International Regulatory Affairs Manager

International Regulatory Affairs Manager

BERLIN-CHEMIE

Berlin, Germany

Within our International Regulatory Affairs & Drug Safety Department in Berlin, you will be responsible for the acquisition and regulatory management of international marketing authorisations of pharmaceutical products. Based on your excellent knowledge and experience, you will conduct all necessary activities to maintain existing or acquire new authorisations, registrations and certifications for our products in the Eastern European and CIS countries. As part of an international team you will be in close contact with our local colleagues in the countries and report to the respective Group Regulatory Affairs Manager.

These tasks inspire you

• Evaluating the required regulatory activities and preparing the respective documentation as well as submission schedules under consideration of local provisions and laws of the various countries
• Interacting with stakeholders and related departments to guarantee that all relevant activities are performed appropriately and in time
• Clarifying 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
• Preparing all regulatory activities in compliance with valid regulations and Best Practice guidelines
• Continuously monitoring and analysing all amendments to and updates of the relevant regulatory legislations, regulations and deadlines of the respective countries and acting as contact person for regulatory questions.

What sets you apart

• University degree in pharmacy, chemistry or a comparable qualification in natural science
• 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, ideally within the EAEU
• In depth knowledge and a thorough understanding of the EU and non-EU pharmaceutical legislation
• Strong social skills in working with internal and external business partners
• Fluent English skills, knowledge of the Russian language is an advantage
• Very good knowledge of MS Office

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