Regulatory Affairs Specialist
vor 3 Wochen
GULP – experts united is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements for our medical technology products.
Key Responsibilities:- Develop and maintain documentation for regulatory approvals in German and English.
- Write and update product information texts.
- Manage national and international approval and renewal procedures, preparing applications for variations.
- Collaborate with external experts, service providers, and authorities in Germany and abroad.
- Support regulatory aspects of change processes and ensure compliance with drug safety requirements.
- Contribute to drug development from a regulatory perspective.
- Research and interpret relevant laws and regulations in the area of marketing authorization.
- Completed studies in pharmacy, chemistry, biology, or a comparable academic qualification.
- Experience in regulatory affairs.
- Competence in preparing and managing marketing authorization documents in English and dealing with product information texts.
- Fluency in written and spoken German and English.
- Independent, precise, and structured work style.
- Confident handling of MS Office, Adobe Acrobat, and Internet research tools.
- Strong communication skills and quick comprehension.
GULP – experts united is a leading medical technology company specializing in cancer treatment solutions. We offer a dynamic work environment, flexible working hours, and a range of benefits, including 30 days of vacation and occasion-related paid leave.
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Regulatory Affairs Specialist
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Berlin, Berlin, Deutschland GULP – experts united VollzeitAre you a detail-oriented and organized professional with a passion for regulatory affairs in the pharmaceutical industry? Do you have a strong understanding of relevant legislation and experience with electronic submissions and internet-based systems?We are seeking a highly skilled Regulatory Affairs Specialist to join our team at GULP – experts united....
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Berlin, Berlin, Deutschland GULP – experts united VollzeitAre you a detail-oriented and organized professional with a passion for regulatory affairs in the pharmaceutical industry? Do you have a strong understanding of relevant legislation and experience with electronic submissions and internet-based systems?We are seeking a highly skilled Regulatory Affairs Specialist to join our team at GULP – experts united....
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