profile-img

Sara Mamdouh Lithy

Change Control & Regulatory Experts

Cairo, Egypt

Work Experience

  • Senior Regulatory Site OfficerFull Time

    SANOFI

    Jan 2013 - Present -12 yrs, 5 months

    Egypt , Cairo

    • Job Details: Co-ordination between Industrial Affairs department and DRA department in regulatory aspects of chemistry, manufacturing and control for pharmaceutical products including preparation and dispatch of regulatory dossiers (CMC & CTD)  Assessment and maintenance of regulatory compliance  SMF “Site Master File” maintenance  Management of the change control process and electronic system in Cairo site.  Management of the regulatory activities with the Ministry of Health Inspection Department.
  • Regulatory Affairs SpecialistFull Time

    EIPICo

    Jun 2009 - Dec 2012 -3 yrs, 6 months

    Egypt , Cairo

    • Job Details:Responsible for Local Registration, International Registration and Patent & Rights of Intellectual Property
  • Medical RepresentativeFull Time

    UGP, United Group Pharmaceuticals

    Apr 2009 - May 2009 -1 month

    Egypt , Giza

    • Community PharmacistFull Time

      Projects

      Jul 2008 - Apr 2009 -9 months

      Egypt , Cairo

      • Education

        • Bachelor's Degree in Pharmacy

          Ain Shams University (ASU)

          Jan 2003 - Jan 2008 - 5 yr

        • High School - Thanaweya Amma

          El Khalifa El Maamoun

          Jan 2003 

        Skills

        • Change Control
        • Phenix Electronic system
        • Microsoft Office
        • Regulatory Guidelines
        • CTD
        • Lean Six Sigma
        • GEODE+
        • Basic Selling Skills

        Languages

        • Arabic

          Fluent
        • English

          Fluent
        • French

          Beginner

        Training & Certifications

        • How to prepare a CTD file

          Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances “AUPAM”·2010
        • Adverse Event Reporting

          Pfizer·2010
        • CTD & eCTD Authority Course

          Scientific Office for System & Solution Design·2009
        • CTD & eCTD Manager Basic Course

          Scientific Office for System & Solution Design·2009
        • Uncover Counterfeit and Promotional Claims

          Scientific Office for System & Solution Design”·2009
        • Selecting Unified Product Name

          Scientific Office for System & Solution Design·2009
        • Selling Skills

          UGP, "United group pharmaceuticals"·2009
        Share this Profile