Regulatory Affairs Assistant
Since October 2013
Regulatory Affairs : Check product labelling (NL/FR/DE) medical devices/cosmetics. Prepare the submission dossiers for advertising materials and follow up. Medical sampling : traceability medical sample distribution Train new comers in medical sampling. Prepare submission variation application for medicinal products (National Procedure) in Luxemburg. Prepare the submission dossiers for advertising materials and follow up. Translation/organise translation pack wording for medicinal products and medical training materials. Complete/update healthcare products database. Request and follow-up of CNK-codes at APB. Quality Management: Administrative control for medicinal products for the Benelux market. Random check medical devices. Support local Quality Management System Medical Affairs: Maintain Medical Questions database
February 2010 --- October 2013
Marketing Assistant BU Derma & Health care Regulatory Affairs Officer Pharmaceutical and Cosmetics department: coordinator notifications cosmetics and biocides to FAGG, contact person Ministry of Health, Headquarters and local Responsible pharmacist. Complaint handling coordinator (follow up and closing complaints) and contact person. Follow up and coordination of artworks on Regulatory level and with Headquarters. General marketing tasks: translations, presentations, support marketing events and meetings, support to BU manager, contact person contractor office.
August 2008 --- September 2009
Executive Secretary/Administrative Assistant: administrative support to General Manager and Country Marketing Manager, creation of coca cola Christmas card, organisation of events such as team building Belgian and Dutch affiliate, company lunches, meetings, etc.
April 2008 --- August 2008
Management Assistant – Therapy Advancement – administrative support to Director AT, Director Pricing and Reimbursement and physician (congresses, events)
Medical Information and Drug Information Administrative Assistant and Complaint Coordinator
July 2007 --- December 2007
- Support to Medical Affairs Manager and follow up of all medical and drug information related questions - Follow up complaints in collaboration with the Regulatory affairs Manager
Corporate and Regulatory Affairs Associate and Complaint Coordinator
September 2003 --- July 2007
- Packaging and labelling: development and update of printed packaging components in close collaboration with RA Manager and the manufacturing sites involved - Complaint Coordinator: follow up and elaboration of complaints in close collaboration with the Regulatory affairs Manager - Regulatory: complete and independent handling of requests for active substances and product quality complaints - Pricing and Reimbursement: support with registration and reimbursement dossiers
October 1997 --- October 2003
Cardiovascular department - Corporate Affairs department: administrative support, organisation of international sales meetings.
Master's degree in Language Interpretation and Translation from VLEKHO Business School Brussel in 1994