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Past Experience

  • Regulatory Affairs Compliance Manager

    July 2011 --- November 2015


Self Assessment :
Understanding of regulatory guidelinesTrainingRegulatory submissionsRegulatory StrategiesRegulatory RequirementsRegulatory ComplianceRegulatory affairsRegistration of the productProject ManagementWriting Study Procedures and SOPsVaccinesTeamworkTechnical reportsTeam ManagementTechnical SupportSterile drug productsStem CellsStability testsSoftware DocumentationSerious Adverse Event (SAE)SDS-PAGESearch literature on clinical trialsScientific WritingSafety reportingRecruitingRandomization and blindingQuality Management System (QMS)QA complianceProduct developmentProduct launchPrinciples and ethics of clinical researchProblem SolvingPresentation SkillsPreclinical regulations and practicesPowerPointPhases of clinical development (phase I to IV)PharmacovigilancePharmacokineticsPharmacodynamicsPharmacodynamicsPharmaceutical SciencesPharmaceutical ResearchPatient recruitmentOutlookOncology Clinical ResearchMicrosoft WordMolecular & Cellular BiologyMicrosoft PowerpointMicrosoft ProjectMicrosoft ExcelMicrobiologyMarketing Authorisation Application (MAA)Marketing approval Biochemistry Medical devices Negotiation Scientific writingAnalytical Method ValidationBiomarkersBiopharmaceuticalsBiotechnologyCell CulturecGMPChange ControlChemistry, Manufacturing, and Controls (CMC)Clinical DevelopmentClinical researchCMC Regulatory AffairsCompliance with regulationsCross-functional team leadershipCurrent Good Manufacturing Practice (CGMP)Drug regulatory authoritieseCTDEMAGood Clinical Practice (GCP)Good Manufacturing Practice (GMP)GXPGynecologic oncologyIMPDInformed Consent DocumentsKnowledge of the drug development processMedical Devices

Skills and Expertise

Self Assessment :
Assemble regulatory applicationsDevelop regulatory strategyGenerate regulatory submissions Interact with regulatory stakeholdersLabeling compliance with local regulationsLate-stage regulatory filing (MAA, BLA)Manage regulatory activitiesPrepare regulatory documentsRegulatory documentationRegulatory submissionsSubmit regulatory applicationsWriting regulatory documentsWritten presentationWrite papersWork cross-functionallyWork collaboratively with the other members of the clinical research team Translate strategy into operational plansTrain StaffSearch literature on clinical trialsReview study protocolsReview manufacturing documentationReview clinical study reportsReport serious adverse events (SAE)Provide support for scientific and/or technical projectsProvide input to process improvement initiativesPromotional materialsPrepare responses to health authority queriesPlan work to meet objectives and deadlinesOrganise meetingsOral presentationNegotiationMarket approvalManage multiple projectsLiaise with research team in order to accurately collect and record dataLiaise with professionals in other divisions of the company as requiredLead teamsInterpret scientific dataInterpret analytical resultsInteract with ethics committeeReview protocolsProvide trainingproject managementLiaise with research teamEthics committee submissionsEstablish professional relationships with partnersEnsure good clinical practice (GCP)Develop training materialsDevelop strong internal relationships with stakeholders Develop protocols Create SOPs Control data Analyze data Analytical skills


  • Master in Bioengineering from UCL in 1988

Training and Certification

  • Authorisation of Biophamaceutical, Biosimilars and Advanced Therapies in Europe in 2013 Training
  • Cell Culture in 2011 Training
  • Medical Devices CE Conformity in 2009 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    Full Proficiency
    Professional Proficiency

Work Preferences

  • Positions I am interested in:
    Director Regulatory Affairs Regulatory Affairs Consultant Regulatory Project Manager Regulatory Affairs Manager Clinical Development Consultant CMC Project Manager Compliance Manager
  • Positions I am NOT interested in:
    Administrative Assistant Assistant Bioinformatician BioStatistician Biostatistics Masters graduate Clinical Research Associate (CRA) Clinical Study Nurse (SN) Clinical Trial Assistant (CTA) Customer Service Manager Customer Service Assistant Customer Service Representative Customer Services Manager Doctoral Researcher Graduate Graphic Designer jobstudent Junior Laboratory Technician Lab Analyst Lab Technician (Toxicology) Laboratory Assistant Master student Master Thesis Mechanical Technician Medical translator Nurse Office Manager Operator Ph.D. Student PhD Candidate PhD student Postdoctoral fellow Postdoctoral Research Fellow Research fellow Research internship Research Technician Research Trainee Sales Administrator Sales Manager Sales representative Student Student Job Student Researcher Student Worker Technician Veterinarian Veterinary Clinical Manager Veterinary Clinical Research Sr. Associate Waitress Ziekenhuisapotheker
  • Locations I am interested in:
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position
  • International:

Area / Region

Wavre, Belgium


Driving License
  • Yes

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