Regulatory Affairs Manager | Belgium

Are you bitten by Regulatory Affairs? We are hiring a Regulatory affairs Manager for an innovative pharmaceutical company in Brussels!

You will oversee the planning & follow-up off all Regulatory activities for dedicated products and assure that these products are in accordance with the pharmaceutical laws.

Responsibilities:

• Preparation and submission of a marketing authorisation dossier for the Belgian and Luxemburg authorities
• The follow-up of this submission by having regular contacts with the authorities and manufacturers/dossier supplier
• Coordinating extra studies required for the registration files
• Management of the approved documents and taking care of a correct and timely communication with regards to new or changed data of dossiers
• Monitor and implement changes in the Regulatory environment: registration file compliance, renewals and authorisations
• Responsible for follow-up of all legislation related to medicinal products and non-medicinal products
   

Profile:

• Master’s degree in pharmaceutical, biotechnology or chemical sciences.
• 3 -5 years’ experience in RA Management.
• Dutch and English a must - French is a plus.
• Autonomous and assume responsibilities.
• Ability to handle multiple projects.