Amanda Fernandes De Andrade Paiva

Amanda Fernandes De Andrade Paiva

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  • Timeline

  • About me

    Regulatory Affairs and Quality Assurance Manager Latam

  • Education

    • Senai

      -
      Business Administration
    • Faculdades Oswaldo Cruz

      2019 - 2021
      Regulatory affairs specialist
    • Universidade Bandeirante de São Paulo

      2010 - 2014
      Bachelor of Pharmacy - BPharm Pharmacy
  • Experience

    • DKT South America

      Oct 2013 - now

      Regulatory Affairs and Quality Assurance Manager with over 10 years of experience in pharmaceutical company. Technical Skills: Project Management Regulatory Risk Analysis Clear and Effective;Communication In-depth Knowledge of Regulatory Standards;Expertise in developing and implementing regulatory strategies for pharmaceutical and medical device products;Proven ability to obtain regulatory approvals for new product submissionsand maintain compliance with current regulations; Experience in managing regulatory submissions and communicating with regulatory authorities;Skilled in providing regulatory guidance and support to cross-functional teams;Experienced in leading teams and coordinating international projects. Show less

      • Regulatory Affairs and Quality Assurance Manager Latam

        Dec 2023 - now
      • Regulatory Affairs coordinator Latam

        Apr 2022 - Dec 2023
      • Regulatory Affairs analyst Latam

        Jan 2021 - Apr 2022
      • Regulatory Affairs analyst

        Apr 2018 - Dec 2020
      • Quality Assurance Analyst

        Jan 2015 - Apr 2018
      • Customer service assistant

        Oct 2013 - Jan 2017
  • Licenses & Certifications

    • ASPECTOS TÉCNICOS E REGULATÓRIOS RELACIONADOS AO DESENVOLVIMENTO E REGISTRO DE MEDICAMENTOS

      Conselho Regional de Farmácia do Estado de São Paulo
    • FARMACOVIGILÂNCIA

      Conselho Regional de Farmácia do Estado de São Paulo