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Experiences

Current Experience

  • Freelance Regulatory Affairs & Quality Assurance


    Since May 2013
    - major ra experience: Regulatory Affairs (national & international): preparation & follow-up of submission of variations and new registrations of ma for medical drugs in benelux and rest of world countries. other ra experience: foodsupplements, Clinical trials (preparation & submission of cta and follow up of Clinical trials). - qa complaint handling, pqr review, administrative batch release - medical Training. available for new projects for 3 days/week - Major RA experience: Regulatory Affairs (national & international): preparation & follow-up of submission of variations and new registrations of MA for medical drugs in Benelux and Rest of World countries. Other RA experience: Foodsupplements, Clinical trials (preparation & submission of CTA and follow up of clinical trials). - QA complaint handling, PQR review, administrative batch release - Medical training. Available for new projects for 3 days/week

Past Experience

  • Docent

    September 2013 --- August 2015
    Teaching Communication and Galenics for the Education of "technical Pharmaceutical assistant" (adult Education)

  • Regulatory Affairs Manager

    August 2010 --- September 2011
    responsible for registration, Pharmacovigilance, publicity and qa of prescription drugs, otc and Food supplements for national market (be & lux).

  • Clinical Trial Regulatory Affairs Manager

    January 2008 --- August 2010
    overall coordination of all european Regulatory Affairs activities related to Clinical Development of a medicinal product. responsible for a team of 16 people.

  • International Regulatory Affairs Manager

    January 2004 --- January 2008
    manager of team (4 people) responsible for the creation and follow-up of registration files for europe, ceec, russia & cis countries, asia, australia, new zealand, central & south america, middle east, africa & magreb, in accordance with local requirements. maintaining of contacts with local subsidiaries and Global Marketing department.

  • International Customised Files Associates

    January 1999 --- January 2004
    responsible for the creation and follow-up of registration files for asia, australia, new zealand, central & south america, middle east and africa & maghreb, in accordance to the local requirements. maintaining of contacts with the local subsidiaries and Global Marketing departments.

  • Animal Health Drug Regulatory Affairs Associate

    January 1996 --- January 1999
    responsible for the registration of Veterinary drugs in belgium and luxembourg: submission and follow-up of registration files at the ministry of Health, review of Packaging material, maintaining of contacts with the authorities, the Veterinary Marketing department and the German mothercompany.

  • Clinical Research Associate (CRA)

    January 1995 --- January 1996
    in-house follow-up and co-monitoring of Clinical trials (Phase 2 and 3): administrative follow-up of the studies, review of the case report forms, maintaining of contacts with doctors and Hospitals.

Knowledge

LinkedIn Assessment :
osteopathysportsmassageEquine TherapyEquine MassageCanine MassageRegulatory affairsosteopathyClinical DevelopmentPharmacovigilancePharmaceutical IndustryClinical researchClinical trialsMedicineMedical affairsPharmaceuticsVeterinary

Education

  • Industrial Pharmacist in Farmaceutische wetenschappen from Universiteit Antwerpen in 1994
  • Pharmacist in from Universiteit Antwerpen in 1991
  • in from Sint-Pieterscollege te Jette in 0000

Training and Certification

  • Farmaceutische Wetenschappen in 0000 Certification

Languages

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

Area / Region

Brussels

Others

Driving License
  • No

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