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
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.
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