinate access to systems.
• Provide general administrative support to the cross-functional team.

Skills

Project coordination

Cross-functional collaboration

Regulatory affairs knowledge

Communication skills

Education

Bachelor's degree in Life Sciences or related field

Master's degree preferred

Tools

Microsoft Office

Microsoft Project

Smartsheet

Job description

Legend Biotech US in Somerset, New Jersey, is seeking a Manager, Regulatory Project Management to support planning and execution of Cell & Gene Therapy programs. You will coordinate activities across Research, CMC, Quality, Regulatory Affairs, Clinical Operations and external partners to keep development milestones on track.

The role emphasizes cross-functional collaboration, meticulous documentation, meeting management, and strengthening program governance in a fast-paced biotech environment.