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About Amgen Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology, and launched the biotechnology industry’s first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. About my job @ Amgen: Head of the Regulatory Affairs & Compliance department which is responsible for Clinical Trail submissions and amendments in Belgium & Luxembourg, post-marketing regulatory affairs, being local contact with health authority coordinating scientific technical advice meetings with global colleagues, healthcare compliance, quality assurance, data privacy, Qualified Person of Publicity & Information, Document retention. Being member of the country management team a strong cross functional collaboration on topics outside area of expertise are also an important aspect of my role.


Current Experience

  • Senior Manager Regulatory Affairs & Compliance
    Since May 2010
    As member of country management team responsible for healthcare compliance, regulatory affairs (clinical trials and postmarketing), Data Privacy Officer, Document Retention Officer, Quality Assurance (complaints handling) within the affiliate. Team management (incl Clin. Trial oversight South-Africa, Turkey and Israel)

Past Experience

  • Associate Director Regulatory Affairs & Pharmacovigilance Benelux
    November 2009 --- May 2010
    Responsible for regulatory affairs and pharmacovigilance departments in Belgian and Dutch affiliate (14 direct reports) and QP for quality assurance in Belgian affiliate. Besides the people management role, responsible for the maintenance of several national, MRP and CP registration files Ensure inspection readiness on pharmacovigilance and regulatory affairs

  • Head of Regulatory Affairs Benelux / Qualified Person
    February 2009 --- November 2009
    Managing a team of 14 people in regulatory, quality and pharmacovigilance in 2 locations (Berchem and Breda). Back-up QP for Benelux (meaning registered as QP for product release in Belgium and The Netherlands)

  • Regulatory Affairs Manager/Qualified Person
    December 2005 --- February 2009
    Maintenance of several national, MRP and CP registered products QA responsible Belgian affiliate Roll out of contract database in the affiliate Process excellence project on improving the complaints process

  • QA Supervisor
    December 2002 --- November 2005
    QA oversight from supplier quality (incoming inspection of deliveries by IPC team reporting to me), GDP in warehouse, GMP in dispensing, manufacturing & packaging, GLP in laboratory till customer complaints handling.

  • GDP Pharmacist
    April 2002 --- November 2002
    Qualification and validation of a new (ambient + cold chain) warehouse for Health Authority approval


Self Assessment :
Analytical thinkingInnovative thinkingInterest in knowledgeProactivityProblem solvingResiliencySelf-confidenceSelf-disciplineSelf-disclosureStrategic thinkingTrustIndependenceFlexibilityAdaptabilityApproachabilityAssertivenessAttention to detailAuthenticityCollaborationCompetitivenessCreative thinkingCritical thinkingDiligenceWillingness to compromise


Self Assessment :
Negotiation R&DBiopharmaceuticalsBiotechnologyCAPACross-functional team leadershipDrug regulatory authoritiesGMPGood Manufacturing Practice (GMP)Legal Considerations: Contracts and IndemnityMarketing approvalMicrosoft ExcelMicrosoft OfficeNegotiationPharmaceutical IndustryPharmacyPowerPointProblem-solving methods and troubleshootingProcess improvementProduct launchProject ManagementQuality Assurance (QA)Regulatory affairsRegulatory RequirementsSOPTeam LeadershipUnderstand how results translate to practiceUnderstanding of regulatory guidelinesWriting Study Procedures and SOPsData Privacyhealthcare complianceGood Distribution Practice (GDP)Business administration
LinkedIn Assessment :
Regulatory affairsCompliancequalityData PrivacyDocument ManagementPharmacovigilancePharmacistsPharmaceuticalsQualified Person GMP (recognition number 1871)Qualified Person Publicity&Information (recognition number 858)GMPQuality Assurance (QA)people managementRegulatory submissionsRegulatory RequirementscGMPQuality SystemsBiotechnologyGXPChange ControlValidationSOPLife SciencesCAPAQuality AuditingBiopharmaceuticalsProcess ValidationAuditingQuality ManagementRecords ManagementGroup PresentationsPublic SpeakingCollaborative Problem SolvingTeamworkPharmaceutical IndustryClinical researchQuality SystemsClinical DevelopmentGood Distribution Practice (GDP)LifesciencesSOPCompliance ProceduresDrug Development21 CFR Part 11GCPoncologymanagementVaccinesTechnology transferCRO

Skills and Expertise

Self Assessment :
Set-up quality policiesSolve problemsTrain off site staffTrain on site staffUse content management systemsWork under specific instructionsWritten presentation Create SOPs Guide students Interact with physicians Report data Use content management systemsAdjust methodsAdjust processes Adjust processes and methodsAnalyze dataAssist with proceduresCoachCoach staffCollaborate with medical teamCollaborate with project teamContract approvalCreate SOPsCreate standard operating procedure (SOP)Creates a collaborative team environmentData analysisDirect co-workersFollow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesGenerate regulatory submissions Guide staffHandle callsImplement Quality Management System (QMS)Interact with pharmacistsInteract with physiciansLabeling compliance with local regulationslifescienceMaintain Quality Management System (QMS)Manage contractors Manage Quality Management System (QMS) documentationmanaging a small teamManufacture of GMP batchesManufacture of non-GMP and GMP batchesOral presentationOrganise meetingsPrepare external auditsPrepare internal auditsPromotional materialsRegulatory documentationRegulatory submissionsReport non-compliance incidentsRespond to audit findings


  • in Pharmaco-economics and Disease management from IFB in 2008
  • Master in Management Course Pharmaceutical Business from IFB in 2008
  • Master in Business Administration from Europese Hogeschool Brussel in 2005
  • Master in Pharmaceutical Biotechnology from Ghent University in 2001
  • Master in Pharmacist from Universiteit Gent in 2000
  • High School in Maths - Sciences from Don Boscocollege in 1995

Training and Certification

  • Qualified Person Certification
  • Responsible Person for Publicity & Information Certification


BrightOwl Assessment:
Self Assessment:
Full Proficiency
Professional Proficiency
Elementary Proficiency

Work Preferences

  • Work From Home:
  • Work Regime:
    Permanent position :    Permanent placement% FTE
  • International:

Area / Region



Driving License
  • Yes