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Experiences

Past Experience

  • Lead Regulatory Affairs Manager Consumer Health Diegem, Machelen, Belgium

    April 2015 --- October 2016
    • functional responsible over the ra consumer Health team
    • ensure timely and compliant completion of operational Regulatory Affairs activities in the broad range of products (medicines, Food supplements, Medical Devices and cosmetics in be /lu)
    • provide regulatory scientific and strategic guidance to business and supporting functions (local/global)
    • actively contribute to the development and implementation of business opportunities (new Product Development, in-Licensing projects,…)
    • represent bayer in industry associations (bachi, unamec, naredi) and towards Health authorities (fagg, dg4, favv, moh gdl) +
    • 2015: Founder and President of unamec self-care MD section
    • represent Regulatory Affairs in cross-functional team meetings (local/global)
    • input in and review of promotional activities / material
    • 2016 winner of the global Innovation award

  • Regulatory Affairs Manager Diegem, Machelen, Belgium

    April 2012 --- March 2015
    • registration /notification of medicines, Food supplements, Medical Devices and cosmetics in be/lu
    • support the “product life cycle management
    • participation in workgroups from industry associations (bachi, unamec, naredi)
    • support business with advise on new products, claims and labelling
    • review of promotional activities / material

  • Drug Regulatory Affairs Associate Brussels, Belgium

    July 2007 --- March 2012

  • Pharmacist Haacht

    September 2005 --- June 2007

Personality

Self Assessment :
Analytical thinkingAdaptabilityApproachabilityAttention to detailCollaborationCommunicativeCoordinationCreative thinkingCuriosityEfficiencyFlexibilityIndependenceInterest in knowledgeProactivityProblem solvingResponsibilityTrust

Knowledge

Self Assessment :
Adverse Events (AE)Registration of the productRegulatory affairsRegulatory ComplianceRegulatory RequirementsRegulatory StrategiesRegulatory submissionsRisk ManagementDrug regulatory authoritiesDrug Safety and PharmacovigilanceeCTDGood Clinical Practice (GCP)Good Distribution Practice (GDP)Healthcare industry

Skills and Expertise

Self Assessment :
Analytical skillsApprove suitability of patient information and consent documentsAssemble regulatory applicationsContribute medical, clinical expertise and scientific advice to all allied departments in local affiliate in particular support to the local clinical development team for timely execution of studies conducted in the affiliate and to DRA in interactions with authorities.Create SOPsInteract with pharmacistsInteract with physiciansLabeling compliance with local regulationsLiaise with professionals in other divisions of the company as requiredmanaging a small teamMarket approvalRegulatory submissionsWrite statistical reports

Education

  • Master in Pharmacy from Katholieke Universiteit Leuven in 2005

Training and Certification

  • BRAS Advanced course in module 5 in 2015 Training
  • Intensive Course in Dermato-Cosmetic Sciences in 2014 Certification
  • BRAS Advanced course in module 3 in 2009 Certification

Languages

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

Work Preferences

  • Positions I am interested in:
    Regulatory Affairs Manager Medical Advisor Market Access Manager
  • Positions I am NOT interested in:
    Clinical Research Associate (CRA)
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    80% FTE
  • International:
    No

Area / Region

Boortmeerbeek, Belgium

Others

Driving License
  • Yes

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