Sofia Bellakhdar
Regulatory Affairs Specialist at HYPHEN BioMed- Claim this Profile
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Français Native or bilingual proficiency
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Anglais Full professional proficiency
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Bio
Experience
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HYPHEN BioMed
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France
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Specialist
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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
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Curium Pharma
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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Export Regulatory Affairs Officer
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Nov 2018 - Mar 2019
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Scientific and Regulatory Officer
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May 2017 - Oct 2018
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Sanofi
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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Project manager – Customer complaint department - Work-study
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Dec 2015 - Sep 2016
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Université de Cergy-Pontoise
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France
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Spectator Sports
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Control of raw materials (Atropine sulfate) and release of a drug batch (eye drops) - Project
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May 2016 - Jun 2016
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Research assistant - Internship
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Apr 2015 - Jun 2015
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Firmenich
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Switzerland
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Chemical Manufacturing
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700 & Above Employee
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Analytical technician - Internship
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May 2014 - Aug 2014
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Education
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Université de Cergy-Pontoise
Master's degree Quality and Control -
Université de Cergy-Pontoise
Master's degree chemistry, analytical control -
Université de Cergy-Pontoise
Licence, Chemistry