Karsten Krüger

Partner / Gesellschafter, Managing Partner, MAIN5 GmbH & Co. KGaA
Frankfurt am Main, Germany

Fähigkeiten und Kenntnisse

Topics: Regulatory Affairs IT
Regulatory Operations
eCTD
XML
labeling
PIM
CDISC
e-regulations from health authorities
project management
SDLC management
submissions management
submission planning
document management
SOP management
Documentum
CSC FirstDoc
Insight Manager
Labeling Management
SDL Trados
XEVMPD
IDMP
eTMF / TMF
CARA / Generis

Werdegang

Berufserfahrung von Karsten Krüger

  • Current 10 years and 5 months, since Jan 2016

    Managing Partner

    MAIN5 GmbH & Co. KGaA
  • Current 12 years and 8 months, since Oct 2013

    Managing Partner

    MAIN5 GmbH

    MAIN5 represents a Management Consulting company headquartered in Frankfurt delivering measurable results and robust consulting services. MAIN5 focusses the provision of Interim-, Change-, Project- and Compliance Management support within the Life Science sector or associated industries only. This is the domain that the MAIN5 partners and consultants know best to generate sustainable success by solving multifaceted questions and implementing complex projects.

  • 3 years, Oct 2010 - Sep 2013

    Industry Expert / Subject Matter Expert - integrated Drug Regulatory Affairs

    NNIT Switzerland AG

  • 1 year and 6 months, Apr 2009 - Sep 2010

    Unit Manager Pharma R&D

    Logica Business Consulting

  • 16 years and 8 months, Aug 1992 - Mar 2009

    Head of GRO Coordination

    Bayer Schering Pharma AG

    Observation, support and harmonization of publishing, labeling and document management standards and requirements with regard to internal business processes & external health authority guidelines Secure standards and compliance for the usage of applications worldwide Interface with internal / external application providers and Global Regulatory Affairs Translate emerging regulatory technical requirements into IT requirements to drive and facilitate the integration of corresponding applications ...

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    keine

Ausbildung von Karsten Krüger

  • Allgemeine Informatik

    Technische Fachhochschule Berlin

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • French

    A1-A2 (Grundkenntnisse)

  • Turkish

    A1-A2 (Grundkenntnisse)

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