Regulatory Project Manager, Cell & Gene Therapy

Legend Biotech; 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

Paid parental leave

Job summary

Legend Biotech is seeking a Manager, Regulatory Project Management in Somerset, NJ to support planning and execution of Cell & Gene Therapy programs. You will coordinate activities, monitor timelines, and provide administrative support to ensure milestones are met, working closely with Regulatory and cross-functional teams.

The role suits an early-career project manager with biotech/pharma exposure, eager to grow in a fast-paced environment, with emphasis on documentation, communication, and

Qualifications

• Bachelor's degree in Life Sciences or related field; Master's preferred.
• 1–3 years of experience in project coordination within biotech/pharma.
• Familiarity with Cell & Gene Therapy, biologics preferred.
• Basic understanding of drug development including preclinical, CMC, IND submissions.
• Experience in cross-functional, regulated environments.
• Strong organizational and communication skills; able to manage multiple priorities.
• Proficiency with MS Office and project tools (MS Project/Smartsheet); PMP/CAPM a plus.

Responsibilities

• Coordinate day-to-day project activities across cross-functional teams.
• Develop and maintain project timelines, action-item trackers, meeting agendas, and documentation.
• Schedule and facilitate meetings; prepare minutes and action-item follow-ups.
• Monitor progress and flag risks to project leadership.
• Support preparation of IND submissions and other regulatory filings.
• Track budgets, POs, invoices, and resource use with Finance.
• Prepare dashboards, reports, and materials for leadership reviews.
• Onboard new team members by coordinating access to systems and resources.
• Provide general administrative support to the cross-functional team.
• Support vendor onboarding, contract routing, and invoice processing.
• Facilitate communication with CROs/CDMOs.
• Ensure documentation is organized per procedures.
• Contribute to process improvements in PM practices.

Skills

Project coordination

Cross-functional teamwork

Communication skills

Administrative support

Education

Bachelor's degree in Life Sciences

Master's degree preferred

Tools

Microsoft Office

Microsoft Project

Smartsheet

Job description

Legend Biotech is seeking a Manager, Regulatory Project Management in Somerset, NJ to support planning and execution of Cell & Gene Therapy programs. You will coordinate activities, monitor timelines, and provide administrative support to ensure milestones are met, working closely with Regulatory and cross-functional teams.

The role suits an early-career project manager with biotech/pharma exposure, eager to grow in a fast-paced environment, with emphasis on documentation, communication, and