Regulatory Affairs Specialist
vor 4 Wochen
We are seeking a Regulatory Affairs Manager to join our team at GULP – experts united. The ideal candidate will have experience in the field of regulatory affairs and be able to create and maintain documentation for the approval of pharmaceutical products in German and English.
Key Responsibilities:
- Creation and maintenance of documentation for the approval of pharmaceutical products in German and English.
- Writing and updating texts for product information.
- Handling national and international approval and renewal procedures and preparing applications for variations.
- Cooperation with external experts, service providers and authorities in Germany and abroad.
- Supporting regulatory aspects of change processes and ensuring compliance with drug safety requirements.
- Supporting drug development from a regulatory perspective.
- Researching and interpreting relevant laws and regulations in the area of marketing authorization.
Requirements:
- Completed studies in pharmacy, chemistry, biology or a comparable academic qualification.
- Experience in the field of regulatory affairs.
- Competence in the preparation and management of marketing authorization documents in English and in dealing with texts for product information.
- Fluency in written and spoken German and English.
- Independent, precise and structured way of working.
- Confident handling of MS Office, Adobe Acrobat and Internet research tools.
- Strong communication skills and quick comprehension.
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