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Experiences

Current Experience

  • Regulatory Affairs Team Leader
    Since January 2015

Past Experience

  • Regulatory Affairs Manager
    October 2007 --- December 2014
    Regulatory Affairs Project Management for new products, life cycle management marketed products, coordinating development projects, giving regulatory input in analytical development projects, manufacturing process changes and process validation, people management responsibilities, writing CMC dossiers, defining regulatory strategy.

  • Regulatory Affairs Manager & GDP responsible pharmacist
    May 2003 --- October 2007

  • Regulatory Affairs Officer
    March 2000 --- May 2003

  • Process validation Assistant
    September 1999 --- March 2000

Knowledge

LinkedIn Assessment :
Regulatory affairsRegulatory StrategyPharmaceutical IndustryRegulatory submissionsGMPValidationBiotechnologyQuality SystemsChange ControlCMCAnalytical Chemistry

Education

  • Industrial pharmacist in from Katholieke Universiteit Leuven in 1999
  • Pharmacist in from Katholieke Universiteit Leuven in 1998

Area / Region

De Pinte, Belgium

Others

Driving License
  • Yes