multidisciplinary Scientist with experience in biopharmaceutical insdustry (r&d and analytical approaches). Training in Regulatory Affairs, including pre-and post-Marketing authorization regulatory activities, Quality System management (qa/qc, cGMP/gcp/glp, qbd; Risk Management...), Analytical Method Validation and transfer, Pharmaceutical product licfecycle, Preclinical and Clinical studies), Medical Devices and Food supplements; project and team managements, reach, clp...
ph.d. in Bioengineering and agronomic sciences (Research in the field of Molecular Virology and Immunology, Cell Culture, cell Characterization and viral production and study of viral replication cycle).
Analytical thinkingAdaptabilityAssertivenessAttention to detailCollaborationCommunicativeCritical thinkingFlexibilityOptimismOrganizationProactivityProblem solving
Cell biology Biochemistry R&D Scientific writing21 CFR Part 11 Phase IAnalytical Method ValidationAnalytical methodsAnalytical proceduresAnalytical techniquesAseptic TechniquesBiochemistryBiological Drug DevelopmentBiologyBiopharmaceuticalsBiotechnologyBPFCAPACell biologyCell CultureCell SignalingcGMPCell Based AssaysChange ControlCharacterizationChromatographyClinical Data ManagementClinical pharmacologyClinical trialsCRFCurrent Good Manufacturing Practice (CGMP)Data AnalysisData entryData ManagementData ScienceDNADNA extractionDNA sequencingDrug regulatory authoritiesDrug Safety and PharmacovigilanceVirologyVeterinary MedicineValidationVaccinesTransfectionTranslationTechnology transferTechnology DevelopmentT cellsSDS-PAGEScientific WritingScientific methodologyScientific CommunicationsscienceRT-PCRRoot Cause Analysis (RCA)RNA isolationRisk ManagementRisk AssessmentResearchReport WritingRegulatory RequirementsRegulatory StrategiesRegulatory submissionsRegulatory ComplianceRegulatory affairsrecombinant DNA technologyreal-time PCRQuantitative PCR (qPCR)
Skills and Expertise
Analyze data Analytical skills Control data Interact with physicians Interact with nurses Report data Search literature on clinical trials Write protocols Write papersArchive documentationArchive study documentsAseptic processing Guide studentsAnalyze data/information to determine potential relationships.Analyze proteinAnswer, transfer and handle incoming calls as needed.Aseptic techniquesAssemble regulatory applicationsAttend seminarsAttend seminars, courses and meetings within and outside the companyCapture data on source documentsCell cultureCoachcollaborate in research projects at universitiesCollaborate with project teamCollect dataCollect patient forms and questionnairesConduct research at universitiesCreate clinical documentsData codingData entryData validationData verificationDesign protocolsDesign scientific experimentsDesign scientific projects (in biology)Design study documentsDevelop ICH/GCP compliant processesDevelop Quality Risk Management (QRM) initiativesEncode dataEnsure data consistencyEnsure data integrityExecute scientific projectsIdentify risksInteract with nursesInteract with statisticiansWritten presentationWrite final reportsWrite documentsConduct literature searchesManuscript preparationManuscript preparation and reviewOrganize scientific projects (in biology)Plan experimentsPlan work to meet objectives and deadlinesPresent data at congressProtocol managementRegulatory documentationRelease products
Ph.D. in Molecular Virolgy and Immunology from University of Liège-Gembloux Agro-Bio Tech in 2010
Diploma of Specialized Sutdies (D.E.S) in Biotechnologie in Biochemistry and Biotechnology from University of Liège-Gembloux Agro-Bio Tech in 2004
Training and Certification
Regulatory Affairs Manager in 2017 Certification