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
International Regulatory Affairs ManagerJanuary 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 AssociatesJanuary 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 AssociateJanuary 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.
LinkedIn Assessment :
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
Area / Region