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Summary

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Experiences

Current Experience

  • Sr Manager Global Reg. Affairs, Early Development
    Since April 2012

Past Experience

  • Expert Scientist Clinical Reg. Affairs
    February 2008 --- March 2012

  • Sr Associate European Reg. Affairs
    March 2006 --- February 2008

  • Regulatory Affairs Associate
    January 2000 --- January 2006

  • Business Development Associate
    January 1999 --- January 2000

Personality

Self Assessment :
AdaptabilityStrategic thinkingService orientedSelf-disciplineResiliencyIndependenceFlexibilityCritical thinkingCoordinationCollaborationAttention to detailAnalytical thinkingTrust

Knowledge

Self Assessment :
BiotechnologyClinical DevelopmentClinical study reportsDrug development processDrug regulatory authoritiesDrug Safety and PharmacovigilanceEarly development stageEMAEnglishFDAINDIMPDInterpret clinical trial resultsIt skillsMarketing Authorisation Application (MAA)Pharmaceutical IndustryPharmacovigilancePowerPointRegulatory affairsRegulatory RequirementsRegulatory StrategiesRegulatory submissionsScientific WritingUnderstanding of regulatory guidelinesVaccines
LinkedIn Assessment :
Regulatory affairsVaccinesInfluenzaRegulatory submissionsPharmaceutical IndustryClinical StrategyRegulatory InteractionsStudy ReportsProtocol ReviewFrenchdutchEnglishRegulatory RequirementsICH-GCPClinical DevelopmentClinical trialsMedical writingBiopharmaceuticalsPharmacovigilance

Skills and Expertise

Self Assessment :
Interpret data Report dataCollaborate with project teamDevelop regulatory strategyEvaluate protocolsGenerate regulatory submissions Manuscript reviewPrepare regulatory documentsRegulatory documentationRegulatory submissionsReview clinical study reportsReview data interpretationReview study protocolsWriting regulatory documents

Education

  • M.Sc. in Biomedical Technology from Université catholique de Louvain in 1993
  • Baccalaureat D in Science from Lycée Français Vincent Van Gogh, The Hague (NL) in 1986

Training and Certification

  • MSc Biomedical Technology in 1993 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
Dutch
Native
English
Full Proficiency
German
Elementary Proficiency

Area / Region

Overijse, Belgique

Others

Driving License
  • Yes