Regulatory Affairs Administrator

For one of our client based in Brussels, we are looking for a Regulatory Affairs Administrator

  • Do you have a first experience in the Regulatory Affairs?

  • Are you able to work independently in a multi-cultural environment?

Then this might be the ideal job for you! Don't hesitate, and apply as soon as you can!

Job Description 

The Regulatory Affairs Administrator operates within the “Regulatory Affairs” (RA) Unit.

Responsibilities 
  • Prepare, handle, distribute and file submissions to national Competent Authorities, Central/ Local Ethics committees throughout the European continent.

  • Work according to standard operating procedures, European Directives and applicable country legislation

  • Develop expertise on assigned territories and general clinical trial environment.

  • Contribute to building and improving internal processes

  • Document management, including maintenance of working paper and electronic files and tracking of regulatory documentation within the E-TMF

  • Interaction with the internal clinical teams, regulators and scientific network

Profile 
  • Minimum Bachelor Degree / Graduate (level A1) in administration or science oriented courses
  • Experience in Regulatory Affairs related to clinical trials environment required (CRO or university/ hospital or pharmaceutical industry)
  • Proficient verbal and written English, other Member State language is an asset
  • Proficient in Word, Excel & PowerPoint, skills in SharePoint are an asset
  • Ability to cope with and meet tight timelines when required
  • Able to manage multiple tasks at the same time
  • Able to work independently as well as part of a team
  • Demonstrated good organization, communication and time-management skills
  • Excellent attention to detail and accuracy

 

Contact Information 

Interested? Don’t hesitate to contact Lindsay Bousmanne – Talent Acquisition at Valesta - Phone: 02 588 16 01 – Lindsay.bousmanne@valesta.com

Application form : Regulatory Affairs Administrator

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