Zoi Chatzisalata

Regulatory Affairs Associate at Medochemie Ltd
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Contact Information
us****@****om
(386) 825-5501
Location
Greece, GR
Languages
  • English Limited working proficiency
  • Greek Native or bilingual proficiency
  • French Elementary proficiency

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Bio

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Credentials

  • Stability Testing of Pharmaceuticals
    Keynotive
    Sep, 2021
    - Nov, 2024
  • EN ISO/IEC 17025:2005
    ΚΕΔΙΒΙΜ Α.Π.Θ.
    Jan, 2018
    - Nov, 2024
  • Cambridge International Diploma in IT Skills (Electronic Communication, Spreadsheets, Presentations, Word Processing, Databases)
    Cambridge University Press
    May, 2008
    - Nov, 2024

Experience

  • Medochemie Ltd
    • Cyprus
    • Pharmaceutical Manufacturing
    • 500 - 600 Employee
    • Regulatory Affairs Associate
      • Mar 2022 - Present

      Prepare CMC (m3) documentation and some parts of administrative documentation (m1) for regulatory submissions for new products and upgrades for the already existing products in compliance with ICH, EMA & global requirements. -New registrations -Variations -Renewals -Deficiency letters -Pre & Post approval -Eu & non eu countries -Pharmaceutical form: tablets & capsules Prepare CMC (m3) documentation and some parts of administrative documentation (m1) for regulatory submissions for new products and upgrades for the already existing products in compliance with ICH, EMA & global requirements. -New registrations -Variations -Renewals -Deficiency letters -Pre & Post approval -Eu & non eu countries -Pharmaceutical form: tablets & capsules

  • DEMO Pharmaceuticals S.A.
    • Greece
    • Pharmaceutical Manufacturing
    • 500 - 600 Employee
    • Regulatory affairs CMC Officer
      • Mar 2020 - Mar 2022

      Prepare CMC documentation for regulatory submissions in line with ICH & EMA guidelines. -New registrations -Variations -Renewals -Deficiency letters -Pre & Post approval -Eu & non eu countries -Pharmaceutical form: powder for solution for injection/infusion, solution for injection/infusion -Module 1, eCTD manager, CESP (Greece) -SAP system Prepare CMC documentation for regulatory submissions in line with ICH & EMA guidelines. -New registrations -Variations -Renewals -Deficiency letters -Pre & Post approval -Eu & non eu countries -Pharmaceutical form: powder for solution for injection/infusion, solution for injection/infusion -Module 1, eCTD manager, CESP (Greece) -SAP system

  • Food Industry "Regina" Kourantidis Chr. Nikolaos
    • Quality Control Chemist
      • Feb 2018 - Mar 2019

      -ISO 2200 and IFS documents-Production process control and cleanliness-Εmployee training (hygiene, safety)

    • Chemist
      • Mar 2017 - Feb 2018

      -Chemical analysis in Honey (raw materials, finall products)-HPLC, Brix meter, pH meter, Spectrophotometer, conductivity analysis-Collaboration with companies for samples analysis in and out of Greece

  • ASQ - World Headquarters
    • United States
    • Non-profit Organizations
    • 200 - 300 Employee
    • ASQ LMC Greece (AUTH SB) Communication Chair
      • Feb 2016 - Sep 2016

  • Del Monte Foods, Inc.
    • United States
    • Food and Beverage Services
    • 700 & Above Employee
    • Assistant Chemist
      • Jun 2015 - Aug 2015

      -Final products' sampling every hour -Gross and net weight -Τemperature measurement and adjustment -Brix meter -Daily documents -Water analysis -Final products' sampling every hour -Gross and net weight -Τemperature measurement and adjustment -Brix meter -Daily documents -Water analysis

Education

  • Aristotle University of Thessaloniki (AUTH)
    Master’s Degree, Environmental Chemistry
    2016 - 2019
  • Aristotle University of Thessaloniki (AUTH)
    Bachelor’s Degree
    2009 - 2015

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