Regulatory Affairs Manager (m/f/d)
GULP – experts united
Berlin
Our client, a leading medical technology company specializing in the development and production of solutions for cancer treatment, is looking for you and your expertise as Regulatory Affairs Manager (m / f / d) for the Berlin location at the earliest possible date.
Here's what our clients offer
- Flexible working hours & mobile working
- Permanent employment contract
- 30 days vacation
- Occasion-related paid leave, e.g. for relocation, cancer screening
- Various health offers, e.g. health insurance health days
- In-house and external catering options
- Parking facilities and the option to charge electric cars at employee prices
Your tasks
- Creation and maintenance of documentation for the approval of (radio)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.
Your profile
- 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.
Vor 30+ Tagen