Manager, Project Management, Regulatory
Legend Biotech
August 25, 2026
On-site
Somerset, NJ
Corporate Functions
Role Overview
- Reporting to the Director of Project Management Regulatory, coordinate planning and execution of Cell & Gene Therapy development programs; support project coordination, documentation, meeting management, and operational support throughout the product development lifecycle.
Key Responsibilities
- Coordinate day-to-day project activities across cross-functional teams (Research, CMC, Quality, Regulatory Affairs, Clinical Operations) and external partners.
- Develop and maintain project timelines, action-item trackers, meeting agendas, and related documentation.
- Schedule/facilitate meetings, prepare minutes, and track action items.
- Monitor progress; escalate risks, delays, and resource constraints.
- Support IND submission and other regulatory filing activities.
- Track budgets, purchase orders, invoices, and resource utilization with Finance and functional leads.
- Support leadership dashboards, presentations, reports, and governance/investor/partner updates.
- Onboard new team members (systems access, documentation, resources).
- Provide administrative support as needed.
- Support vendor onboarding, contract routing, purchase requisitions, and invoice processing.
- Facilitate communication among internal stakeholders and external collaborators (CROs, CDMOs).
- Maintain accurate, well-organized project documentation per company procedures.
- Contribute to continuous improvement of processes/templates/best practices.
Requirements
- Bachelor’s degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or related field; Master’s preferred.
- 1–3 years in project coordination/management/program or administrative project support in biotech/pharma/life sciences.
- Preferred: familiarity with Cell & Gene Therapy/biologics.
- Basic understanding of drug development (preclinical, CMC, IND submissions).
- Preferred: cross-functional experience in a regulated environment.
- Strong organizational and communication skills.
- Proficient with Microsoft Office and tools such as Microsoft Project/Smartsheet.
- PMP/CAPM is a plus (not required).
Benefits (if selected)
- Medical, dental, vision; 401(k) match; 8 weeks paid parental leave after 3 months; paid time off including vacation/personal/sick/floating holidays plus 11 company holidays.
- Performance-based bonus and/or equity (eligible roles).
Application Instructions
- Authorized to work in the United States; if selected, complete Form I-9 (E-Verify verification).
- Reporting to the Director of Project Management Regulatory, coordinate planning and execution of Cell & Gene Therapy development programs; support project coordination, documentation, meeting management, and operational support throughout the product development lifecycle.
Key Responsibilities
- Coordinate day-to-day project activities across cross-functional teams (Research, CMC, Quality, Regulatory Affairs, Clinical Operations) and external partners.
- Develop and maintain project timelines, action-item trackers, meeting agendas, and related documentation.
- Schedule/facilitate meetings, prepare minutes, and track action items.
- Monitor progress; escalate risks, delays, and resource constraints.
- Support IND submission and other regulatory filing activities.
- Track budgets, purchase orders, invoices, and resource utilization with Finance and functional leads.
- Support leadership dashboards, presentations, reports, and governance/investor/partner updates.
- Onboard new team members (systems access, documentation, resources).
- Provide administrative support as needed.
- Support vendor onboarding, contract routing, purchase requisitions, and invoice processing.
- Facilitate communication among internal stakeholders and external collaborators (CROs, CDMOs).
- Maintain accurate, well-organized project documentation per company procedures.
- Contribute to continuous improvement of processes/templates/best practices.
Requirements
- Bachelor’s degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or related field; Master’s preferred.
- 1–3 years in project coordination/management/program or administrative project support in biotech/pharma/life sciences.
- Preferred: familiarity with Cell & Gene Therapy/biologics.
- Basic understanding of drug development (preclinical, CMC, IND submissions).
- Preferred: cross-functional experience in a regulated environment.
- Strong organizational and communication skills.
- Proficient with Microsoft Office and tools such as Microsoft Project/Smartsheet.
- PMP/CAPM is a plus (not required).
Benefits (if selected)
- Medical, dental, vision; 401(k) match; 8 weeks paid parental leave after 3 months; paid time off including vacation/personal/sick/floating holidays plus 11 company holidays.
- Performance-based bonus and/or equity (eligible roles).
Application Instructions
- Authorized to work in the United States; if selected, complete Form I-9 (E-Verify verification).