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European RA Senior Manager at Baxter


Current Experience

  • Senior Regulatory Affairs Manager
    Since August 2008
    Management of a team of 4 persons to maintain and extend a portfolio of injectable drugs covering hundreds of different licences in all EMEA region. Complete CMC writing for all CTD Module 3 with specialisation in Plastic containers-closures, Analytical methods and Stability studies. New European submissions of Medicinal Products RA dossier (MRP, DCP, national) in all EMEA region. Filing of variations in EMEA region. Communication with competent authorities to respond to questions.

Past Experience

  • Regulatory Affairs Manager
    May 2003 --- August 2008

  • Regulatory Affairs Associate
    November 1995 --- April 2003


LinkedIn Assessment :
3 years of experience in Medical Devices Regulatory Affairs12 years of experience in Medicinal Products Regulatory AffairsPeople management experienceEmployee ManagementCMCRegulatory RequirementsRegulatory affairs


  • Master in Sciences in Chemical Engineering from Université catholique de Louvain in 1995
  • Industrial Engineer in Polymers from Institut Meurice in 1991
  • in from Decroly in 0

Area / Region

Waterloo, Belgique


Driving License
  • Yes