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Summary

v

Experiences

Current Experience

  • Regulatory Affairs Associate


    Since January 2015
    responsible for latin america, asia pacific, mea and other european non-eu countries - obtaining and maintaining world-wide product licenses of the existing product portfolio -> * good knowledge of current applicable legislations/ directives * compile registration/ renewal files timely to obtain/ maintain Marketing authorisation world wide * review and assess change requests for registered products and define impact on registration files - post Marketing vigilance - provide support on ra related topics during the development of new Diagnostic products and on obtaining market approval - maintaining the regulatory intelligence and regulatory status of products up-to date in the implemented Databases Internal Auditor Responsible for Latin America, Asia Pacific, MEA and other European non-EU countries - Obtaining and maintaining world-wide product licenses of the existing product portfolio -> * Good knowledge of current applicable legislations/ directives * Compile registration/ renewal files timely to obtain/ maintain marketing authorisation world wide * Review and assess change requests for registered products and define impact on registration files - Post marketing vigilance - Provide support on RA related topics during the development of new diagnostic products and on obtaining market approval - Maintaining the regulatory intelligence and regulatory status of products up-to date in the implemented databases Internal auditor

Past Experience

  • Site Compliance Support Technician

    January 2014 --- January 2015
    responsible for following tasks - coordinating ancillary document requests in the context of renewals, new registrations.. - responsible contact for all renewals - support in tender document requests - support in preparing variations (pcrs, gather all requested data, manual preparation of coas of api/ raw materials) - responsible for Regulatory Compliance checks of api, raw materials and drug product (following pharmacopeial updates,..) - issuing lotplan implementations according the applicable specifications - support stability team: issuing and verifying regulatory stability reports

  • Project Assistant setup

    November 2011 --- January 2014
    - preparation of the Laboratory specifications in close collaboration with the Project Manager, describing the services foreseen in a specific project. - technical preparation of project database - preparation of the internal start-up document to provide all departments with trial specific directives as estalished in agreement with the sponsor - preparation of the study specific documents - Communication with sponsor CRO/CRA to guide start-up of Clinical trials - coordination of the Translation of the instruction leaflets - Documentation of the complete setup in a master file - following standard operating procedures and within guidelines of qa

Personality

Self Assessment :
Attention to detailFlexibilityProactivityAnalytical thinkingResponsibilityCollaborationCommunicativeEfficiencyOptimismOrganizationProblem solvingResult Oriented

Knowledge

Self Assessment :
Biochemistry21 CFR Part 11Adverse Events (AE)Analytical methodsAntibodiesAuditingBiologyBiomedical SciencesBiotechnologyBudgetingBusiness PlanningCAPACE CertificationcGMPChange ControlChange ManagementChemistryChemistry, Manufacturing, and Controls (CMC)Clinical Trial Management System (CTMS)CMC Regulatory AffairsCompliance with regulationsDesign VerificationDNADrug development processDrug regulatory authoritiesEnglishEnzyme-linked immunosorbent assay (ELISA)Failure Mode and Effect Analysis (FMEA)FDAGood Clinical Practice (GCP)ICH guidelinesIn vitro diagnostics (IVD)INDISO 13485ISO 14971ISO 14001Knowledge of the drug development processLIMSMarketing Authorisation Application (MAA)Medical DevicesMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordMitigationMolecular & Cellular BiologyMarket accessMarketing approvalNew Drug Application (NDA)PCRPharmacodynamicsPharmacokineticsPhases of clinical development (phase I to IV)PresentationsProblem-solving methods and troubleshootingProduct developmentQA complianceQuality AuditingQuality Management System (QMS)recombinant DNA technologyRegistration of the productRegulatory affairsRegulatory ComplianceRegulatory RequirementsRegulatory StrategiesRegulatory submissionsRoot Cause Analysis (RCA)Search literature on clinical trialsSerious Adverse Event (SAE)Six SigmaStability testsStandard Operating Procedure (SOP)Start-upsTranslationUnderstanding of regulatory guidelinesWriting Study Procedures and SOPs
LinkedIn Assessment :
Clinical trialsICH-GCPQuality AssuranceLifesciencesPharmaceutical IndustryClinical researchCTMSCROGCPGMPRegulatory affairsMedical DevicesIVDDANVISAISO 13485SOPBiotechnologyClinical DevelopmentRegulatory submissionsLife SciencesHealthcareoncology

Skills and Expertise

Self Assessment :
Regulatory documentationRegulatory submissionsSubmit regulatory applicationsManage regulatory activitiesWriting regulatory documentsReview clinical study reportsReview protocols Create SOPsSet up a clinical studyCommunicate with sponsor Analytical skills Control data Interact with physiciansPrepare internal auditsFollow-up of internal auditsFollow-up of external auditsCommunicate with investigatorManage Quality Management System (QMS) documentationAdverse event reportingAlzheimerArchive study documentsArchive trial documentation and correspondence.Assemble regulatory applicationsAttend investigator meetingAttend seminars, courses and meetings within and outside the companyCollaborate with project teamCommunicate effectively on different company levelscontrol different protocol versions and other essential documentsCreate study documents

Education

  • Bachelor's degree (obtained all credits) in Farmaceutical and Biological labtechniques from Katholieke Hogeschool Kempen in 2008
  • candidate in science in Biomedical Sciences, General from Universiteit Antwerpen in 2004
  • in Wetenschappen - Wiskunde from Koninklijk atheneum Turnhout in 2000

Training and Certification

  • IVD regulation in 2016 Training
  • ISO 19011:2011 in 0000 Certification

Languages

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

Work Preferences

  • Notice Period:
    6 weeks
  • Positions I am interested in:
    Regulatory Affairs Associate Regulatory and Start-Up Specialist Regulatory Affairs Consultant Drug Safety Officer Clinical Research Associate (CRA) Regulatory Project Manager
  • Locations I am interested in:
  • Work From Home:
    Yes, 0 to 1 days per week
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl employee :    100% FTE
  • International:
    Yes

Area / Region

Gent, België

Others

Driving License
  • Yes

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