
Dr. Barbara Malitschek
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Barbara Malitschek
- 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
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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