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International Regulatory Affairs Manager - EU (m/f/d)

Posted on Jan 15, 2019 by BERLIN-CHEMIE AG

Berlin, Berlin Germany
Immediate Start
Annual Salary
Health is our greatest wealth Together - for life

BERLIN-CHEMIE AG belongs to Italy's Menarini Group and researches as well as develops pharmaceutical products, distributing them in more than 30 countries. Our dedication to health is what unites the many different staff at our company. With our responsible work, we make sure that patients can rely on us. For we stand for life.

EXPLOIT YOUR POTENTIAL AS International Regulatory Affairs Manager - EU (m/f/d) Site Berlin Specialist field Regulatory Affairs Career level Experienced professionals Entry level from 1st March Fixed-term contract Fixed-term Working time Full-time Entry level from 1st March Fixed-term contract Fixed-term Working time Full-time

Your tasks

You are responsible for the acquisition and regulatory management of international marketing authorisations for pharmaceutical products. This involves conducting all necessary activities to maintain existing or acquire new authorisations, registrations and certifications in EU 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.

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

The offered position is limited until 30/06/2020.

Your profile

  • University degree in pharmacy, chemistry, human medicine or a comparable scientific qualification
  • Professional experience in the field of regulatory affairs in the pharmaceutical industry or at a relevant authority
  • Extensive regulatory knowledge in the area of pharmaceutical products within the EU
  • In depth knowledge and a thorough understanding of EU pharmaceutical legislation
  • Fluent English language skills
  • 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.

Apply online now

How to get that job Tips for applicants

Extensive and with first-rate support Benefits

Work needs to pay off - both in terms of money and satisfaction. To ensure our employees enjoy working here and work well and safely, we offer a wide range of employee benefits.

Your Contact Ulf Kaiser Human Resources Manager -2944

Berlin-Chemie AG Glienicker Weg 125
12489 Berlin
Phone -3600

Reference: 614988283