Senior Regulatory Affairs Consultant (Benelux)September 2014 --- February 2015
product portfolio: hiv, hepatitis, oncology/ ifi and Cardiology submission of Clinical Trial Applications & amendments to the ca submission of variation dossiers (nat) to the ca reporting of Adverse Events & Drug Safety information artwork review review of promotional materials revision of educational brochures (rma) revision of sops
Regulatory Affairs ConsultantJune 2014 --- July 2014
compiling and reviewing countries' product information files in comparison with previous submitted variations and dossiers, module 3 and cmc Documentation
Europe Regulatory Integration Liaison SupportSeptember 2013 --- March 2014
supporting the Planning, execution and tracking of merger initiative tasks : working with cross-divisional groups (e.g. Regulatory Affairs, regulatory Operations, product source management, cmc, rio team members) to identify and fulfill requirements associated with individual regulatory filings. working closely with ril to ensure regulatory data are available for use in integration office processes, such as regional reporting. working closely with cross-functional teams to provide country-level status and reporting. securing continuous follow-up & interaction with countries’ ra and rae on execution status and on tracking milestones’ achievements of the individual merger project plans.
Regulatory Affairs ConsultantApril 2013 --- May 2013
temporary ra support : preparation and submission of variation application dossiers (np, mrp, dcp) in belgium and the netherlands. update of smpc, leaflet and Packaging materials
Regulatory Affairs ConsultantAugust 2012 --- February 2013
temporary replacement of the ra manager for otc : preparation and submission of variation Applications dossiers (np, mrp, dcp) in belgium notification of changes to dossiers for cosmetics, Food supplements and Medical Devices, and if applicable, artwork modifications.
Regulatory Affairs OfficerJanuary 2006 --- January 2008
preparation and submission of variation application dossiers (np, mrp) in belgium and the netherlands. update of smpc, leaflet and Packaging materials. assistance in the follow-up of ongoing Clinical trials, sae's reporting. assistance in literature references as a source for medical information and promotional materials.
Assistant in Clinical and Regulatory DevelopmentJanuary 2002 --- January 2004
preparation and submission of study related Documentation for the investigating centers and for the approval of the competent authorities : area : Interventional Cardiology (ptca) coordination of a post-Marketing study in europe and asia, assistance in a new Clinical Trial for a new Medical Device (des) in order to get ce marking in europe, in collaboration with an independent CRO.
LinkedIn Assessment :
Bachelor Chemistry in from Katholieke Universiteit Leuven in 1998
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