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

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 qualities:

In addition to our corporate STAR-values (Success-driven, Team-oriented, Adaptable and Respectful), your personal qualities include:

• 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
• Preferably fluent in Arabic language, both spoken and written

We offer:

• A challenging and diversified job
• Good career opportunities
• Inspiring work climate, in a truly international environment
• Attractive remuneration.