Manager, Project Management, Regulatory

Legend Biotech is seeking a Manager, Regulatory Project Management as part of the Regulatory team based in Somerset, NJ. 

Role Overview

This role will be reporting to the Director of Project Management Regulatory. We are seeking a motivated, detail-oriented Project Manager to support the planning and execution of Cell & Gene Therapy development programs. Working closely with cross-functional teams, this individual will coordinate project activities, monitor timelines, facilitate effective communication, and provide administrative support to ensure projects are executed efficiently and meet key development milestones. This opportunity is well suited to an individual with early-career project management experience in the biotechnology or pharmaceutical industry who is eager to grow in a fast-paced, collaborative environment. The successful candidate will play a key role in 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, 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 Investigational New Drug (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, governance meetings, and investor or partner updates.
• 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, including contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs).
• Ensure project documentation is accurate, well organized, and maintained in accordance with company procedures.
• Contribute to the continuous improvement of project management processes, templates, and best practices.

Requirements

• Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or a related scientific field. Master's degree preferred.
• 1–3 years of experience in project coordination, project management, program support, or administrative project support within the biotechnology, pharmaceutical, or life sciences industry.
• Familiarity with Cell & Gene Therapy, biologics, or related therapeutic development is preferred.
• Basic understanding of the drug development process, including preclinical development, CMC activities, and IND submissions.
• 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.
• Proficiency with Microsoft Office (Excel, PowerPoint, Word) and project management tools such as Microsoft Project, Smartsheet, or similar platforms.
• PMP or CAPM certification is a plus but not required.

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