Regulatory Affairs / Administrative Assistant

For one of our clients in the area of Brussel (South-West), we are looking for a Regulatory Affairs Assistant with great language skills.  This for a period of 6 months.

  • Do you have a first experience in clinical research?
  • Are you fluent in English, French and Dutch?
  • Are you familiar with electronic tracking systems?

Then send me your CV as soon as possible!


Marketing Authorizations

  • Administrative support in compiling, submitting and closing variations.
  • Review of translations (English-French-Dutch-German?).
  • Filing and Archiving of regulatory dossiers/files/documents according to the requirements of the company -Tp, RecPoint (backlog), GPRS (to start)-
  • Tracking: 4 eye review in GPRS
  • Searching documents in GPRS (market access support)
  • SmPC/PL distribution
  • ALPIN / Proofware (text/proofs verification tool) 

Clinical Trial Applications

  • Administrative support in compiling and submitting initial CTA and amendments, notification of DIL,….
  • Tracking, Filing and Archiving of dossiers/files/documents according to the company requirements 
  • Preferably a first experience in clinical research or a similar position
  • Fluent in Dutch, French, English.  If you know German, that would be even better.
  • Excellent administrative skills: detail oriented, good time management, conscientious, ...
Contact Information 

Nele Daems
015 21 11 04

Application form : Regulatory Affairs / Administrative Assistant

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