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Experiences

Current Experience

  • Regulatory Affairs Manager & Compliance Officer Benelux


    Since January 2012

Past Experience

  • Regulatory Affairs Manager

    July 2011 --- January 2012
    • maintain and update existing regulatory authorizations (mrp/dcp) in belgium, luxembourg and the netherlands. • compile and submit regulatory variations and renewal Applications and obtain approval for nationally approved products. • responsible for interactions with regulatory authorities in belgium, luxembourg and the netherlands. • generate regulatory translations, prepare, review, and approve labeling and perform proof-reading of artwork for belgium and the netherlands.

  • Industrial Pharmacist

    January 2008 --- June 2011
    responsible for implementation of the Quality System and coordination of all qa activities (complaint handling, batch release, technical agreements, audits, Change Control, capa's,...). acting as the Qualified Person. coordination of the Regulatory Affairs team (ra officers) to ensure timely approval and registration of Pharmaceutical products. provides support for writing analytical variation dossiers with focus on cmc. experience with national, mrp and dcp registrations. keeping abreast of international legislation, guidelines and customer practices. advising team members and manufacturers on regulatory requirements and Strategy. as representative of the new products launch team responsible for advising and coordinating of product flow and Documentation and specifying storage, labelling and Packaging requirements. develop, manage and maintain good working relationships with competent authorities.

  • Site Compliance Administrator

    September 2001 --- December 2007
    responsible for writing the module 3 (cmc) for the products manufactured at the site (sterile and Biological products). compiling variation dossiers for worldwide submission. ra representative in several project teams, setting up the Strategy for the submissions worldwide. coördinating the implementation of changes at the production site. responsible for the technical file for Medical Devices, involved in the Quality Management System and ISO audit for Medical Devices.

Knowledge

LinkedIn Assessment :
eCTDPharmaceutical IndustryRegulatory affairsQuality SystemsChange ControlCAPARegulatory RequirementsManufacturingGMPSOPMedical DevicesValidationRegulatory submissionsQuality Assurance (QA)FDACMCPharmaceuticsPharmacovigilance

Education

  • in Industrial Pharmacist from Katholieke Universiteit Leuven in 2001
  • in Latin - Mathematics from STK in 1995

Area / Region

Elewijt, Zemst, België

Others

Driving License
  • No

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