Regulatory Project Manager, Cell & Gene Therapy

Legend Biotech EU; Maine; On-site; USD 111,000 - 145,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Paid time off & holidays

Job summary

Legend Biotech is seeking a Manager, Regulatory Project Management to support planning and execution of Cell & Gene Therapy programs in Somerset, NJ. The role focuses on coordinating timelines, dashboards, and cross-functional communication to ensure milestones are met.

The successful candidate will report to the Director of Project Management Regulatory and bring 1–3 years of biotech/pharma project coordination experience, with strong organizational and communication skills.

Qualifications

• Bachelor’s degree in Life Sciences, Biotech, Biomedical Engineering, Pharmacy, or related field.
• 1–3 years of project coordination or management experience in biotech or pharma.
• Familiarity with Cell & Gene Therapy and IND regulatory processes.

Responsibilities

• Coordinate day-to-day project activities across cross-functional teams.
• Develop and maintain project timelines, action-item trackers, meeting agendas, and other key project documentation.
• Schedule and facilitate project team meetings, prepare meeting minutes, and follow up on action items to support timely completion.
• Monitor project progress and promptly escalate potential risks, delays, and resource constraints to project leadership.
• Support the preparation and coordination of activities related to IND submissions and other regulatory filings.
• Track project budgets, purchase orders, invoices, and resource utilization in collaboration with Finance and functional leads.

Skills

Project coordination

Cross-functional teamwork

Communication skills

Education

Bachelor’s degree in Life Sciences/related field

Master’s degree preferred

Tools

Microsoft Project

Smartsheet

Microsoft Office Suite

Job description

Legend Biotech is seeking a Manager, Regulatory Project Management to support planning and execution of Cell & Gene Therapy programs in Somerset, NJ. The role focuses on coordinating timelines, dashboards, and cross-functional communication to ensure milestones are met.

The successful candidate will report to the Director of Project Management Regulatory and bring 1–3 years of biotech/pharma project coordination experience, with strong organizational and communication skills.