Víctor Fernández Pons
Regulatory Affairs Officer at ELM Pharmaceutical Consultancy and pharmacovigilance- Claim this Profile
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Catalan Native or bilingual proficiency
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Spanish Native or bilingual proficiency
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English Professional working proficiency
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French Professional working proficiency
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Bio
Experience
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ELM Pharmaceutical Consultancy
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Spain
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Officer
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Apr 2023 - Present
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OCB Pharmaceutical
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Spain
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs & Quality Assurance Specialist
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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
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DR HEALTHCARE
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Spain
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Wellness and Fitness Services
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1 - 100 Employee
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QHSE - Regulatory Affairs Specialist
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Jun 2021 - Dec 2021
Quality and Environmental managementRegulatory affairs Logistics supportAccounting support
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Quality and Regulatory Affairs Specialist
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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.
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BioRes
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Liège Area, Belgium
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Research Assistant
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Sep 2018 - Jan 2019
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Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
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Spain
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Research Services
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200 - 300 Employee
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Research Assistant Internship
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Jan 2018 - Apr 2018
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Institut de Biotecnologia i Biomedicina
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Cerdanyola Del Valles, Catalonia, Spain
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Research Assistant Internship
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Feb 2017 - May 2017
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Institut de Biotecnologia i Biomedicina
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Cerdanyola Del Valles, Catalonia, Spain
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Research Assistant Internship
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Feb 2016 - Jul 2016
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Institut de Biotecnologia i Biomedicina
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Cerdanyola Del Valles, Catalonia, Spain
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Research Assistant Internship
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Feb 2015 - Jul 2015
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Education
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Universitat Autònoma de Barcelona
Bachelor's degree, Microbiology -
Alison
Essentials of European Medical Device Regulations (EU MDR) - 2017/745 -
Alison
ISO 13485:2016 - Quality Management Systems for Medical Devices -
Alison
ISO 14971:2019 - Risk Management Application on Medical Devices -
SGS Academy
Auditoría -
SGS Academy
GMP