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Regulatory Affairs

Regulatory Affairs Officer

The RA Officer is responsible for initiating, submitting and following up registration dossiers of new products/line extensions as well as maintaining the existing product licenses according to the current legislation. He/she keeps product leaflets and packaging material updated according to the legal requirements. He/she is responsible for the Submission of Periodic Safety Update Reports to the Health Authorities in Belgium and the creation of price and reimbursement files.

Requirements

  • Scientific degree
  • Experience in and / or full understanding of pharmaceutical regulations
  • Knowledge of Belgian and European legislation on medical products
  • Ability to engage regulators in scientific discussions
  • Excellent oral and written communication skills
  • Detail-oriented
  • Fluent in Dutch & English
  • Teamplayer
  • Pro-active, enthusiasm, keeping track of timelines

                             

Regulatory Affairs Manager

The RA Manager is responsible for initiating, submitting and following up registration dossiers of new products/line extensions as well as maintaining the existing product licenses according to the current legislation. He/she keeps product leaflets and packaging material updated according to the legal requirements. He/she is responsible for the Submission of Periodic Safety Update Reports to the Health Authorities in Belgium and the creation of price and reimbursement files.

Requirements

  • Scientific degree
  • At least 5 years of experience in and / or full understanding of pharmaceutical regulations
  • Knowledge of Belgian and European legislation on medical products
  • Ability to engage regulators in scientific discussions
  • Excellent oral and written communication skills
  • Detail-oriented
  • Fluent in Dutch & English
  • Teamplayer
  • People Management
  • Pro-active, enthusiasm, keeping track of timelines