Alfonso Lomas

International Regulatory Affairs Manager, PV Coordinator & Materiovigilance Responsible at MANA PHARMA, S.L.
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Contact Information
us****@****om
(386) 825-5501
Location
ES
Languages
  • English Full professional proficiency
  • Italian Professional working proficiency
  • Spanish Native or bilingual proficiency

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Credentials

  • Actualización en Buenas Prácticas de Distribución Farmacéutica
    Consejo General de Colegios Farmacéuticos
    Oct, 2022
    - Oct, 2024
  • Certificate in Advanced English (C1)
    University of Cambridge
  • First English Certificate (B2)
    University of Cambridge
  • Italiano Livello B2
    Università degli Studi di Firenze
  • Preliminary English Test (B1)
    University of Cambridge

Experience

    • Spain
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • International Regulatory Affairs Manager, PV Coordinator & Materiovigilance Responsible
      • Jan 2023 - Present

    • International Regulatory Affairs Technician, PV Coordinator & Materiovigilance Responsible
      • Jul 2022 - Jan 2023

      • Management of the registration procedure for medicines in LATAM and MEA.• Preparation, management and presentation of variations, renewals and other procedures to ensure the maintenance of registrations.• Support in external audits.• Coordination and direct contact with clients, suppliers and corresponding authorities.• Revision and translation of registration materials.• Participation in projects development, ensuring compliance with regulatory requirements applicable in each territory.• Revision and filing of pharmacovigilance documentation.• Coordination of pharmacovigilance activities.• Revision and translation of web and advertising materials. Show less

    • Spain
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Member
      • 2022 - Present
    • Spain
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs, Quality Assurance & Pharmacovigilance Technician
      • Jul 2021 - Jul 2022

      • Support in the creation of a new QA system from scratch. • Revision and creation of new SOPs. • Registration in the different product categories in the CAM. • Adaptation and revision of AWs for all products. • Support in the creation of a new QA system from scratch. • Revision and creation of new SOPs. • Registration in the different product categories in the CAM. • Adaptation and revision of AWs for all products.

    • Pharmacist
      • Apr 2020 - Aug 2021
    • Pharmacist
      • May 2019 - Jul 2019
    • Spain
    • Medical Practices
    • 1 - 100 Employee
    • Pharmacist
      • Feb 2019 - Apr 2019

Education

  • CESIF
    Master's degree, Industria Farmacéutica y Parafarmacéutica
    2019 - 2020
  • Università degli Studi di Firenze
    Grado en Farmacia, Servicios sanitarios/Ciencias de la salud, general
    2017 - 2018
  • Universidad de Granada
    Grado en Farmacia, Servicios sanitarios/Ciencias de la salud, general
    2014 - 2019
  • IES Puerta de Arenas
    Bachelor's degree, Servicios sanitarios/Ciencias de la salud, general
    2012 - 2014

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