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!

Responsibilities 

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 
Profile 
  • 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
nele.daems@valesta.com
015 21 11 04

Application form : Regulatory Affairs / Administrative Assistant

Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.

I want to stay informed.

I would like to receive Valesta news, valuable insights into industry trends, career opportunities, trainings, and other helpful tips to find assignments that match my skills and interests. Click here to stay connected with Valesta.

Valesta is an expert in life science recruiting and project staffing.  The information you are submitting is important for us to respond to your assignment and contract needs. In compliance with the General Data Protection Regulation (EU) 2016/679) (“GDPR”), Valesta will process your personal data in accordance with our Privacy Policy. Valesta will safeguard your personal information and not disclose to any person unlawfully. As a staffing company, Valesta receives and processes your personal data for the following purpose: to take appropriate steps to find you an assignment with one of our clients and/or to finalise a contract with you.

Please note that Valesta does not wish to receive any data from you if you are under the age of eighteen (18) or data that is classified as Sensitive Data under the GDPR; this includes personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic/biometric/health-related data or data concerning a person's sex life/sexual orientation.

Please read our disclaimer.