Karsten Krüger

Partner / Gesellschafter, Managing Partner, MAIN5 GmbH & Co. KGaA

Frankfurt am Main, Deutschland

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

  • Bis heute 8 Jahre und 5 Monate, seit Jan. 2016

    Managing Partner

    MAIN5 GmbH & Co. KGaA
  • Bis heute 10 Jahre und 8 Monate, seit Okt. 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 Jahre, Okt. 2010 - Sep. 2013

    Industry Expert / Subject Matter Expert - integrated Drug Regulatory Affairs

    NNIT Switzerland AG

  • 1 Jahr und 6 Monate, Apr. 2009 - Sep. 2010

    Unit Manager Pharma R&D

    Logica Business Consulting

  • 16 Jahre und 8 Monate, Aug. 1992 - März 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 ...

  • ---

    keine

Ausbildung von Karsten Krüger

  • Allgemeine Informatik

    Technische Fachhochschule Berlin

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Französisch

    Grundlagen

  • Türkisch

    Grundlagen

Interessen

my family
traveling
networking

21 Mio. XING Mitglieder, von A bis Z