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Andrea Ramírez

Andrea Ramírez

Followers of Andrea Ramírez360 followers
location of Andrea RamírezJalisco, Mexico

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  • Timeline

  • About me

    Biotechnology engineer - MBA - Regulatory affairs specialist

  • Education

    • Universidad Autónoma de Guadalajara

      2023 - 2023
      Postgraduate Degree Project Management

    • Universidad Autónoma de Guadalajara

      -
      Biotechnology engineer

    • Universidad Autónoma de Guadalajara

      2021 -
      Master in Business Administration

  • Experience

    • PiSA Farmacéutica

      Dec 2020 - now

      Integrate the dossier for new registration, renewal, or modification to registration conditions of sanitary registrations of biosimilar products in Mexico and abroad.Execute, prepare, and review the technical documentation for the entry of the requested regulatory procedures.Organize, review, and assemble Quality, Safety, and Efficacy information in the CTD (Common Technical Document) format.Verify that suppliers comply with regulatory requirements.Provide support and regulatory assistance to the areas that request it.Request verification visits to the authority to obtain the certificate of Good Manufacturing Practices (GMP). Show less

      • Business Intelligence Expert

        Jan 2025 - now

      • Business Intelligence Specialist

        Oct 2023 - Jan 2025

      • Regulatory Affairs Analyst

        Apr 2022 - Oct 2023

      • New Product Introduction Specialist

        Dec 2020 - Apr 2022

  • Licenses & Certifications