International Regulatory Affairs Manager - EU (m/f)
BERLIN-CHEMIE AG is an internationally expanding, research-based pharmaceutical company of the Italian MENARINI GROUP. Potent innovative preparations, professional marketing and intensive cooperation with doctors and patients form the basis of our success. Would you like to come on board and join us on our successful journey?
|Specialist field||Regulatory Affairs|
|Career level||Experienced professionals|
|Entry level||with immediate effect|
You are responsible for the acquisition and regulatory management of international marketing authorisations for pharmaceutical products. This involves conducting all necessary activities to maintain existing or acquire new authorisations, registrations and certifications in EU 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.
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 within the EU
- In depth knowledge and a thorough understanding of EU pharmaceutical legislation
- Fluent English language skills
- Very good knowledge of MS Office
- Willingness to engage in occasional international travel
Under Employer benefits, you will learn more about us as an employer.
For further questions please contact Mr. Kaiser.
Glienicker Weg 125