À propos de Sylia
Pharmacist (PharmD) – Regulatory & Clinical Affairs Expert
Regulatory Affairs expert in medical devices and pharmaceutical products, with strong expertise in the preparation, authoring, and submission of technical documentation for CE marking under MDR (EU) 2017/745, as well as in ensuring global regulatory compliance (EU, FDA, Canada, China, Japan).
Proven experience in complex projects involving Class IIb, Class III, and Class III combined medical devices incorporating medicinal substances.
Extensive experience in clinical activities, including clinical strategy development and management of clinical evaluation documentation (CER, PMCF), particularly for high-risk and combination devices.
Extensive experience in managing CTD dossiers for combined products as well as DMF dossiers.
Recognized for scientific rigor, strong regulatory expertise, and the ability to support efficient and compliant market access.
Français
Bilingue ou natif
Anglais
Capacité professionnelle complète
Espagnol
Notions
Arabe
Bilingue ou natif
Accepte de travailler sur site
Annecy (jusqu’à 50 km), Genève (jusqu’à 10 km), Lyon (jusqu’à 10 km), Lausanne (jusqu’à 10 km)
Expériences
- AraymondlifeRegulatory Affairs Consultant – Medical Devices and Primary Packaging for Injectable DrugsINDUSTRIE PHARMACEUTIQUEfévrier 2025 - Aujourd'hui (1 an et 4 mois)Voreppe, France- Led regulatory strategy for primary packaging of injectable drugs and medical devices under EU,US, Canadian, Chinese, and Japanese regulations and Pharmacopeias.- Regulatory and Standards watch- Management and submission of DMFs (Drug Master File) in CTD format in the US, Canada, and China.
- PRODIMEDRegulatory Affairs and Clinical Consultant -Gynecological product (class III)/combined devicesINDUSTRIE PHARMACEUTIQUEavril 2023 - février 2025 (1 an et 10 mois)- Writing and updating CE marking technical files for the transition from 93/42/EEC directive to EU regulation 2017/745.- Project lead for the writing of the regulatory dossier on drug substance with an ancillary action in class III medical devices (CTD Format).- Answering the notified body’s questions.- Clinical Project lead (Identification of clinical strategy, clinical file review: CER, CEP and PMCF).- Regulatory watch and gap analysis
- Laboratoires VivacyRegulatory Affairs Specialist – Aesthetic products & Medical Devices (class III)INDUSTRIE PHARMACEUTIQUEoctobre 2022 - mars 2023 (5 mois)Archamps, France- Writing and updating of CE marking technical files according to 93/42/CEE directive and EU 2017/745regulation.- Change control : Assessment of regulatory impact.- Lead of risk management activities.- Review and validation of clinical evaluation and biocompatibility documents.
Recommandations
Soyez le premier à recommander Sylia
Contribuez à la réussite de ce freelance en partageant votre expérience de collaboration avec lui.
Ces profils de freelance correspondent également à vos critères
Agatha Frydrych
Backend Java Software Engineer
4.7
(3)
2
Baptiste Duhen
Fullstack developer
4.6
(4)
5
Amed Hamou
Senior Lead Developer
4
(2)
7
Audrey Champion
Web developer
4.3
(3)
4
Formations
- Master 2 Medical Devices from Design to MarketUniversité de Montpellier2020Medical Device Regulation
- Master 2 Development of Health Products: Human Drugs and Medical DevicesUniversity of Limoges2019
Compétences
Catégories
- Autre