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Current Experience

  • Regulatory Affairs Manager Europe

    Since February 2011
    Project Management for Veterinary medicinal products and feed additives. this includes: - identification, science)" rel="nofollow">Protocol development and follow-up of the required regulatory studies (part iii and iv) - preparation of the dossier, submission and follow-up of the regulatory procedures (mrp, dcp, ...) for both vmps and feed additives - variations, etc… Project management for veterinary medicinal products and feed additives. This includes: - Identification, protocol development and follow-up of the required regulatory studies (Part III and IV) - Preparation of the dossier, submission and follow-up of the regulatory procedures (MRP, DCP, ...) for both VMPs and feed additives - Variations, etc…

Past Experience

  • Regulatory Affairs Manager

    July 2006 --- February 2011

  • Assistant

    October 2004 --- July 2006

  • Veterinarian France

    September 2003 --- June 2004

    large animal Veterinarian in bourgogne (france)


Self Assessment :
Analytical thinkingApproachabilityAttention to detailCollaborationCharmEfficiencyDiligenceIndependenceInterest in knowledgeResponsibilityResult OrientedService orientedTrustSelf-confidence


Self Assessment :
Animal HealthCMC Regulatory AffairsUnderstanding of regulatory guidelinesRegulatoryInternational Project ManagementProject CoordinationProject ManagementProject PlanningClinical researchPharmaceutical Research Animal models Biostatistics Scientific writingA rising single dose tolerance studyBioinformaticsClinical Data Management (CDM)Clinical DevelopmentClinical monitoringClinical pharmacologyClinical trial designClinical trial managementGood Clinical Practice (GCP)Good Clinical Practice Veterinary (GCPv)Good Laboratory Practice (GLP)Good Manufacturing Practice (GMP)managementMS ProjectPhases of clinical development (phase I to IV)Regulatory affairsRegulatory ComplianceRegulatory RequirementsRegulatory StrategiesRegulatory submissionsReport WritingTeamworkVeterinary MedicineWriting Study Procedures and SOPs
LinkedIn Assessment :
Veterinary MedicineRegulatory affairsVeterinaryClinical trialsPharmaceutical IndustryVaccinesProduct developmentscienceCoachingRegulatory submissionsPharmacovigilanceInfectious diseasesLifesciencesBiotechnologyGMP

Skills and Expertise

Self Assessment :
Analytical skills Monitor a clinical study Report data Technology research Write protocolsAdjust methodsAdjust processes Advise on strategyAssemble regulatory applicationsCalculate process efficiencyCalculate timelines for conducting and completing the trialCoachcollaborate in research projects at universitiesCollaborate with principal investigatorCollaborate with project teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Communicate effectively on different company levelsCommunicate with investigatorCoordinate projectsCreates a collaborative team environmentDevelop study budgetDevelop study timelinesDevelop clinical strategyIdentify market opportunitiesInterpret electrical schematicsInterpret dataInteract with regulatory stakeholdersInterpret analytical resultsInterpret research resultsLiaise with professionals in other divisions of the company as requiredMaintain strong relationshipsManage multiple projectsManage projects resourcesManage regulatory activitiesManage risksManage study budgetManage study supplymanaging a small teamNetworkproject managementProtocol managementRegulatory submissionsStudy-related documentsTranslate clinical research concepts into specific objectivesTranslate customer needs into analytical study proposal/protocolTranslate strategy into operational plansWork cross-functionally


  • Veterinary Medicine in Live Stock Animals from University of Ghent in 2003


BrightOwl Assessment:
Self Assessment:
Full Proficiency
Full Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Director Regulatory Affairs Regulatory Affairs Manager Regulatory Project Manager Program Manager (PMP & CSM) Clinical Project Manager (CPM) Project Manager Senior Project Manager (PM) Associate Director - Head of Preclinical Immunology - Bacterial Vaccines Clinical Development Consultant Clinical Research Consultant Lead Consultant Management Consultant Regulatory Affairs Consultant Senior Strategy Consultant Veterinary Clinical Manager
  • Positions I am NOT interested in:
    Account Executive Account Manager - Life Sciences
  • Locations I am interested in:
  • Work From Home:
    Yes, 1 to 2 days per week
  • Work Regime:
    BrightOwl freelancer :    60-80 Hours per week
  • International:

Area / Region

Munkzwalm, Belgium


Driving License
  • Yes

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