Regulatory Project Manager – Cell & Gene Therapy

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Parental leave

Job summary

Legend Biotech in Somerset, NJ seeks a Manager, Regulatory Project Management to coordinate cell and gene therapy development programs. You will work with Research, CMC, Quality, Regulatory Affairs, Clinical Operations and external partners to keep timelines on track and ensure milestones are met.

Reporting to the Director of Project Management Regulatory, you will manage meeting materials, dashboards, budgets and onboarding.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or related field; Master's preferred.
• 1–3 years in project coordination, project management, program support, or administrative project support within biotech/pharma.
• Familiarity with Cell & Gene Therapy, biologics, or related therapeutic development is preferred.
• Experience working in cross-functional teams within a regulated environment is preferred.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Excellent written, verbal, and interpersonal communication skills; PMP or CAPM is a plus but not required.

Responsibilities

• Coordinate day-to-day project activities across cross-functional teams, including Research, CMC, Quality, Regulatory Affairs, Clinical Operations, and external partners.
• 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.
• Assist with preparation of project dashboards, presentations, reports, and materials for leadership reviews and governance meetings.
• Assist with onboarding new project team members by coordinating access to systems, project documentation, and team resources.
• Provide general administrative support to the cross function as needed.
• Support vendor onboarding, contract routing, purchase requisitions, and invoice processing in partnership with Procurement and Finance.
• Facilitate clear, effective communication among internal stakeholders and external collaborators (CROs and CDMOs).
• Ensure project documentation is accurate, well organized, and maintained per company procedures.
• Contribute to continuous improvement of PM processes, templates, and best practices.

Skills

Project coordination

Cross-functional teamwork

Communication

Organizational skills

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Project

Smartsheet

Microsoft Office

Job description

Legend Biotech in Somerset, NJ seeks a Manager, Regulatory Project Management to coordinate cell and gene therapy development programs. You will work with Research, CMC, Quality, Regulatory Affairs, Clinical Operations and external partners to keep timelines on track and ensure milestones are met.

Reporting to the Director of Project Management Regulatory, you will manage meeting materials, dashboards, budgets and onboarding.