Víctor Fernández Pons

Regulatory Affairs Officer at ELM Pharmaceutical Consultancy and pharmacovigilance
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Contact Information
us****@****om
(386) 825-5501
Location
ES
Languages
  • Catalan Native or bilingual proficiency
  • Spanish Native or bilingual proficiency
  • English Professional working proficiency
  • French Professional working proficiency

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Bio

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Experience

    • Spain
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Officer
      • Apr 2023 - Present

    • Spain
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs & Quality Assurance Specialist
      • Sep 2022 - Mar 2023

      - Prepare and manage the technical and administrative documentation necessary for the registration of active ingredients, preparing and updating the registration files. - Compile information and plan and implement the necessary actions for the registration of the products. - Prepare and submit dossiers (DMFs) to regulatory authorities. - Communicate with regulatory authorities and monitor possible requirements. - Communicate and coordinate the registration with the client who owns the commercial authorization. - Review and maintenance of technical documentation. - Collaborate in the tasks of the Quality Assurance department. Show less

    • Spain
    • Wellness and Fitness Services
    • 1 - 100 Employee
    • QHSE - Regulatory Affairs Specialist
      • Jun 2021 - Dec 2021

      Quality and Environmental managementRegulatory affairs Logistics supportAccounting support

    • Quality and Regulatory Affairs Specialist
      • Sep 2019 - Jun 2021

      My role in DR Healthcare is to implement/maintain the ISO standards of quality management (9001:2015) and environmental management (14001:2015) and also to give regulatory, administrative and sales support.

  • BioRes
    • Liège Area, Belgium
    • Research Assistant
      • Sep 2018 - Jan 2019

    • Research Assistant Internship
      • Jan 2018 - Apr 2018

  • Institut de Biotecnologia i Biomedicina
    • Cerdanyola Del Valles, Catalonia, Spain
    • Research Assistant Internship
      • Feb 2017 - May 2017

  • Institut de Biotecnologia i Biomedicina
    • Cerdanyola Del Valles, Catalonia, Spain
    • Research Assistant Internship
      • Feb 2016 - Jul 2016

  • Institut de Biotecnologia i Biomedicina
    • Cerdanyola Del Valles, Catalonia, Spain
    • Research Assistant Internship
      • Feb 2015 - Jul 2015

Education

  • Universitat Autònoma de Barcelona
    Bachelor's degree, Microbiology
    2013 - 2017
  • Alison
    Essentials of European Medical Device Regulations (EU MDR) - 2017/745
    2022 - 2022
  • Alison
    ISO 13485:2016 - Quality Management Systems for Medical Devices
    2022 - 2022
  • Alison
    ISO 14971:2019 - Risk Management Application on Medical Devices
    2022 - 2022
  • SGS Academy
    Auditoría
    2018 - 2018
  • SGS Academy
    GMP
    2020 - 2020

Community

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