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Experiences

Current Experience

  • Registration Manager Europe

    Brussels, Belgium
    Since November 2015

    responsible for all regulatory activities related to the company's products at different stages of their lifecycle. negotiations with authorithies

    Responsible for all regulatory activities related to the company's products at different stages of their lifecycle. Negotiations with authorithies

Past Experience

  • Junior Registration Manager Brussels, Belgium

    March 2014 --- October 2015

    responsible for all activities associated with registration of new products

Personality

Self Assessment :
AdaptabilityAnalytical thinkingApproachabilityAttention to detailCollaborationCommunicativeCoordinationCritical thinkingDiligenceEfficiencyFlexibilityIndependenceOptimismOrientationPerspectiveProactivityProblem solvingReaction to stressResult OrientedStrategic thinkingTrustWillingness to compromise

Knowledge

Self Assessment :
Animal models Biochemistry Cell biology Negotiation R&D Scientific writingAnimal ModelsAnimal trialApplicationsBiologyBiomedical SciencesBiotechnologieBiotechnologyCell biologyCell CultureCommunication SkillsComplianceCompliance with regulationsContinuous ImprovementDNADNA extractionDNA sequencingElectrophoresisEnglishFluorescence MicroscopyGeneticsHistologyLife SciencesMicroscopyMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMolecular & Cellular BiologyMolecular CloningNegotiationOutlookOxidative stressPCRProject PlanningRegulatory affairsRegistration of the productRegulatory ComplianceRegulatory StrategiesRisk AssessmentRisk ManagementTime Management

Skills and Expertise

Self Assessment :
Develop protocols Guide students Interpret data Report data Search literature on clinical trials Write papers Write protocolsAdjust methodsAdjust processes Advise on strategyArchive documentationAssemble regulatory applicationsCell cultureCollect dataCommunicationConduct literature searchesCoordinationDesign studyDesign tracking systemDevelop regulatory strategyDevelop study timelinesInteract with regulatory stakeholdersInteract with statisticiansMaintain strong relationshipsManage complexityManage risksNegotiationOral presentationOrganise meetingsPrepare regulatory documentsPrepare responses to health authority queriesR&DRead medical literature to maintain current awareness and knowledgeRegulatory documentationRegulatory submissionsReport study conclusionsReport technical problemsReview data interpretationReview experimental plansStorytellingSubmit regulatory applicationsUse fluorescence microscopyUse laboratory techniquesUse western blotting techniqueWork cross-functionallyWork under specific instructionsWrite documentsWrite final reportsWriting regulatory documentsWritten presentation

Education

  • PhD in Biomedicine from Katholieke Universiteit Leuven in 2014
  • Master in Histopathology from Kieve Taras Shevchenko National Univercity (Kiev, Ukraine) in 2007

Training and Certification

  • Project Management in 2015 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    English
    Full Proficiency
    Russian
    Native
    Dutch
    Professional Proficiency
    French
    Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Regulatory Affairs Manager
  • Locations I am interested in:
    Antwerp, Belgium Mechelen, Belgium
  • Work From Home:
    Yes, 1 to 5 days per week
  • Work Regime:
    Permanent position :    80-100% FTE
  • International:
    Yes

Area / Region

Antwerp, Belgium

Others

Driving License
  • No

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