Regulatory Project Manager, Cell & Gene Therapy Programs

BioSpace; New Jersey; On-site; USD 111,000 - 145,000; Full time

Job summary

Legend Biotech, based in Somerset, NJ, seeks a Manager, Regulatory Project Management to join the Regulatory team. You will coordinate cross-functional activities, maintain timelines, and support IND submissions to ensure milestones are met in a fast-paced cell & gene therapy environment.

The role emphasizes collaboration with R&D, CMC, QA, and external partners. A life sciences degree with 1–3 years in project coordination is required, with PMP/CAPM as a plus.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy or related field.
• 1–3 years in project coordination/management within biotech/pharma.
• Familiarity with Cell & Gene Therapy or biologics preferred.
• Understanding of drug development processes and IND submissions.
• Experience in cross-functional teams within a regulated environment.
• PMP or CAPM is a plus but not required.

Responsibilities

• Coordinate day-to-day project activities across cross-functional teams.
• Develop and maintain project timelines, action-item trackers, and agendas.
• Schedule and facilitate meetings, minutes, and follow-ups.
• Monitor progress and escalate risks to leadership.
• Support IND submissions and regulatory filings coordination.
• Track budgets, POs, and resource use with Finance.
• Prepare dashboards, presentations, and leadership materials.
• Onboard new team members and ensure system access.
• Provide general admin support and vendor onboarding.
• Maintain project documentation and drive process improvements.

Skills

Organizational skills

Communication

Cross-functional collaboration

Regulated environment experience

Education

Bachelor's degree in Life Sciences

Master's degree preferred

Tools

Microsoft Project

Smartsheet

Microsoft Office

Job description

Legend Biotech, based in Somerset, NJ, seeks a Manager, Regulatory Project Management to join the Regulatory team. You will coordinate cross-functional activities, maintain timelines, and support IND submissions to ensure milestones are met in a fast-paced cell & gene therapy environment.

The role emphasizes collaboration with R&D, CMC, QA, and external partners. A life sciences degree with 1–3 years in project coordination is required, with PMP/CAPM as a plus.