Dr. Barbara Malitschek

Studentin, Molecular Biology, Ludwig-Maximilian University Munich and Julius-Maximilian University Würzburg
Munich, Germany

Fähigkeiten und Kenntnisse

12 Years experience in Regulatory Affairs in Pharm
PMDA (Japan)
KFDA (Korea) and TÜV (EU) for consultation process

Werdegang

Berufserfahrung von Barbara Malitschek

  • Current 6 years and 8 months, since Oct 2019

    Senior Consultant

    Regular Services
  • 1 year, Oct 2018 - Sep 2019

    Corporate Director Reguatory Affairs

    STS Medical Group

  • 3 years and 11 months, Nov 2014 - Sep 2018

    Global Head Regulatory Affairs

    Nobel Biocare

  • 2 years and 2 months, Jul 2012 - Aug 2014

    Manager Regulatory Affairs

    OptumInside

  • 8 years and 5 months, Jan 2003 - May 2011

    Director Regulatory Affairs

    Institut Straumann AG

    Various Positions held: Head International Registration, Head Regenerative Product Registrations. Leading the regulatory affairs group at Institut Straumann responsible for international product registrations (non active medical devices). Timely submission of product registrations and monitoring of all submission activities internationally. Product maintenance activities. Representing RA in management team, development teams and portfolio planning activities.

  • 1 year and 7 months, Apr 2001 - Oct 2002

    Manager Regulatory Affairs

    Pohl-Boskamp

    Renewal and variation of European and international Product Registrations. Development of submission dossiers for MRP in CTD in Europe. Responsible for Asia-Pacific registrations. Compilation of chemical pharmaceutical expert reports. Updating of older dossiers for compliance with NTA. Due diligence for in sourcing of product dossiers. RA representative in development teams. Acting as Information officer.

  • 2 years and 3 months, Jan 1999 - Mar 2001

    Manager Regulatory Affairs

    TAD Pharma

    Lifecycle management of Product Registrations. Development of submission dossiers for MRP in CTD in Europe. Compilation of chemical pharmaceutical expert reports. Leading University cooperation for the development of a recombinant vaccine. RA representative in management team for new technologies.

  • 3 years and 7 months, Jun 1995 - Dec 1998

    Research Scientist

    Novartis AG

    Nervous-System Research. Scientific work for the structural and functional characterization of metabotrophe Glutamate receptors. Establishment of eukaryotic expression systems for recombinant proteins.

Ausbildung von Barbara Malitschek

  • Bis heute

    Molecular Biology

    Ludwig-Maximilian University Munich and Julius-Maximilian University Würzburg

    Receptor Tyrosinkinases. Recombinant expression systems. Structural and functional characterisation.

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • French

    A1-A2 (Grundkenntnisse)

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