Regulatory Affairs Manager

De organisatie

For the International Marketing & Sales organization in the Netherlands, we are looking for a Regulatory Affairs Manager.

Functieomschrijving

In this role you will assess registration activities for relevant products in relevant regions by preparing a Regulatory International Plan and ensure register ability and maintenance of existing registrations. In close cooperation with Regulatory Affairs Europe and the representing agent Regulatory Affairs contact you are responsible for preparing, composing, submitting, defending and coordinating Marketing Authorization Applications (MAA) files and its belonging variations, renewals and other submissions.

Functie-eisen

Academic qualifications preferably as a pharmacist, chemist or (medical) biologist
At least2-3 years experience with regulatory affairs activities in the pharmaceutical industry
Experience in working in multidisciplinary teams
Good communication and writing skills
Accuracy
Good organisation/co-ordination of work in a complex setting.
Preferably good knowledge of the regulatory rules, guidances and institutes in the territory
Fluent in English language, both spoken and written
Fluency in Arabic language, both spoken and written is an advantage

De organisatie biedt

For more information please contact Annet Braakman at annetbraakman@perselectief.nl or by phone +31 655 321 637