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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