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Berlin-Chemie AG: freut sich auf Ihre Bewerbung

EXPLOIT YOUR POTENTIAL AS

International Regulatory Affairs Manager (m/f/d)

 Site
Berlin
Specialist field
Regulatory Affairs
Career level
Experienced professionals
Commencement date
with immediate effect
Fixed-term contract
Permanent
Working time
Full-time
Your tasks

Your tasks

You are responsible for the acquisition and regulatory management of international marketing authorisations for pharmaceutical products, medical devices and food supplements. This involves conducting all necessary activities to maintain existing or acquire new authorisations, registrations and certifications in the Eastern European and CIS countries where our products are marketed.

To do so, you will evaluate the required regulatory activities and prepare the respective documents and submission schedules under consideration of local provisions and laws of the various countries.

Furthermore, you will negotiate the necessary steps for acquiring and maintaining product authorisations, registrations and certifications with licensors and Berlin-Chemie AG representatives abroad as well as with the relevant organisations and authorities. Your excellent organisational skills enable you to prepare all regulatory activities in compliance with valid GMP regulations and Best Practice guidelines and ensure that this information flows smoothly within the company.

The conduct of due diligence activities with external service providers is also part of your remit. You will organise and evaluate regulatory documentation provided by them to contribute to important decisions regarding the acquisition of authorisations, distribution rights and documentation.

Finally, you will continuously monitor and analyse all amendments and updates of the relevant regulatory legislations, regulations and deadlines of the respective countries and act as the contact person for regulatory questions.

Your profile

Your profile

  • University degree in pharmacy, chemistry, human medicine or a comparable scientific qualification
  • Several years' professional experience in the field of regulatory affairs in the pharmaceutical industry, the medical devices sector or at a relevant authority
  • Extensive regulatory knowledge in the area of pharmaceutical products, medical devices and food supplements in an international context
  • Knowledge and understanding of the EU and non-EU medical device and pharmaceutical legislation
  • Fluent English language skills, Russian language skills are an advantage
  • Very good knowledge of MS Office
  • Willingness to engage in occasional international travel

Have we aroused your interest? Then we look forward to receiving your informative online application stating your earliest possible starting date and salary requirements.

 

Your Contact


Ulf Kaiser

Human Resources Manager

030 6707-2944