Daniela Maurer

Bis 2011, Assistant Regulatory Affairs Germany, Teva ratiopharm
Ulm, Germany

Fähigkeiten und Kenntnisse

Dokumentenmanagement-System
Datenbank
MRP
nationale Verfahren
DCP
Variations
eCTD
NeeS
eCTD Publishing
eSubmission
Projektkoordination
mehrjährige Erfahrung im Bereich Regulatory Affair
Projektmanagement
Generika
Kenntnisse in MS-Office
Deutsch
Organisationstalent
Verantwortungsbewusstsein
Genauigkeit
Freundlichkeit
Schnelle Auffassungsgabe
Logisches Denken
Optimismus
Pharmazie
Technisches Verständnis
Pharmaindustrie
Arzneimittelzulassung
Engagement
Teamfähigkeit
Selbstständigkeit
Englischkenntnisse

Werdegang

Berufserfahrung von Daniela Maurer

  • Current 3 years and 3 months, since Apr 2023

    Senior Specialist Regulatory Affairs Germany & Austria

    Teva ratiopharm, Ulm

    - Coordination, preparation and submission of variations and new submissions for national German and Austria procedures and EU procedures (administrative and quality part) in accordance of pharmaceutical legislation. - Maintenance of regulatory data bases and document management systems including key user activities, preperation of Working Instructions as well as corresponding training. - eCTD - eCTD publishing, electronic submission

  • Current 13 years and 5 months, since Feb 2013

    Specialist Regulatory Affairs Germany & Austria

    Teva ratiopharm

    - Coordination, preparation and submission of variations for national german procedures and EU procedures (administrative and quality part) in accordance of pharmaceutical legislation. - Maintenance of regulatory data bases and document management systems including key user activities, preperation of Working Instructions as well as corresponding training. - eCTD, NeeS - eCTD publishing, electronic submission

  • 1 year and 3 months, Dec 2011 - Feb 2013

    --

    Mutterschutz + Elternzeit

  • 11 months, Feb 2011 - Dec 2011

    Assistant Regulatory Affairs Germany

    Teva ratiopharm

    - Coordination, preparation and submission of variations for national german procedures and EU procedures (administrative and quality part) in accordance of pharmaceutical legislation. - Support in the merging of different databases - Maintenance of regulatory data bases and document management systems including key user activity - electronic submission

  • 2 years and 8 months, Jun 2008 - Jan 2011

    Assistant Regulatory Affairs responsible for Scandinavia

    Teva ratiopharm

    - Maintenance of regulatory data bases and document management systems including key user activity - Coordination and preparation of variations for national and international local procedures and EU procedures (quality part) in accordance of pharmaceutical legislation.

  • 1 year and 2 months, May 2007 - Jun 2008

    --

    Mutterschutz + Elternzeit

  • 3 years and 5 months, Jan 2004 - May 2007

    Assistant Regulatory Affairs

    Teva ratiopharm

    - Maintenance of regulatory data bases and document management systems including key user activity - Coordination and preparation of variations for national and international local procedures and EU procedures (quality part) in accordance of pharmaceutical legislation.

  • 2 years and 8 months, May 2001 - Dec 2003

    Pharmazeutisch-technische Assistentin (PTA)

    Öffentliche Apotheken

  • 5 months, May 1998 - Sep 1998

    Pharmazeutisch-kaufmännische Angestellte

    Öffentliche Apotheken

Ausbildung von Daniela Maurer

  • 2 years and 7 months, Sep 1998 - Mar 2001

    Pharmazeutisch Technische Assistentin

    Kreisberufsschulzentrum Ellwangen

  • 2 years and 9 months, Sep 1995 - May 1998

    Pharmazeutisch Kaufmännische Angestellte

    Kaufmännische Berufsschule Augsburg

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    B1-B2 (Gute Kenntnisse)

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