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)
Specialist field Regulatory Affairs
Career level Experienced professionals
Entry level with immediate effect
Fixed-term contract Permanent
Working time Full-time
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.
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.