Doina Serban

Angestellt, Regulatory Affairs Manager, Sandoz, Kundl, Austria
Basel, Switzerland

Fähigkeiten und Kenntnisse

Quality Compliance and Regulatory in Pharmaceutica
Change Control and variations
Pharmaceutical Industry

Werdegang

Berufserfahrung von Doina Serban

  • Current 10 years and 3 months, since Mar 2016

    Regulatory Affairs Manager

    Sandoz, Kundl, Austria

    Manager for mantainance for diffrent products manufactured by Sandoz.

  • 4 years and 11 months, Apr 2011 - Feb 2016

    Quality Compliance responsible for connection to regulatory departments

    Sandoz SRL, Targu-Mures, Romania

    Change Control manager, responsible with Change Control system and implementation of variations. Responsible for providing requested documents for submissions, to check the approvals and to implement the approved variations.

  • 6 years and 2 months, Mar 2005 - Apr 2011

    Drug regulatory affairs specialist

    Gedeon-Richter Romania

    Drug regulatory specialist mostly for new registrations, variations and deficiency letter for Authorities from different countries (from E-Europe).

  • 5 years, Apr 2000 - Mar 2005

    Head of packaging department for tablets

    Gedeon-Richter, Romania

    Organize of activities in Packaging department for tablets.

  • 5 years and 1 month, Mar 1995 - Mar 2000

    Marketing Department specialist

    SICOMED SA, Bucharest, Romania, today Sanofi

    : Performing documentation for export of tablets, contract negotiation

Ausbildung von Doina Serban

  • 4 years and 10 months, Sep 1980 - Jun 1985

    Chemical equipments

    Polytechnic University, Faculty Equipment and Engineering of Chemical Processes

    chemical engineer

Sprachen

  • English

    C1 (Fließend)

  • German

    B1-B2 (Gute Kenntnisse)

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