Regulatory Affairs Hoogstraten, Belgium
Since April 2013
Registration of veterinary pharmaceuticals, herbal products, feed addtives / supplements in cosmetics and detergents. 1. Submitting new scientific files (Clinical Veterinary part, Analytical CMC part, Ecotox / SDS, packaging&labeling and Legalized Certificates) to the autorities of Latin-American countries to register the pharmaceuticals. 2. Submitting renewals, to keep the products registered in the countries. 3. Submitting variations in order to keep the registrations up-to-date and conform what is manufactured,...For example: change formulation / composition, add package sizes, add target species,...
Liaise with the local authorities and the customers is an important part of the job. Preparing artwork according to the local guidelines and gathering samples according to the guidelines for analyses in authority laboratories.
*3 years expercience in Latin-American region: Mexico, RTCA-COMIECO (Costa Rica, Nicaragua, Honduras,...)countries, Dominican Republic, Brazil, ANDINO-CAN countries (Peru, Ecuador, Colombia), Venzuela, Uruguay & Chili
*2 years Asian countries: ASEAN (Philippines, Thailand, Myanmar, Vietnam, Malaysia,...) and non-ASEAN: Taiwan, Sri Lanka, Bangladesh & Pakistan.
*2 years of Eurasian Countries: Eurasian Custom's Union (Russia-Belarus-Kazakhstan-Armenia) and NIS (Uzbekistan - Georgië - Azerbaidjzan).
*1 year of Experience in non-EU European countries like Albania, Serbia, Kosovo and Ukrain.
Cell Manipulation Technologist - Scientist
September 2007 --- September 2012
Investigating T- and B-cell responses in large-scale vaccine trials....HepB booster, Human Papillomavirus, Varicella Zoster Virus, MS, HIV, ... Used laboratory techniques: cell culture / cell harvesting, automated cell counts, Flow Cytometry (FACS), Magnetic Cell Separation, ELISA, ELISPOT, Cell Transplant in Experimental Mouse Model, Bioluminescence in Experimental Mouse Model, Whole blood processing (PBMC),...
AdaptabilityApproachabilityAssertivenessAttention to detailCharmCollaborationCritical thinkingWillingness to compromiseStrategic thinkingSelf-disclosureResult OrientedSociabilityService orientedSelf-discipline
Animal models Cell biology Labtechnician Medical devices R&D Scientific writing Phase IAllergy and immunologyActions and modes of action of human physiologyActions and modes of action of drugs in the human speciesAnimal HealthAnimal trialAnimal ModelsCell CultureCell Based AssaysCMC Regulatory AffairsClinical trialsDrug regulatory authoritiesDrug safety assessmentELISAEnglishEnzyme-linked immunosorbent assay (ELISA)Enzyme AssaysEthics submission and approval processFlow CytometryFluorescent microscopyImmunohistochemistryImmunofluorescenceImmunocytochemistry (ICC)ICH guidelinesNeuroscienceNeurologyoncologyWriting Study Procedures and SOPsVeterinary MedicineVaccinesUnderstanding of regulatory guidelinesTissue CultureStem cell researchSocial SkillsSocial MediaSchizophreniaSAPRegulatory submissionsRegulatory StrategiesRegulatory RequirementsRegulatory ComplianceRegulatory affairsR&DPsychiatryProduct designPreclinical regulations and practicesPre-clinical researchPharmacovigilancePharmaceutical ResearchPharmaceutical salesPharmaceutical SciencesPCRPatient Follow UpPatient recruitmentMultilingualMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft ProjectMicrosoft WordMolecular & Cellular BiologyMedical affairsMedical consulting
Skills and Expertise
Build the CMC development plan Create SOPs Analyze data Develop clinical trial protocols Develop protocols Guide students Interact with physicians Interpret data Lab scale batches Monitor a clinical study Search literature on clinical trialsAdministrative supportAlzheimerAssist with experimentsAssist with proceduresAssist study siteAssign activitiesAttend seminars, courses and meetings within and outside the companyAttend investigator meetingAssist with routine testsbudgeting of R&D activitiesCalculate timelines for conducting and completing the trialCell cultureChemistry Manufacturing and Controls (CMC) activitiesClinical data collectionConduct literature searchesConduct animal studiesComplete study proceduresConduct research at universitiesConduct site initiationDevelop regulatory strategyDevelop study timelinesDevelop supply strategyDistribute study documentsDocument data reporting systemsEvaluate stability data Evaluate stability data and impurity identification/synthesisExecute scientific projectsGenerate regulatory submissions Guide studentsInteract with regulatory stakeholdersLate-stage regulatory filing (MAA, BLA)Liaise with doctors and other professionals throughout the studyManage regulatory activitiesPrepare regulatory documentsPresent clinical resultsRegulatory submissionsRegulatory documentationSubmit regulatory applicationsWriting regulatory documents
Master in Biomedische wetenschappen / Biomedical sciences from Universiteit Antwerpen in 2005
in Wetenschappen-Wiskunde from Lyceum Deurne - Waterbaan in 2001
Expert has 1 publications (Will be avalible with full profile)