Olga Stratigopoulou

CMC Supervisor at PharOS Ltd
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Contact Information
us****@****om
(386) 825-5501
Location
Greece, GR

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Experience

    • Greece
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • CMC Supervisor
      • Nov 2022 - Present

      Supervise, participate and train a team in the Pre Approval CMC tasks:- Dossier compilation - Dossier registration procedure for DCPs/CPs/MRPs- Medicinal product lifecycle- Clients' support

    • CMC Specialist
      • Apr 2020 - Nov 2022

      - Evaluating Information for Compilation of the Registration Dossier- Coordinating actions required in order to meet deadlines- Data evaluation for compliance with EU-ICH Guidelines- Dossier customization- Providing scientific support for the approval of new medicinal products- Communicating regulatory information to multiple departments

    • Greece
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Supervisor
      • Jan 2020 - Apr 2020

      - Evaluating Information for Compilation of the Registration Dossier- Coordinating actions required in order to meet deadlines- Liaising with Regulatory Authorities (MHRA, FDA) for Submissions & RFIs- Editing of Risk assessment reports - Providing scientific support for the approval of new medicinal products- Communicating regulatory information to multiple departments

    • Regulatory Affairs Officer
      • Aug 2015 - Jan 2020

      - Preparing documents necessary for application, evaluation and approval by competent Authorities- Keeping up-to-date with international legislation, guidelines and practices - Continuous follow-up of ongoing assigned projects- Collecting, collating and evaluating scientific data from a range of sources

    • Pharmacist
      • Jul 2013 - Aug 2015

Education

  • National & Kapodistrian University of Athens
    Master's degree, Industrial Pharmacy
    2012 - 2014
  • National & Kapodistrian University of Athens
    Bachelor's degree, Pharmacy
    2007 - 2012

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