International Regulatory Affairs Manager (m/f/d)

Einsatzort: Berlin

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 (m/f/d)

Site
Berlin
Specialist field
Drug Safety
Career level
Experienced professionals

Your tasks

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

To do so, you will evaluate the required regulatory activities and prepare the respective documentation as well as submission schedules under consideration of local provisions and laws of the various countries, also interacting with other stakeholders and concerned departments involved in the processes, to support and to guarantee that all the relevant activities performed appropriately and in time.

Furthermore, you will negotiate the necessary steps for acquiring and maintaining product authorizations, 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 regulations and Best Practice guidelines and ensure that this information flows smoothly within the company as well as with contract partners and licensors.

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 31/12/2022.

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 in an international context
  • in depth knowledge and a thorough understanding of the EU and non-EU pharmaceutical legislation
  • fluent English skills, knowledge of the Russian language is an advantage
  • very good knowledge of MS Office

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

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

030 6707-2944

Berlin-Chemie AG


Glienicker Weg 125
12489 Berlin
Phone 030 6707-3600