International Regulatory Affairs Specialist

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 medicinal products, medical devices and food supplements. Based on your excellent knowledge and experience, you will conduct all necessary activities to acquire and maintain authorisations, registrations and certifications for our OTC products in different countries. As part of an international team you will be in close contact with colleagues in the countries, at our Regional headquarters in Berlin and other companies of the Menarini Group.

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 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;
Training and mentoring of local Marketing colleagues in the countries regarding media campaigns;
Analysing the market and competitor situation in the different countries and contributing to marketing plans for the OTC portfolio.

The offered position is limited for 2 years.

What sets you apart

University degree in pharmacy, chemistry or a comparable qualification in natural science;
First professional experience in the field of regulatory affairs in the pharmaceutical industry or at a relevant authority;
Regulatory knowledge in the area of OTC products, ideally in an international context;
Knowledge and understanding of the EU and non-EU pharmaceutical legislation;
Strong social skills in working with internal and external business partners;
Fluent English (Advanced level C);
Very good knowledge of MS Office.

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