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International Regulatory Affairs Manager (m/f/d)
Aktualität: 11.10.2021


11.10.2021, BERLIN-CHEMIE AG
International Regulatory Affairs Manager (m/f/d)
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.
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 Tips for applicants