Markus Fries

Bis 2018, Regulatory Affairs, Baxter/Baxalta/Shire

Vienna, Österreich

Fähigkeiten und Kenntnisse

Life Cycle Management
Marketing Authorization Application
Development of Regulatory Strategies
Experience with Biologics and Pharmaceuticals
Expert in CMC
Centralised Procedure
Mutual Recognition Procedure
Decentralised Procedure
Line Extension
National Licenses
Clinical Trial Application
Development Strategies

Werdegang

Berufserfahrung von Markus Fries

  • Bis heute 6 Jahre und 6 Monate, seit 2018

    Regulatory Affairs

    Amomed Pharma GmbH

  • 2011 - 2018

    Regulatory Affairs

    Baxter/Baxalta/Shire

    In charge of directing and managing regulatory affairs activities for developing global strategies across product life cycles with a focus on CMC. Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies. Develop global CMC regulatory strategy for investigational and marketed products. Manage regulatory assessment and guidance on product compliance topics.

  • 2007 - 2011

    Scientist, Team Leader

    Baxter BioScience

    Development of new therapies for the treatment of haemophilia.

  • 2004 - 2007

    Post-Doc

    Queen Mary University of London

    Elucidating mechanism and specificity of the virulence factors pectin methylesterase and pectate lyase. Supervision of PhD, masters and bachelor students as well as a lab technican.

  • 2002 - 2004

    Post-Doc

    University of Cambridge

    Crystallographic studies of the thrombin-inhibitor heparin cofactor II

Ausbildung von Markus Fries

  • 1998 - 2001

    Biochemistry

    University of Cambridge

    Protein-protein interaction and catalysis in the pyruvate dehydrogenase multienzyme complex

  • 1992 - 1997

    Theoretical Medicine/Human Biology

    University of Marburg

    Diplom thesis: Expression, purification and crystallisation of the membrane protein dihydroorotate dehydrogenase Diplom subjects: Biochemistry, Molecular Biology, Immunology; Vordiplom subjects: Physics, Chemistry, Biology, Biochemistry, Physiology, Cell Biology, Anatomy and Histology

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