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Biotech Project Management Professional

Meet
San Rafael, CA Full Time
POSTED ON 3/5/2025
AVAILABLE BEFORE 3/21/2025

We are seeking a highly skilled Regulatory Project Manager Lead to join our team at Meet. As a key member of our regulatory affairs department, you will play a critical role in driving efficiency and cross-functional alignment in regulatory project management.

About the Role:

The Regulatory Project Manager Lead will be responsible for supporting and driving the efficiency of regulatory and cross-functional sub-teams, working closely with Global Regulatory Leads (GRLs). This role ensures seamless meeting management, timeline tracking, and cross-functional communication to align regulatory strategies with program objectives.

Key Responsibilities:

  • Support global regulatory strategies and operations to align with program goals.
  • Develop, manage, and track regulatory project timelines across the product lifecycle.
  • Coordinate with cross-functional Project Managers to align regulatory timelines with broader project plans.
  • Track global regulatory submissions, approvals, and commitments in designated systems.
  • Prepare project dashboards highlighting key regulatory activities and milestones.

Meeting Management & Support

  • Schedule and facilitate Global Regulatory Team (GRT) and Regulatory Advisory Board (RAB) meetings.
  • Document meeting minutes, action items, and track completion.
  • Provide high-level support for regulatory filings and other key regulatory meetings.

Cross-Functional Leadership

  • Act as a liaison between regulatory teams and other departments to ensure alignment.
  • Communicate regulatory updates and activities to internal and external stakeholders.
  • Contribute to process improvements within Regulatory Affairs and Project Management.

Qualifications:

  • Bachelor's degree in health or life sciences; Master's or MBA preferred.
  • 8 years of experience (6 with a Master's/MBA), preferably in biotech or pharmaceuticals.
  • Strong project management and regulatory knowledge with experience in drug development.
  • Excellent communication, problem-solving, and cross-functional collaboration skills.
  • Proficiency in tracking systems, timeline management, and regulatory processes.

This is an exciting opportunity to contribute to regulatory project success while driving efficiency and cross-functional alignment.

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