Regulatory Affairs Administrator

For one of our clients located in Brussels, we are looking for an enthusiastic RA Administrator.

  • Do you have a university degree related to life sciences?
  • Do you have a first experience in Regulatory Affairs related to clinical trials environment (CRO or university/ hospital or pharmaceutical industry)
  • Are you fluent in English?

Then, you might be the candidate that we are looking for.

Job Description 

As RA Administrator, you operate within the “Regulatory Affairs” (RA) Unit.

Responsibilities 
  • You prepare, handle, distribute and file submissions to national Competent Authorities, Central/Local Ethics committees throughout the European continent.
  • You work according to standard operating procedures, European Directives and applicable country legislation.
  • You develop expertise on assigned territories and general clinical trial environment.
  • You contribute to building and improving internal processes.
  • You manage documentation, including maintenance of working paper and electronic files and tracking of regulatory documentation within the E-TMF.
  • You interact with the internal clinical teams, regulators and scientific network.

Responsibilities and career opportunities are adapted depending on the candidate's skills.

Profile 
  • You have a university degree related to life sciences.
  • You have a first experience in Regulatory Affairs related to clinical trials environment (CRO or university/ hospital or pharmaceutical industry).
  • You are fluent in English (verbal and written). Any other language is an asset. 
  • You are proficient in Word, Excel & PowerPoint, skills in SharePoint are an asset.
  • You have the ability to cope with and meet tight timelines when required.
  • You are able to manage multiple tasks at the same time.
  • You are able to work independently as well as part of a team.
  • You demonstrate good organization, communication and time-management skills.
  • You pay attention to details.

 

Contact Information 

Amandine Planche
+32 10 68 53 30
amandine.planche@valesta.com

Application form : Regulatory Affairs Administrator

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