For Astellas Pharma International, the International Marketing & Sales organisation in Leiderdorp, the Netherlands, we are looking for a Regulatory Affairs Manager (full time). Astellas Pharma International is present in Central and Eastern Europe, including the Baltic States and the Balkan countries, as well as the Near & Middle East, Africa and some other selected countries. 

The job:

In this role you are responsible for preparing, composing, submitting, defending and coordinating Marketing Authorization Applications (MAA) files and its belonging variations, renewals and other submissions in close cooperation with Regulatory Affairs Europe and the representing agent Regulatory Affairs contact. You will participate in regular cross Sectional meetings in Regulatory Affairs, meetings with the management of the relevant region(s) of the International Department and meetings with the representing agents. 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.

Your personal qualifications:

• Academic qualifications preferably as a pharmacist, chemist or (medical) biologist
• At least 2-3 years experience with regulatory affairs activities in the pharmaceutical industry
• Experience in working in multidisciplinary teams
• Good communication and writing skills
• Preferably good knowledge of the regulatory rules, guidances and institutes in the territory
• Fluent in English, both spoken and written

We offer:

• A challenging and diversified job
• Good career opportunities
• Inspiring work climate
• Attractive remuneration.