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Summary

Regulatory affairs, specifically new applications. Administrative coördinator

Experiences

Current Experience

  • Dossier Manager for applications new medicinal products
    Since September 2009
    At FAMHP I am responsible for the validation and dossier management of applications for new medicines. In our team, we evaluate if a new medicine can be authorised in Belgium following a positive evaluation in terms of quality, safety and efficacy, starting from an acceptable legal base and an acceptable content of the dossier ~ European guidelines. Most of these applications are procedures in which different Member States of the EEA are concerned.

Past Experience

  • Regulatory Affairs
    April 2007 --- September 2009

  • Nurse
    January 2006 --- January 2007

  • Nurse at Neonatal Intensive Care Unit (NICU )
    January 2005 --- January 2006

  • Nurse at Intensive Care Unit (adults)
    January 2004 --- January 2005

Personality

Self Assessment :
Analytical thinkingAttention to detailCollaborationCoordinationEfficiencyOptimismOrganizationProblem solvingProactivity

Knowledge

Self Assessment :
Drug regulatory authoritiesEnglishMarketing Authorisation Application (MAA)Microsoft OfficeNeurologySOPValidation

Education

  • Bachelor's degree in Verpleegkundige pediatrie from Hogeschool Gent in 2004

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
French
Professional Proficiency
English
Professional Proficiency

Work Preferences

  • Locations I am interested in:
    Oost-Vlaanderen, België
  • Work From Home:
    Yes, 3 to 5 days per week
  • Work Regime:
    BrightOwl freelancer
  • International:
    No

Area / Region

Lierde-Sainte-Marie, Lierde, België

Others

Driving License
  • Yes