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Senior Regulatory Affairs Specialist

IQVIA
remote
Courbevoie, France

About this role

About the Role As a Senior Regulatory Affairs Specialist at IQVIA, you will lead country-level regulatory activities and support the full product lifecycle across a diverse portfolio of medicinal products. This fixed-term 12-month contract involves ensuring regulatory compliance and providing strategic regulatory guidance to clients and Health Authorities. You will collaborate with global teams to drive high-quality outcomes that benefit patients and healthcare systems. What You'll Do

  • Lead and manage country-level regulatory activities for medicinal products, ensuring compliance with local regulatory requirements.
  • Prepare, coordinate, and submit regulatory documentation for lifecycle management activities, including variations, renewals, notifications, line extensions, MAH transfers, and new marketing authorization applications.

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