Regulatory Affairs Manager (m/f/d)

GULP – experts united; Berlin; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading medical technology company seeks a Regulatory Affairs Manager to join its Berlin team. The role involves managing marketing authorization processes, ensuring compliance with regulations, and requires a strong background in pharmacy or a related field. Excellent communication skills in both German and English are essential. The position offers flexible working conditions and various employee benefits.

Leistungen

Flexible working hours & mobile working

30 days vacation

Occasion-related paid leave

Various health offers

In-house and external catering options

Parking facilities for electric cars

Qualifikationen

• Experience in regulatory affairs is required.
• Competence in preparing marketing authorization documents.
• Fluent in English and German.

Aufgaben

• Manage documentation for approval of pharmaceutical products.
• Cooperate with external experts and authorities.
• Support drug development from a regulatory perspective.

Kenntnisse

Fluency in German and English

Strong communication skills

Independent, precise and structured work

Ausbildung

Completed studies in pharmacy, chemistry, biology

Tools

MS Office

Adobe Acrobat

Jobbeschreibung

Regulatory Affairs Manager (m/f/d), Berlin

Client:

Location:

Berlin, Germany

Job Category:

Other

-

EU work permit required:

Yes

Job Reference:

936301a0e9b6

Job Views:

3

Posted:

21.06.2025

Expiry Date:

05.08.2025

Job Description:

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
• 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
• 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.

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