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.
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.