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Servier Laboratories Ireland Ltd.
- Regulatory Affairs Associate
Suresnes
2016 - maintenant
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Arkopharma
- Regulatory Affairs Coordinator (Medicinal products / Medical Devices)
Carros
2012 - 2016
• Medicinal products (Drugs, Herbal drugs and Homeopathy):
- Regulatory evaluation for new product development and life cycle management (variations, renewals).
- Redaction of module 3 of the CTD (CMC) for new MA and variation applications.
- Coordinate elaboration of technical files (modules 1 to 5 of the CTD).
- Submission to Health Authorities of MA applications, variations (Quality, Safety) and renewals. Planning and tracking of submissions. Follow up with authorities. Coordinate the preparation of responses to questions.
- Regulatory review of product information (SmPC, labelling, PIL) and advertising material.
- Regulatory intelligence.
• Medical devices (Class I and IIa)
- Writing, compilation and maintenance of CE technical files.
- Coordination and oversight of risk analysis meetings (ISO 14971).
- Submission of and follow-up on CE technical files with notified bodies.
- Portfolio management, review of labelling and advertising material, regulatory intelligence.
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Sanofi Pasteur
- Regulatory Affairs Internship
Lyon
2011 - 2012
Regulatory Affairs – CMC Global Projects:
Elaboration of a global regulatory strategy for manufacturing site transfers (grouping of variations by centralized, MRP and national procedures). Survey of international countries specific to manufacturing site transfers.
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Sanofi Pasteur
- Regulatory Affairs Training
Lyon
2011 - 2011
Regulatory Affairs – Clinical and Preclinical Development
- Support for clinical and preclinical parts in the submission of a Repeat Use Procedure (MRP). Elaboration of modules 4 and 5 with reformatting from NTA to CTD format.
- Gap analysis of the new WHO prequalification vaccines process.
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Hôpital Neurologique Lyon Est - Centre de Médecine Nucléaire
- Hospital internship - full-time (5ème année Hospitalo-Universitaire)
2010 - 2011
Nuclear medicine care service:
Retrospective study on long-term predictability of a thyroid cancer marker (thyroglobulin).
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Hospices Civiles de Lyon
- Hospital internship - half-time (Externe en pharmacie)
2008 - 2010
- Biology center (Centre de biologie et de pathologie du Groupement Hospitalier Est)
- Hematology laboratory (Laboratoire d’hématologie de l’hôpital de la Croix-Rousse)
- Immunology laboratory (Laboratoire d’immunologie du Centre Hospitalier Lyon Sud)
- Hospital pharmacy (Pharmacie hospitalière de l’Hôpital Edouard Herriot)
