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Summary

Regulatory Affairs manager export (medicins including cmc part, Medical Devices, cosmetics, biocidal products and Food supplements)

Experiences

Current Experience

  • Regulatory Affairs Manager Export


    Since November 2013

Past Experience

  • Regulatory Affairs Officer

    August 2009 --- October 2013

Knowledge

Self Assessment :
Medical devices R&D Scientific writingBiomarkersCMC Data AnalysisCommunication SkillsData ManagementDrug regulatory authoritiesEMAEnglishGMPMarketing Authorisation Application (MAA)Medical writingpeople managementPharmaceutical IndustryPre-clinical researchProject ManagementProblem-solving methods and troubleshootingRegulatory affairsRegistration of the productRegulatory StrategiesTime ManagementValidation

Skills and Expertise

Self Assessment :
Analyze data Build the CMC development plan Develop protocols Interpret data Report data Write papers Guide studentsBiomarker ResearchChemistry Manufacturing and Controls (CMC) activitiesCoachCollaborate with project teamConduct literature searchesConduct research at universitiesCoordinate CMC-activitiescoordinating research projectsDevelop regulatory strategyEvaluate stability data and impurity identification/synthesisEvaluate physico-chemical dataExecute scientific projectsGenerate regulatory submissions Guide staffLate-stage regulatory filing (MAA, BLA)Labeling compliance with local regulationsmanaging a small teamManuscript preparation and reviewOrganise meetingsPrepare CMC source documents Prepare regulatory documentsPresent data at congressRegulatory submissionsWriting regulatory documents

Education

  • PhD Biomedical Sciences in from KU Leuven in 2008
  • Master degree Biomedical Sciences in from KU Leuven in 2004

Languages

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

Work Preferences

  • Positions I am interested in:
    Medical Writer Postdoctoral Researcher Project Manager Regulatory Affairs Manager researcher
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    No

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Zele, België

Others

Driving License
  • No

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