Sofia Bellakhdar

Regulatory Affairs Specialist at HYPHEN BioMed
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Contact Information
us****@****om
(386) 825-5501
Location
FR
Languages
  • Français Native or bilingual proficiency
  • Anglais Full professional proficiency

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Bio

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Experience

    • France
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Specialist
      • Mar 2020 - Present

      - Manage submissions, renewals and change submissions files in international and mainly in EMEA region (Middle East, North Africa and Europe out from UE) - Follow request and answer the questions from third parties (affiliates, distributors...) - Participate to the writing of procedures related to the registration activities - Handle databases and archive registration files - Schedule weekly meeting related to the progress activities - Manage submissions, renewals and change submissions files in international and mainly in EMEA region (Middle East, North Africa and Europe out from UE) - Follow request and answer the questions from third parties (affiliates, distributors...) - Participate to the writing of procedures related to the registration activities - Handle databases and archive registration files - Schedule weekly meeting related to the progress activities

    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Export Regulatory Affairs Officer
      • Nov 2018 - Mar 2019

    • Scientific and Regulatory Officer
      • May 2017 - Oct 2018

    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Project manager – Customer complaint department - Work-study
      • Dec 2015 - Sep 2016
    • France
    • Spectator Sports
    • Control of raw materials (Atropine sulfate) and release of a drug batch (eye drops) - Project
      • May 2016 - Jun 2016
    • Research assistant - Internship
      • Apr 2015 - Jun 2015
    • Switzerland
    • Chemical Manufacturing
    • 700 & Above Employee
    • Analytical technician - Internship
      • May 2014 - Aug 2014

Education

  • Université de Cergy-Pontoise
    Master's degree Quality and Control
    2015 - 2016
  • Université de Cergy-Pontoise
    Master's degree chemistry, analytical control
    2014 - 2015
  • Université de Cergy-Pontoise
    Licence, Chemistry
    2013 - 2014

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