Regulatory Project Manager — Cell & Gene Therapy

Socket.dev; New Jersey; On-site; USD 111,000 - 145,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid parental leave

Vacation and sick time

Commuter benefits

Job summary

Legend Biotech is seeking a Manager, Regulatory Project Management, to support planning and execution of Cell & Gene Therapy development programs. Based in Somerset, NJ, you will coordinate activities, track timelines, and provide administrative support to ensure milestones are met.

The role targets individuals with 1–3 years in biotech/pharma project coordination, strong organization, and collaboration skills, and familiarity with regulatory processes.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or related field; Master’s preferred.
• 1–3 years of experience 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.
• Strong organizational, communication, and cross-functional collaboration skills.

Responsibilities

• Coordinate day-to-day project activities across cross-functional teams (Research, CMC, Quality, Regulatory Affairs, Clinical Operations, external partners).
• Develop and maintain project timelines, action-item trackers, agendas, and documentation.
• Schedule and facilitate meetings, prepare minutes, and follow up on action items to ensure timely completion.
• Monitor progress and escalate risks, delays, or resource constraints to leadership.
• Support IND submissions and other regulatory filings coordination.

Skills

Project coordination

Cross-functional collaboration

Regulatory knowledge

MS Project

Smartsheet

Communication

Education

Bachelor's degree in Life Sciences

Master's degree preferred

Tools

Microsoft Project

Smartsheet

Excel

PowerPoint

Word

Job description

Legend Biotech is seeking a Manager, Regulatory Project Management, to support planning and execution of Cell & Gene Therapy development programs. Based in Somerset, NJ, you will coordinate activities, track timelines, and provide administrative support to ensure milestones are met.

The role targets individuals with 1–3 years in biotech/pharma project coordination, strong organization, and collaboration skills, and familiarity with regulatory processes.