Regulatory Affairs Specialist
Vor 3 Tagen
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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