Regulatory Affairs Administrator

2 jours restants

mercredi 21 mars 2018
Date limite
samedi 21 avril 2018
Carine Steurs
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Regulatory Affairs Administrator Organisation description:

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

Job description:

Main responsibilities Including but not limited to:

  • Sets the administrative frame for adequate filing and tracking of the Regulatory Affairs responsibilities.
  • Set-up and maintains Regulatory Affairs (RA) database & tracking
  • Ensures adequate administrative preparation & follow-up of clinical trial applications (CTAs) and relevant documents in the countries allocated.
  • Sets the organizational structure of the new project in the available tracking, filing systems at the start of the study
  • Adapts master cover/submission letters to CA(s), EC(s), and Principal Investigators (PIs) from master study documents to local requirements.
  • Adapts/submits country specific xml files following master XML prepared by RAM and processes with submission and tracking of approvals on allocated countries
  • Ensures appropriate follow-up of authorizations by filing approvals and related communication/ documents for amendments and declaring the EoR/ EoT
  • 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 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
  • Proficient verbal and written English, other Member State language is an asset

A temporary mission (maternity leave) within a highly stimulating, professional & friendly atmosphere in an international environment Possibility to grow to other RA opportunities within XPE (IF future opportunities, IF pharmacist/scientific background AND IF very good command of ENGLISH and FRENCH and/or DUTCH)

XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713

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