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Experiences

Current Experience

  • Regulatory Affairs Associate

    Brussels, Belgium
    Since April 2015

     

    • responsible Regulatory Affairs within zambon, tasks listed hereunder:

    • ensure registration of new products and maintenance of existing registrations through reviewing regulatory standards, implementing best practices in line with the current legislation, preparing regulatory documents, submission and follow-up of dossiers during the whole procedure.

    • act as the link between the company, its products and the regulatory body.

    • ensure Compliance with current legislation and guidelines (quality check of dossiers, leaflets, etc.)

    • updating of the global regulatory database for assigned products

    • handeling of qa, complaints, pharmacovigilances cases, submission of psurs...

     

     

    • Responsible Regulatory Affairs within Zambon, tasks listed hereunder:

    • Ensure registration of new products and maintenance of existing registrations through reviewing regulatory standards, implementing best practices in line with the current legislation, preparing regulatory documents, submission and follow-up of dossiers during the whole procedure.

    • Act as the link between the company, its products and the regulatory body.

    • Ensure compliance with current legislation and guidelines (quality check of dossiers, leaflets, etc.)

    • Updating of the global regulatory database for assigned products

    • Handeling of QA, Complaints, Pharmacovigilances cases, submission of Psurs...

     

Personality

Self Assessment :
CommunicativeCoordinationEfficiencyKindnessOptimismProactivityProblem solvingResult OrientedSociabilityTrustInterest in knowledgeAttention to detail

Knowledge

Self Assessment :
ApplicationsAdverse Events (AE)Drug regulatory authoritiesDrug Safety and PharmacovigilanceeCTDEnglishHealthcareICH guidelinesMicrosoft OfficeMultilingualNew Drug Application (NDA)Pharmaceutical IndustryRegulatory affairsRegistration of the productRegulatory ComplianceRegulatory RequirementsRegulatory submissions

Skills and Expertise

Self Assessment :
Administrative supportAdverse event reportingApprove patient informationAssemble regulatory applicationsFollow up projectsGenerate regulatory submissions General office managementManage regulatory activitiesPeople managementPrepare regulatory documentsPrepare responses to health authority queriesPromotional materialsRegulatory submissions

Languages

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

Area / Region

Waterloo, Belgium

Others

Driving License
  • Yes

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