International Regulatory Affairs Manager (m/f/d)

10115 Berlin
29.01.2019

Daten dieser Anzeige

Job-ID: 009535722
International Regulatory Affairs Manager (m/f/d)

BERLIN-CHEMIE AG

Germany

https://careers.berlin-chemie.de/stellenangebote/jobentrypage?StellenID=43418&TrackingID=3&utm_source=jobware&utm_medium=stellenanzeige&utm_campaign=43418_International+Regulatory+Affairs+Manager+%28m%2Ff%2Fd%29&utm_content=button_bewerben

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.

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 Regulatory Affairs Career level Experienced professionals Entry level with immediate effect Fixed-term contract Permanent Working time Full-time Entry level with immediate effect Fixed-term contract Permanent Working time Full-time Your tasks 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. Your profile 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. Apply online now 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 careers.berlin-chemie.de

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Rechts- & Steuerwesen

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Vollzeit

10115 Berlin