Job Description

Novellas Healthcare

Recruiter Luc Decat
Belgium|Pharmaceuticals|-

Regulatory Affairs Manager | Brussels Area

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.

 

 

 

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