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Summary

european ra senior manager at baxter

Experiences

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. 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

Knowledge

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

Education

  • 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 0000

Area / Region

Waterloo, Belgique

Others

Driving License
  • Yes

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