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Dr. Michael Klein

Inhaber, Geschäftsführer (CEO), mikle-pharm GmbH
Landau in der Pfalz, Germany

Skills

Regulatory Affairs
CMC
Qualified Person
Arzneimittelentwicklung
Qualitätssicherung

Timeline

Professional experience for Michael Klein

  • Current 15 years, since May 2010

    Geschäftsführer (CEO)

    mikle-pharm GmbH

    Support in Drug Development, Regulatory Affairs, Quality Assurance

  • 3 years and 3 months, May 2015 - Jul 2018

    Leiter Qualitätskontrolle und Leiter Zulassung

    pharmazeutischer Unternehmer (Schwerpunkt: non-EU)

  • 1 year and 8 months, Sep 2013 - Apr 2015

    Leiter Zulassung

    pharmazeutischer Unternehmer (Schwerpunkt: non-EU)

  • 1 year and 9 months, Apr 2012 - Dec 2013

    Berater (regulatory compliance, maintenance)

    Sandoz GmbH, Kundl (Österreich)

  • 2009 - 2010

    Freelance Regulatory Service Provider

    Self-employed/Freelancer

  • 2004 - 2008

    Senior CMC Expert, Authorised Officer

    Regulatory Service Provider

  • 1998 - 2003

    Head of Pharmaceutical Department

    Contract Laboratory

Educational background for Michael Klein

  • 1994 - 1998

    Pharmazeutische Technologie

    Universität Bonn

  • 1987 - 1992

    Pharmazie

    Universität Bonn

Languages

  • German

    First language

  • English

    Fluent

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