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Regulatory Competence for Russian Federation and CIS

Dr. Edelgard Rehak Consulting

Dr. Edelgard Rehak

Dr. Edelgard Rehak Consulting

  • Since 2015

    Edelgard Rehak Consulting/
    Co-owner of RM Beteiligung GmbH

  • 2015 – 2011

    Head Regulatory Sanofi / Medical Director of Zentiva;
    Russian Federation

    - Managing of Sanofi and Zentiva portfolio in Russian Federation
    - Implementing a local in-house CRO for bioequivalence studies
    - Responsible for outsourcing activities of toxicological studies
    - QA for generics
    - Audits of Russian local manufacturing sites
    - Located in Moscow, Russian Federation

  • 2010 – 2011

    Dr. Edelgard Rehak Consulting; Germany

    - Registration of first biosimilars in Russia and Ukraine
    - Managing Gx portfolio for a leading Pharmaceutical Company in Germany

  • 2007 – 2011

    Head Regulatory NOVARTIS; Ukraine

    - Managing of NOVARTIS portfolio in Ukraine and CIS
    - QA of a local re-packaging unit in Ukraine
    - Located in Kiev, Ukraine

  • before 2007

    Various function within HEXAL AG; Germany