Regulatory Project Manager (Part time)

The Execu|Search Group · Woburn, Massachusetts, United States

Location
Woburn
Job Type
Contract
Posted
June 16, 2026

Job Description

Responsibilities

:
  • Partner with Regulatory leads to manage regulatory filing sub teams and sub team operations, including the coordination, prioritization, and tracking of regulatory activities associated with development and post-marketing activities
  • Develop and maintain high level and detailed regulatory timelines that utilize project management software tools, with input from functional leads, cross-functional teams, and senior management, assuring that regulatory timelines are aligned with global program strategies
  • Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays
  • Track functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and regulatory / submission team activities to ensure overall adherence to timelines
  • Identify risks and mitigation strategies as well as opportunities for consistency and ef...
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