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(Junior) Regulatory Affairs Administrator (Clinical Trial Applications)

For one of our clients located in the east of Brussels, we are looking for an enthusiastic (Junior) Regulatory Affairs Administrator to work on Clinical Trial Applications.

Responsibilities
  • You set the administrative frame for adequate filing and tracking of the Regulatory Affairs responsibilities.
  • You set-up and maintain Regulatory Affairs (RA) database & tracking
  • You ensure adequate administrative preparation & follow-up of clinical trial applications (CTAs) and relevant documents in the countries allocated.
  • You set the organizational structure of the new project in the available tracking, filing systems at the start of the study
  • You adapt master cover/submission letters to CA(s), EC(s), and Principal Investigators (PIs) from master study documents to local requirements.
  • You adapt/submit country specific xml files following master XML prepared by RAM and processes with submission and tracking of approvals on allocated countries
  • You ensure appropriate follow-up of authorizations by filing approvals and related communication/documents for amendments and declaring the EoR/ EoT

Career opportunities evolve in view of the individual skills of the employee.

Requirements
  • You have a University degree in administration or science oriented courses
  • You have a first experience as a CTA with experience in supporting start-up tasks or you have a first experience in Regulatory Affairs related to clinical trials environment required (CRO or university/ hospital or pharmaceutical industry)
  • 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 an excellent attention to detail and accuracy
  • You are fluent in English