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Global Regulatory Lead, vaccines

An exciting opportunity for a Global Regulatory Lead to work with one of our large top 10 biopharma companies, working on their Vaccines portfolio.

Locations can be US or Belgium to align with client timezone and key stakeholders.

This role will include the following:

  • Responsible for regulatory strategy
  • Preparation of file content, preparing plans
  • Coordinate/submit responses to RTQs
  • Liaising directly with the health authority,
  • Partner with Project Manager to track/monitor deliverables.
  • Review submission packages (including labeling, RTQs and initial filings) to ensure alignment with company position and agency requirements.

We require strong knowledge of US regulations (FDA)
You should have previous experience in clinical regulatory and labeling

The ideal candidate will have:

  • Experience working in matrixed environment (RA, clinical, cmc, safety, stats, labeling, etc.) in the development and/or life cycle space.
  • Be able to hit the ground running with more minimal onboarding; be a self-starter; have the ability to network and problem solve; be a strong communicator (written and spoken)
  • Contract Type:

    1099 / W2

  • Location:

    US or Belgium

  • Duration:

    6 - 12 month

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