Regulatory Affairs Specialist

Vor 3 Tagen


Düsseldorf, Nordrhein-Westfalen, Deutschland Hobson Prior Vollzeit

Job Title: Regulatory Affairs Manager

About the Role:

Hobson Prior is seeking a highly skilled Regulatory Affairs Manager to join our team. As a Regulatory Affairs Manager, you will be responsible for navigating approval strategies and maintaining marketing authorisations in compliance with legislation.

Key Responsibilities:

  • Develop and Evaluate Approval Strategies: Develop and evaluate approval strategies for projects, competitive claims, and OTC switches to ensure compliance with national and European legislation.
  • Prepare and Submit Approval Documents: Prepare, coordinate, and submit approval documents for changes and extensions in line with national and European legislation.
  • Ensure Regulatory Compliance: Coordinate approval procedures and ensure regulatory compliance to maintain marketing authorisations.

Requirements:

  • Scientific Discipline: Degree in a scientific discipline is required.
  • Regulatory Affairs Experience: 8+ years of experience in regulatory affairs/drug approval into the DACH region is required.
  • Language Skills: Fluent in German and English is required.


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