a multi-talented highly flexible team player with a strong scientific background, solid organizational, management and coordination abilities and a quick learning capacity. international experiences in france and new zealand have resulted in excellent verbal and written Communication Skills in several languages, strong ability to work under pressure, meeting deadlines, highly developed social skills as well as thinking "outside the box”. specialties: Project Planning, oral and written Presentations, Proofreading, Editing, management, information management, languages, computer skills, organizational abilities, quick learning capability, project coordination, Flexibility, strong ability to work under pressure and meeting deadlines, Regulatory Affairs eu and new zealand.
Regulatory Affairs Specialist, Biotechnology
Since April 2013
* obtain authorization approvals for Biotechnology derived products in europe in accordance with the european authorization procedures. * prepare, submit and manage high quality regulatory registration dossiers to the european Food Safety authority, in accordance with relevant european legislation (science liaison) * perform (environmental) risk assessments for genetically modified plant product approvals in emea * contribute to the development of regulatory strategies for individual products (maize, soybean, oilseed rape, cotton, sugarbeet) * prepare post market monitoring reports, including Literature Reviews * support Regulatory Compliance & stewardship throughout product life cycle for individual products * keep abreast of latest scientific and regulatory developments * obtain registrations and renewals or permits for genetically modified plant products in the eu Member of the environmental Risk Assessment working group @ europabio Member of the detection method working group @ europabio * Obtain authorization approvals for biotechnology derived products in Europe in accordance with the European authorization procedures. * Prepare, submit and manage high quality regulatory registration dossiers to the European Food Safety Authority, in accordance with relevant European legislation (science liaison) * Perform (environmental) risk assessments for genetically modified plant product approvals in EMEA * Contribute to the development of regulatory strategies for individual products (Maize, Soybean, Oilseed rape, Cotton, Sugarbeet) * prepare post market monitoring reports, including literature reviews * Support regulatory compliance & stewardship throughout product life cycle for individual products * Keep abreast of latest scientific and regulatory developments * Obtain registrations and renewals or permits for genetically modified plant products in the EU Member of the Environmental Risk Assessment Working Group @ EuropaBio Member of the Detection Method Working Group @ EuropaBio
Project Manager, fresh produce importsJanuary 2010 --- January 2011
key responsibilities: • develop, implement and review production pathways, regulatory documents, guidance documents, Risk Management proposals and official assurance proposals in accordance with international standards. • Project Management of Market access Applications and Regulatory Affairs. • coordinate/lead bilateral technical discussions with foreign authorities and participate in multilateral technical meetings. • provide Policy and technical advice. • liaise with overseas control authorities and international organisations. • liaise with interested parties such as government departments, other agencies and industry groups to facilitate wider trade. key achievements: • delivered completed Documentation for Market access of fresh produce from peru, south korea, india. • analysed new and existing pathways for fresh produce from china. • participated in the evaluation of new international standards. • delivered solutions for non-conformance interceptions at the border.
Project Manager, Risk AnalysisJanuary 2008 --- January 2010
key responsibilities: • coordinate and conduct risk Analysis, including project scoping, Planning, reporting, hazard identification, Risk Assessment and Risk Management. • analyse production pathways and pest impacts on Agriculture, forestry, horticulture and human Health. • allocate quarantine status for organisms intercepted at the border. • contribute to the development and review of risk Analysis policies, standards and processes according to international guidelines. key achievements: • delivered a risk Analysis for controversial imports from china well within allocated time, without being challenged by industry or exporting country. • contributed substantially to the risk Analysis of imports from the usa. • managed a colleague new to the risk Analysis group. • planned the yearly christmas outing for around 70 staff members.
Data managerJanuary 2007 --- January 2008
key responsibilities: • layout and mail merging of advertisements. • data production, adaptation and design. • Proofreading and Editing of advertisements. key achievements: • performed the production of a vast array of Marketing products. • the Health and safety commission.
Scientist, Post-Doctoral researcherJanuary 2004 --- January 2006
key responsibilities: • leading and performing scientific Research into the molecular mechanisms behind induced resistance in grapes. • leading and performing field trials to evaluate the effects of induced resistance in the grapes in the champagne area. • Project Planning and Budgeting. • Editing and peer-reviewing Publications. key achievements: • produced two articles in international scientific journals. • supervised two master students (in French).
PhD StudentJanuary 2000 --- January 2004
key responsibilities: • performing scientific Research into the transcriptomics, molecular pathway and knockout mutant Analysis of rhizobacteria-mediated induced systemic resistance in arabidopsis. • writing scientific Publications and giving international oral Presentations. • master Student supervision. • Project Planning. • maintaining international cooperation with syngenta ltd (usa) and a larger european cooperation. key achievements: • produced many articles in international scientific journals. • made several international poster Presentations and a presentation on a large international congress in new zealand. • wrote a thesis and successfully defended it in front of a commission of professors, resulting in a dr. grade. • supervised a master Student.
Analytical thinkingKindnessProactivityProblem solvingResiliencySelf-confidenceSelf-disciplineSociabilityStrategic thinkingOptimismInterest in knowledgeAdaptabilityAssertivenessCollaborationCritical thinkingCuriosityEfficiencyFlexibilityIndependenceTrust
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
Skills and Expertise
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
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