Regulatory Project Coordinator

Apex Systems

📍 Cambridge, Massachusetts, United States

Contract Business Operations Specialists

Job Description

Job#: 3039962

Job Description:

Contractor, Regulatory Project Coordinator

Our Cambridge based biotech client is seeking a regulatory project coordinator to join their mission‑driven team advancing innovative programs from early development through major regulatory milestones. In this role, you’ll support cross‑functional project management activities, maintain timelines, coordinate submissions, and help prepare teams for key health authority interactions.

What You’ll Do

  • Regulatory Coordination — Support major marketing applications and additional regulatory submissions.
  • Timeline Management — Maintain project plans, track updates, and escalate risks or resource conflicts.
  • Team Communication — Organize agendas, minutes, decision logs, task lists, and risk/mitigation tracking using SharePoint, OneNote, and OneDrive.
  • Cross‑Functional Support — Coordinate logistics and preparation for health authority meetings....
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