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Beate Sonntag

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Managing partner, Geschäftsführer / Regulatory Affairs Consultant, SORAPEX GmbH

Degree: Approbation, TU Braunschweig

Hannover, Germany

Skills

Arzneimittelzulassung
Projektmanagement
Regulatory Compliance
SmPC (Summary of Product Characteristics)
Company Core Data Sheet (CCDS)
RA Audits und Inspektionen
Sorgfalt/Genauigkeit
Zuverlässigkeit
Organisationstalent
RA Training
RA intelligence
RA Projektmanagement
Beratung
RA Unterstützung für Mergers und Akquisitionen

Timeline

Professional experience for Beate Sonntag

  • Current , since Feb 2019

    Geschäftsführer / Regulatory Affairs Consultant

    SORAPEX GmbH

    Regulatory Affairs Consultancy für Humanarzneimittel /Unterstützung bei Zulassungsprojekten

  • Current , since Oct 2014

    Regulatory Affairs Consultant for Pharmaceuticals

    Selbständig, Freiberuflerin

  • 2 years, Apr 2012 - Mar 2014

    Regulatory Affairs Consultant Schwerpunkt Global labeling

    SORAPEX Ltd

    Regulatory Affairs consultancy for dedicated Service in European Regulatory Affairs medicinal product labeling projects, e.g: • Labeling alignment Projects • Labeling organization, processes, policies and tools • Labeling compliance for inspections and audits • Optimization of Core labeling (CCDS or Master SmPC) • Regulatory Intelligence and Trainings

  • 1 year and 11 months, Sep 2009 - Jul 2011

    Associate Director Regulatory Affairs Labelling, Established Products Division

    Abbott Products GmbH

    Integration der Global Labeling Organization in die Abbott Prozesse/Organisation bei gleichzeitiger Fortsetzung sämtlicher RA labelling Zulassungsaktivitäten für das gesamte Produktportfolio;

  • 2 years and 8 months, Jan 2007 - Aug 2009

    Head of Global Regulatory Affairs Labelling

    Solvay Pharmaceuticals GmbH

    Head of Global Regulatory Affairs Labelling

  • 2 years and 4 months, Oct 2004 - Jan 2007

    Global Deputy Director Regulatory Liaison

    Solvay Pharmaceuticals GmbH

    Head of European Regulatory Affairs Liaison Advise RA management and liaison staff on regulatory affairs topics Acting as the Secretary of the Global Labelling Committee RA integration for business acquisitions (Fournier, Neopharma)

Educational background for Beate Sonntag

  • 5 years and 3 months, Apr 1986 - Jun 1991

    Pharmazie

    TU Braunschweig

Languages

  • German

    First language

  • English

    Fluent

  • French

    Basic

  • Spanish

    Basic

Wants

Neue Herausforderungen
Neue Projekte in Regulatory Affairs Labeling
Neue Projekte in Regulatory Affairs
Neue Projekte in EU Regulatory Affairs

Interests

Sport: Rad fahren
Volleyball
Lesen
Reisen
Tennis

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