to cut a long Career short, after my phd Qualification at ghent University, in Pharmaceutical Sciences, i joined european life science industies where i have developped various experiences (14 years) for the whole drug product life, mainly r&d, Manufacturing, pre- and post-Marketing Regulatory Affairs:
- coordinating, and managing Research and development of new pharmaceutical products, according to ich good practices (GMP, glp, gcp) including clinical studies in africa (anti-malarial products) mainly ivory coast, mali, ghana, senegal, kenya, etc...
- coordinating, Planning and implementing the whole product manufacture development activities including Process development and Validation, analytical procedures, stability studies and Technology transfer to the production department.
- Planning and ensuring Regulatory Compliance from early Drug Development, in pre- and post-Marketing phases, and coordinating, implementing and follow-up all regulatory submissions, and ensuring all cross-functional actions with involved departments for cost-effective and early market entry.
- reviewing all Product Development documentations and writing the quality cmc regulatory Documentation mainly module 2 (quality overal summary) and module 3 of ctd as recommended by ich, for all regulatory submissions such as application for Clinical trials (impd) according to local requirements, application for Marketing authorization, responses to queries, variations, renewals, etc...).
- strong knowledge in global artwork (patient information and labelling) for global compliance with various country specifications; pre-clinical and clinical Drug Development.
- fluent in French, English and good dutch; loyal, pro-active autonomous Scientist with organizational and Time Management, team spirit, Problem-solving and results oriented skills.
Sr Consultant Manager CMC & RAMannheim, Germany
Since July 2015
coordinate and drive strategic/operational regulatory cmc for various project development for national and international markets, with regards to Pharmaceutical quality Documentation (ctd dossier), Clinical Documentation, preparation of gap Analysis, life cycle (renewals), variations site transfer for assigned projects and ensuring Regulatory Compliance.
Coordinate and drive strategic/operational Regulatory CMC for various project development for national and international markets, with regards to pharmaceutical quality documentation (CTD dossier), clinical documentation, preparation of gap analysis, life cycle (renewals), variations site transfer for assigned projects and ensuring regulatory compliance.
CMC & Regulatory Affairs manager Turnhout; BelgiumApril 2006 --- June 2011
managing all regulatory aspects including cmc and global Compliance with applied regulatoy requirements for all stages of product life cycle from r&d, design, Manufacturing, pre- & post- Marketing authorizations
Planning, coordinating, compiling and reviewing all regulatory submissions such as preparation & updating registration technical dossiers (ctd, eCTD) and investigational medicinal product dossier (impd) according to ich and country specific requirements.
ensuring follow-up of all regulatory process through direct contact with local representatives, distributors, regulatory agencies, and preparation of all additional regulatory submissions (responses to queries, variations, renewals, tenders, etc...) for timely market entry
Research Coordinator R&D formulation, CMC & Regulatory affairs Bornem; BelgiumApril 2002 --- March 2006
redaction of quality Documentation (cmc) for all regulatory submissions including to ich requirements
Problem solvingProactivityOptimismInnovative thinkingIndependenceFlexibilityEfficiencyCritical thinkingCoordinationCollaborationAttention to detailAnalytical thinkingApproachabilitySelf-confidenceAdaptabilityCommunicativeOrganizationResiliencyResult OrientedSelf-disciplineSociabilityStrategic thinkingPerspectiveCreative thinkingCompetitivenessAuthenticityResponsibility
Biochemistry Phase I R&D Scientific writingAccount ManagementAnalysisAllergy and immunologyAnalytical ChemistryAnalytical Method ValidationAnalytical methodsAnalytical proceduresAnalytical techniquesAssay developmentBioanalysisBioavailabilityBiopharmaceuticalsBudget ManagementBudgetingcGMPCharacterizationChromatographyChemistryClinical Data ManagementClinical DevelopmentClinical monitoringClinical operationsClinical pharmacologyClinical researchClinical Study DesignClinical study reportsClinical SuppliesClinical trial budgetingClinical trial designClinical trial managementClinical trialsCMCCMC CoachingCommunication SkillsCompliance with regulationsComplianceCurrent Good Manufacturing Practice (CGMP)Data ManagementData AnalysisData cleaningData entryDatabasesDatabase design and maintenanceDrug DeliveryDrug DevelopmentDrug development processDrug DiscoveryDrug metabolismDrug regulatory authoritiesDrug Safety and PharmacovigilanceDrug safety assessmentDrug substance developmentDrug substancesDrug Supply Management activitiesDue DiligenceeCTDEarly development stageEfficacy trialsEMAEnglishEntrepreneurshipEnzyme AssaysExperimentationFormulationFormulationsGalenicsgas chromatographyGastroenterologyGeneticsGMPGood Clinical Practice (GCP)Good Clinical Practice Veterinary (GCPv)Good Distribution Practice (GDP)Good Laboratory Practice (GLP)Good Laboratory Practice (GLP)Good Publication Practice (GPP)Good Manufacturing Practice (GMP)GXPHPLCHuman AnatomyICH guidelinesImmunoassaysImmunocytochemistry (ICC)ImmunofluorescenceImmunohistochemistryImmunohistochemistry (IHC)In VitroIn VivoIn vitro diagnostics (IVD)Investigative SafetyIt skillsKey Account ManagementLaboratoryLaboratory ResearchLaboratory SkillsLaboratory study designLaboratory TechniquesLaboratory testingLarge MoleculesLaboratory ManagementLeadershipLife SciencesLifesciencesLiquid Chromatography-UV (LC-UV)Liquid chromatographyLogisticsmanagementManagement ConsultingManufacturingManaging Clinical Trial SuppliesMarketing Authorisation Application (MAA)Medical DevicesMicrosoft ExcelMicroscopyMicrosoft PowerpointMicrosoft OfficeMicrosoft ProjectMicrosoft WordMolecular & Cellular Biologymolecular biologyMultiple dose tolerance studyNew Business DevelopmentNew Drug Application (NDA)Organic ChemistryOutlookOutsourcingpeople managementPharmaceutical DevelopmentPharmaceutical IndustryPharmaceutical ManufacturingPharmaceutical ResearchPharmaceutical salesPharmaceutical SciencesPharmaceuticalsPharmaceuticsPharmacistsPharmacodynamicsPharmacodynamicsPharmacogeneticsPharmacokineticsPharmacokineticspharmacologyPharmacovigilancePharmacyPhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)PowerPointPre-clinical researchPreclinical developmentPreclinical regulations and practicesPreclinical ResearchPreclinical SafetyPrenatal developmentPresentation SkillsPresentationsPreventative medicinePrinciples and ethics of clinical researchProduct designProduct developmentProduct launchProduct managementProject CoordinationProject PlanningProtein chemistryProject Portfolio ManagementProtocolPublic SpeakingPulmonary diseasesQA complianceQualificationQualitative ResearchQuality Assurance (QA)Quality AuditingQuality Control (QC)Quality ManagementQuality Management System (QMS)Quality SystemsQuality SystemsR&DR&DRandomization and blindingRandomization SystemsRate of drug eliminationreal-time PCRRecruitingRegistration of the productRegulatory affairsRegulatory ComplianceRegulatory submissionsRegulatory RequirementsRegulatory StrategiesReport WritingResearchResearch GovernanceRespiratoryRestructuringRisk AssessmentRisk ManagementSafety concerns (such as therapeutic ratio with respect to possible adverse effects)Safety reportingSafety trialsscienceScientific CommunicationsScientific methodologyScientific WritingSearch literature on clinical trialsSequence AnalysisSerious Adverse Event (SAE)Small moleculesSocial SkillsSpectroscopyStability testsStandard Operating Procedure (SOP)Statistical Data AnalysisStatisticsSterile drug productsSterilizationStrategic PlanningStudy approvalsStudy proposalsStudy protocolsSupervising CRAsTeachingTeam BuildingTeam LeadershipTeam ManagementTeamworkTechnical reportsTechnical SupportTechnology transferTime ManagementToxicologyTrainingTranslationTranslational MedicineTroubleshootingUnderstand how results translate to practiceUnderstand levels of research evidenceUnderstanding of regulatory guidelinesVaccinesValidationWriting Study Procedures and SOPs
Skills and Expertise
Analyze dataAnalyze dataAssist with experimentsbudgeting of R&D activitiesBuild CMC development planBuild trial master file (TMF)Chemistry Manufacturing and Controls (CMC) activitiesConduct literature searchesConduct post-marketing surveillance studyConduct research at universitiesConduct the trialConfirm protocol complianceCoordinate CMC-activitiescoordinating research projectsCreate SOPsCreate study documentsCreates a collaborative team environmentDesign data collection systemsDesign information leafletDesign post-marketing surveillance studyDevelop regulatory strategyEvaluate protocolsEvaluate stability data Write protocolsValidate data
Doctorate (PhD) in Pharmaceutical sciences, including clinical research from Ghent University in 2002
Clinical Pharmacist in Pharmacy from National University of Rwanda (NUR) in 1993
Training and Certification
Online Basics of European Regulatory Affairs, by TOPRA, UK in 2016 Certification
Online Certified Training: Clinical Research Associate (CRA) by Clinical Research Society, India in 2016 Certification
Nemerous international conferences on pharmaceutics and International regulatory requirements in Europe; USA and Africa (1998-2015) in 2015 Certification
Discovery management and creation of the company: CNED, Institut POITIERS (France). in 2008 Certification
Expert has 4 publications (Will be avalible with full profile)