Dr. Christian Pötschke

ist offen für Projekte. 🔎

Angestellt, Manager Regulatory Affairs, Alfred E. Tiefenbacher (GmbH & Co. KG)

Hamburg, Deutschland

Fähigkeiten und Kenntnisse

CMC lifecycle management
postapproval variation
renewal
new submission
Immunology
GMP Compliance
MRP/DCP/CP
small molecule generics
eCTD
generics
lorenz docubridge
SAP
SharePoint
Microsoft-Office-Applications
small molecules
EMA-human regulatory guidelines
CMC
Arzneimittelzulassung

Werdegang

Berufserfahrung von Christian Pötschke

  • Bis heute 3 Jahre, seit Juni 2021

    Manager Regulatory Affairs

    Alfred E. Tiefenbacher (GmbH & Co. KG)

    - Responsibility for Regulatory Affairs issues within project development - Preparation of submission documentation EU and NON-EU, including new submissions, variations and renewals - Direct contact with health authorities and international clients

  • 8 Jahre und 1 Monat, Mai 2013 - Mai 2021

    Senior Regulatory Affairs Manager

    Salutas Pharma GmbH (Sandoz / Novartis Group)

    • CMC life cycle management of small-molecule generics for a wide range of dosage forms with global scope, except US • Cross-functional projects, involving QA, QC, supply and launch teams • Coordinating regulatory activities with customers

  • 6 Jahre und 4 Monate, Sep. 2006 - Dez. 2012

    PhD student and research associate

    Institut für Immunologie, Ernst-Moritz-Arndt Universität

    PhD Thesis: B cell response and humoral memory in murine polymicrobial sepsis • Application for animal testing and communication with authorities • Deputy speaker of the graduate school GRK 840 • Lecturing and supervising diploma and MD students • Building up and supervising flow-cytometry facility

Ausbildung von Christian Pötschke

  • 5 Jahre, Sep. 2001 - Aug. 2006

    Human biology

    Ernst-Moritz-Arndt University Greifswald

    Die Rolle des adaptiven Immunsystems in der Sepsis am Mausmodell.

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Französisch

    Grundlagen

Interessen

Regulatory Affairs
History
Politics
Literature

21 Mio. XING Mitglieder, von A bis Z