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I am a goal oriented manager with extensive experience in global governmental, public, corporate and regulatory affairs management in several sectors (food, feed and biotechnology). My skills are based on a very strong scientific research background and substantial international experiences. 

Analytical, adaptive and easy to engage with

Experiences

Current Experience

  • Regulatory Affairs Manager


    Since December 2015
    Regulatory Affairs

    • Global Regulatory Affairs Manager responsible for applications in the Food, Feed and Biotechnology field

    • Food/Feed Improvement Agents safety assessments (eg. EFSA, FDA, FSANZ, Cofepris, Anvisa, MoH China, FSA, HealthCanada)

    • Follow global regulatory evolutions and cross-links with other regulations (eg REACH, novel food) 

    • Governmental affairs, Public affairs and Corporate Affairs management

    • Management and procurement of independent scientific research

    • Provide regulatory advices/support/guidance/coaching to business units and QA/QC

    • Participate in international trade associations (AMFEP, FEDIMA for both Chair working groups)

Past Experience

  • Regulatory Affairs Specialist, Biotechnology

    April 2013 --- December 2015
    Food Safety

  • Project Manager, fresh produce imports

    January 2010 --- January 2011
    Market access

  • Project Manager, Risk Analysis

    January 2008 --- January 2010
    Risk Assessment

  • Data manager

    January 2007 --- January 2008
    Editing

  • Relocation and temporary positions

    January 2007 --- January 2007
    Standard Operating Procedure

  • Scientist, Post-Doctoral researcher

    January 2004 --- January 2006
    Project Planning

  • Scientist, Post-Doctoral researcher

    January 2004 --- January 2004
    Presentations

  • PhD Student

    January 2000 --- January 2004
    Project Planning

Personality

Self Assessment :
Analytical thinkingKindnessProactivityProblem solvingResiliencySelf-confidenceSelf-disciplineSociabilityStrategic thinkingOptimismInterest in knowledgeAdaptabilityAssertivenessCollaborationCritical thinkingCuriosityEfficiencyFlexibilityIndependenceTrust

Knowledge

Self Assessment :
Biochemistry Cell biology Negotiation R&D Scientific writingAllergy and immunologyAnimal trialBiochemistryBioinformaticsBiomarkersBiotechnologyCell biologyChemistryData AnalysisData ManagementDNADNA sequencingEMAEnglishEnzyme-linked immunosorbent assay (ELISA)FDAGenetic polymorphismGeneticsGood Laboratory Practice (GLP)Laboratory study designMarketing approvalMarket accessMicrobiologyMolecular & Cellular Biologymolecular biologyMolecular CloningNegotiationOxidative stressPCRPowerPointProtocolProject ManagementR&DRegistration of the productRegulatory affairsRegulatory RequirementsRegulatory StrategiesRegulatory submissionsResearch GovernanceRT-PCRSafety trialsScientific WritingScientific methodologySOPStrategic PlanningTeam LeadershipTechnical reportsTransfectionUnderstand how results translate to practiceUnderstand levels of research evidenceUnderstanding of regulatory guidelinesValidationVerificationWestern BlottingWriting Study Procedures and SOPs
LinkedIn Assessment :
AgrochemicalsResearchData AnalysisPublic SpeakingTeam LeadershipCell biologyRegulatory PolicySustainable AgricultureAgricultural PolicyLife SciencesmanagementProject ManagementPrecision AgricultureBiotechnologyRegulatory affairsRegulatory RequirementsGlobal Regulatory ComplianceLifesciencesRegulatory submissionsEnvironmental Impact Assessmentmolecular biologyBiochemistryAnalysisMicrobiologyInternational RelationsGeneticsProject PlanningTeam ManagementMicrosoft ExcelMolecular geneticsBioinformaticsGenomicsStakeholder ManagementStakeholder EngagementEditingAgricultureAgribusinessRisk AssessmentCrop ProtectionCustomer RelationsMicrosoft OfficeIntercultural CommunicationProject CoordinationscienceOrganizational EffectivenessLanguagesAuditing

Skills and Expertise

Self Assessment :
Analyze data Control data Create SOPs Guide students Develop protocols Interpret data Molecular Diagnostics Report data Technology research Use content management systems Write papersAdjust methodsAdjust processes Adjust processes and methodsApprove monitoring reportsArchive study documentsAssess site feasibilityAssign activitiesCoachCoach staffCommunicate with investigatorConduct literature searchesConduct research at universitiesConduct university research Control datacoordinating research projectsCreate standard operating procedure (SOP)Data analysisData miningData verificationDesign protocolDevelop regulatory strategyDirect co-workersEnsure data consistencyEnsure data integrityEvaluate protocolsExecute scientific projectsExtrapolate dataGenerate regulatory submissions General office managementInteract with CROslifescienceLiaise with research teamManage study supplyManuscript preparation and reviewMarket approvalManuscript reviewObserve trends in dataOperate research equipmentOral presentationOrganise meetingsPrepare internal auditsPrepare final reportPreparing referral lettersPresent data at congressPromotional materialsProtocol managementProvide benefit risk assessmentProvide trainingPublication of articlesPublish scientific projectsRegulatory documentationRegulatory submissionsReport dataReport study conclusionsResearch at universitiesReview monitoring reportsReview study protocolsUse content management systemsWrite papersWrite protocolsWritten presentation

Education

  • PhD in Phytopathology / Plant-Microbe Interaction from Universiteit Utrecht in 2004
  • MSc in Biology from University of Utrecht in 2000

Training and Certification

  • Environmental risk assessment of GM crops in 2014 Training
  • Social media training in 2014 Training
  • Strength finder in 2014 Training
  • Developing the strategic thinking skill and seeing the big picture in 2013 Training
  • World Trade Organisation and Sanitary and Phytosanitary (SPS) agreement in 2010 Training
  • Project Management in 2009 Training
  • Implementing & Auditing Quality Management Systems, Leading Management System Audit Teams (RABQSA International) in 2011 Certification
  • Resilience and stress relief in 2009 Certification
  • Radioacticivty Health Physics level 4B (Techical University Delft) in 2000 Certification

Languages

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

Work Preferences

  • Locations I am interested in:
    Rhône, France
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Rhône, France

Others

Driving License
  • Yes

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