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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

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 0

Training and Certification

  • Farmaceutische Wetenschappen Certification

Languages

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

Area / Region

Brussels

Others

Driving License
  • No