Dr. Julia Wiedemann

Angestellt, Head of Regulatory Affairs, Strathmann GmbH & Co. KG
Hamburg, Germany

Fähigkeiten und Kenntnisse

MAA in EU and RoW
CMC
DL EU/RoW
determination
team player
analytical thinking
flexibility
organising ability
attention to detail
Regulatory Affairs
Scientific Affairs
analytic method validation
shelf life extrapolation
scientific communication with customers
scientific communication with DS and DP manufactur
CEP updates
CEP revisions
ASMF compilation
dossier compilation
Lifecycle Management
MRP/DCP
national phases EU
analytical method development
clinical overview compilation
GMP audit
Report
ability to work under pressure
Kommunikationsfähigkeit
Leadership skills
Responsible
Commitment
Intercultural competence
Fast learner
willingness to learn
willingness to travel
Professional experience
problem solving skills
hands-on mentality
Systems Thinking
Scientific advices
Herbal medicinal products
Small molecules
Allergen products
Vaccines
Molecular Biology
Biochemistry
Pharmaceutical industry
Research and Development
Cell Biology
Product Registration
Drug Development
Drug Manufacturing
Project Management
English Language
Biology
punctual
Enthusiasm
Motivation
persuasive

Werdegang

Berufserfahrung von Julia Wiedemann

  • Current 6 years and 9 months, since Sep 2019

    Head of Regulatory Affairs

    Strathmann GmbH & Co. KG

  • 2 years and 1 month, Jul 2022 - Jul 2024

    Head of Regulatory Affairs North

    Allergopharma GmbH & Co. KG und Strathmann GmbH & Co. KG

  • 2 years and 10 months, Dec 2016 - Sep 2019

    CMC Manager

    Klosterfrau Berlin GmbH

  • 1 year and 2 months, Nov 2015 - Dec 2016

    Auditor

    Fair-Med Healthcare GmbH

    cGMP auditor

  • 1 year and 7 months, Jun 2015 - Dec 2016

    Head of Regulatory & Scientific Affairs

    Fair-Med Healthcare GmbH

  • 1 year and 9 months, Oct 2013 - Jun 2015

    Regulatory Affairs (Trainee)

    Helm AG, Hamburg

  • 8 months, Oct 2012 - May 2013

    Postdoctoral Fellow in Patholgy and Laboratory Medicine

    Medical University of South Carolina

  • 3 years and 9 months, Jan 2009 - Sep 2012

    Ph.D. student/ Doktorandin

    Medical University of South Carolina

  • 11 months, Feb 2008 - Dec 2008

    Trainee in Biochemistry and Molecular Biology

    Medical University of South Carolina

  • 11 months, Jun 2007 - Apr 2008

    Diplomandin

    Humboldt-Universität zu Berlin

  • 11 months, Jun 2007 - Apr 2008

    Diplomandin

    Max-Planck-Institut für Infektionsbiologie

  • 1 year and 4 months, Oct 2006 - Jan 2008

    Studentische Hilfskraft

    Max-Planck-Institute for Infection Biology

Ausbildung von Julia Wiedemann

  • 3 years and 9 months, Jan 2009 - Sep 2012

    Biochemistry and Mol Biology

    Medical University of South Carolina/ University of Hamburg

    RNA-, protein- and cell biology in vitro SUMOylation, EMSAs

  • 3 years and 6 months, Oct 2004 - Mar 2008

    Biologie

    Humboldt Universität/ MPI for Infectious diseases and immunology

    Biochemie, Molekularbiologe/ Genetik, Immunologie

Sprachen

  • English

    C1 (Fließend)

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • French

    A1-A2 (Grundkenntnisse)

  • Arabic

    A1-A2 (Grundkenntnisse)

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