Michael Dr Jandke
Skills
Timeline
Professional experience for Michael Dr Jandke
- Current 6 years and 11 months, since Apr 2019
EU Head of Regulatory Affairs at Miltenyi Biomedicine
Miltenyi Biomedicine GmbH
EU Head of Regulatory Affairs at Miltenyi Biomedicine; Biotech industry
- 3 years and 3 months, Jan 2016 - Mar 2019
Director Regulatory Affairs
Codon AG
Active working contribution which successfully resulted in the granting of the marketing authorisation for the Tissue Engineered Product (TEP-ATMP) “Spherox” in the EU and Switzerland Implementation at Codon AG of an eCTD tool (Docubridge One, Lorenz) for in – house compilations Renewal SME status
- 2 years and 9 months, Apr 2013 - Dec 2015
Regulatory Affairs Manager
Cytonet GmbH
Principal Project coordinator for CMC for a somatic Cell-Based product (sCTP-ATMP) across the manufacturing site Durham,NC (USA) and Quality control department in Heidelberg (Germany) Active CMC - contributor towards the MAA (Centralised Procedure) for Hepatic Urea Cycle Disorders, in children & newborns
Educational background for Michael Dr Jandke
- 4 years and 10 months, Oct 1993 - Jul 1998
Pharmacy
Humboldt-Universität zu Berlin
Languages
English
Fluent
Spanish
Basic
German
First language
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