Manager, Project Management, Regulatory (Biotechnology)

TL;DR

Manager, Project Management, Regulatory (Biotechnology): Coordinating project activities for Cell & Gene Therapy development programs with an accent on regulatory filings, timeline monitoring, and cross-functional communication. Focus on facilitating IND submissions, tracking resource utilization, and managing operational support throughout the product development lifecycle.

Location: Somerset, New Jersey, United States (Hybrid). Must be authorized to work in the United States

Salary: $110,706 - $145,303 USD

Company

A global biotechnology company dedicated to treating and curing life-threatening diseases through advanced cell therapies.

What you will do

• Coordinate day-to-day project activities across Research, CMC, Quality, Regulatory Affairs, and Clinical Operations.
• Develop and maintain project timelines, action-item trackers, and key project documentation.
• Facilitate project team meetings and ensure timely completion of follow-up actions.
• Support the preparation and coordination of IND submissions and other regulatory filings.
• Manage project budgets, purchase orders, and resource utilization in collaboration with Finance.
• Prepare project dashboards and materials for leadership reviews and governance meetings.

Requirements

• Bachelor's degree in Life Sciences, Biotechnology, or a related scientific field (Master's preferred).
• 1–3 years of project coordination or management experience within the biotech or pharmaceutical industry.
• Basic understanding of the drug development process and IND submissions.
• Proficiency with MS Office and project management tools like Microsoft Project or Smartsheet.
• Must be authorized to work in the United States (E-Verify).

Nice to have

• Familiarity with Cell & Gene Therapy or biologics.
• Experience working in cross-functional teams within a regulated environment.
• PMP or CAPM certification.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with company match (vests on day one).
• Generous paid parental leave (8 weeks) and a comprehensive PTO policy.
• FSA and HSA options, life and disability insurance.
• Supportive culture with well-being initiatives and peer-to-peer recognition.