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Experiences

Current Experience

  • Senior Global Regulatory Affairs Manager / Biosimilars
    Since February 2011
    Responsible for global regulatory strategy and submissions for selected biosimilar monoclonal antibodies

Past Experience

  • Regulatory Affairs Manager
    February 2008 --- January 2011
    Regulatory oversight for complex biobetter growth factor. Support licensing and post approval activities for biosimilar protein

  • Regulatory Affairs Associate
    November 2004 --- January 2008
    Regulatory Maintenance: intravenous immunoglobulins

  • Regulatory Affairs Consultant
    April 2004 --- October 2004

Knowledge

LinkedIn Assessment :
Protein chemistryRegulatory affairsPharmaceutical IndustryLife SciencesBiotechnologyClinical DevelopmentClinical trialsRegulatory submissionsGMPTechnology transferBiopharmaceuticalsCROFDASOPDrug DevelopmentGCPValidationoncologyPharmaceuticsRegulatory RequirementsGLPPharmacovigilanceMedical DevicesVaccines

Education

  • Master's Degree in Drug Regulatory Affaris from Rheinische Friedrich-Wilhelms-Universität Bonn in 2006
  • Postdoctoral reasearcher in Trafficking of HCMV glycoproetins in polarized epithelial cells from University of California, San Francisco in 2001
  • Doctor of Philosophy (Ph.D.) in Cellular and Molecular Biology from University of Goettingen in 1995

Area / Region

London, United Kingdom

Others

Driving License
  • No