Dr. Stephanie Krumholz

Vorstandsmitglied, General Manager, NDA Regulatory Service Switzerland GmbH

Zürich, Schweiz

Fähigkeiten und Kenntnisse

Unique combination of Drug Regulatory Affairs and
US
EU
rest of the world
including China
Japan
Regulatory Intelligence
Health Authority Meetings
Clinical Studies
Phase I-IV Drug pre filing
regulatory filing and post filing activities
different therapeutic areas (CNS
metabolic
oncology
anemia
asthma
inflammation
orphan drugs
CNS)
Project Management
Matrix management (up to 25 people)

Werdegang

Berufserfahrung von Stephanie Krumholz

  • Bis heute 9 Jahre und 5 Monate, seit Jan. 2015

    General Manager

    NDA Regulatory Service Switzerland GmbH

  • 5 Monate, Aug. 2014 - Dez. 2014

    Managing Director

    Stephanie Krumholz Life Sciences Consulting GmbH

  • 1 Jahr und 3 Monate, Mai 2013 - Juli 2014

    Head of Regulatory Affairs, Director

    Cytos Biotechnology AG

    Responsible for all regulatory affairs interactions between Cytos & Regulatory Agencies (FDA, Europe). Develop a global regulatory strategy, including budgeting. Advise as member of the corporate quality management committee. Implement a new document management system. Built up the regulatory function.

  • 1 Jahr und 7 Monate, Apr. 2011 - Okt. 2012

    Secondment- Roche Partnering

    F.Hoffmann-La Roche

  • 2 Jahre und 4 Monate, Jan. 2010 - Apr. 2012

    Global Regulatory Leader

    F. Hoffmann-La Roche

  • 2007 - 2009

    Associate Director Regulatory Affairs

    F. Hoffmann-La Roche Ltd.

  • Research Assistant

    Humboldt University; Charite Berlin

  • Part-Time Pharmacological Consultant

    Peppermint. Financial Partners

  • Pharmacist

    Pharmacies

  • Pharmacist Trainee

    LTS Lohmann Therapy Systems Corporation

Ausbildung von Stephanie Krumholz

  • Dr. rer medic.

    Humboldt University

    Charite Berlin, Department of Obstetrics, Ph.D

  • Pharmacy

    University of Bonn, Germany, Pharmacy

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Spanisch

    Grundlagen

  • Französisch

    Gut

  • Koreanisch

    Grundlagen

Interessen

Non for profit organization

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