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Summary

skilled life science professional with medical and scientific background.

leading regulatory writer for eu & us submissions, experienced in (e)ctd and lifecycle management.

specialised in regulatory Strategy for early Clinical Development.

Experiences

Current Experience

  • Associate Director Regulatory Affairs


    Since June 2016

  • Regulatory Affairs Manager


    Since July 2012

Past Experience

  • Senior Regulatory Affairs Associate

    June 2010 --- June 2012

  • Medical Writer

    January 2010 --- June 2010

  • Medical and Scientific Writer

    September 2007 --- January 2010

  • PhD in Medicine

    July 2003 --- September 2007

Knowledge

LinkedIn Assessment :
Regulatory affairsLife ScienceseCTDINDClinical DevelopmentDocument ManagementClinicalprotocol developmentWritingManuscriptsClinical trialsImmunologyBiotechnologyClinical researchPublicationsMedical writingNeuroscienceFDARegulatory submissionsData ManagementMicrosoft OfficeEnglishInformaticspharmacologyRegulatory StrategyICH-GCPDrug DiscoveryResearchBiopharmaceuticalsNeurologyScientific WritingLifesciencesScience CommunicationManuscriptRegulatory RequirementsDrug DevelopmentGCPPharmaceutical IndustryAntibodiesoncologyPharmacovigilanceBiologicsInfectious diseasesVaccinesCROToxicologyMedical affairsClinical monitoringSOPPharmacokinetics

Education

  • Ghent University Hospital - Dpt. of Neurology in from Ph.D. in Medicine in 2008
  • Master of Science (MSc) Biology in from Ghent University in 2003

Area / Region

Ghent, België

Others

Driving License
  • Yes

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