Regulatory Affairs Consultant at Umanis (01-2015 to 10-2022), then at CGI-Umanis from 10-2022.Mission at Sanofi Pasteur (Marcy l'Etoile, 69, France), pharmaceutical company, vaccines for human use.- Writing and submission of regulatory dossiers (administrative documents, ctd amendment, modules 2 and 3) for registration of new products and CMC variations in Europe, USA, Canada and at the International area.- writing of answers to questions (module 3, CMC) from Health… Show more Regulatory Affairs Consultant at Umanis (01-2015 to 10-2022), then at CGI-Umanis from 10-2022.Mission at Sanofi Pasteur (Marcy l'Etoile, 69, France), pharmaceutical company, vaccines for human use.- Writing and submission of regulatory dossiers (administrative documents, ctd amendment, modules 2 and 3) for registration of new products and CMC variations in Europe, USA, Canada and at the International area.- writing of answers to questions (module 3, CMC) from Health Authorities.- renewals (CMC part)- interactions with industrial affairs (manufacturing, control) and development (manufacturing and analytical) Show less

03-2014 to 12-2014: Mission at Sanofi Pasteur (Marcy l'Etoile, 69, France), pharmaceutical company, vaccines for human use.- writing and submission of dossier (administrative documents, ctd amendment, labeling, packaging, modules 2 and 3) for registration of a new product in France, Europe and at the International area.- writing of answers to questions (module 3, CMC) from Health Authorities.09-2013 to 11-1013: Mission at Mylan (Saint-Priest, 69, France), pharmaceutical company,… Show more 03-2014 to 12-2014: Mission at Sanofi Pasteur (Marcy l'Etoile, 69, France), pharmaceutical company, vaccines for human use.- writing and submission of dossier (administrative documents, ctd amendment, labeling, packaging, modules 2 and 3) for registration of a new product in France, Europe and at the International area.- writing of answers to questions (module 3, CMC) from Health Authorities.09-2013 to 11-1013: Mission at Mylan (Saint-Priest, 69, France), pharmaceutical company, generic drugs for human use, retail and hospital. - Writing and submission of dossiers (administrative documents and module 3) for product registration at Export.- Writing of pharmaceutical variations (module 3) at Export.04-2013 to 08-2013: Mission at ARROW Génériques (Lyon, 69, France), pharmaceutical company, generic drugs for human use, retail and hospital.- Writing pharmaceutical variations; Creation and validation of the Annex to Marketing Authorizations (SmPC, leaflet) and packaging items (artworks).03-2013 to 04-2013: Mission at Richard Frères SA (Saint-Etienne, 42, France)- Realization of CE marking dossiers for class I medical devices (orthesis: knee, ankle) Show less

Job as a consultant at Mylan France, pharmaceutical company, generic drugs for human use, retail and hospital. . - writing and submission of pharmaceutical and clinical variations (France and Export countries),- analysis of SmPCs according to the European Pharmacovigilance regulation (Addendum Clinical Overview),- compilation and integration of regulatory data in two new databases for many strengths/packaging of generic drugs for human use, including retail (affiliate), hospital… Show more Job as a consultant at Mylan France, pharmaceutical company, generic drugs for human use, retail and hospital. . - writing and submission of pharmaceutical and clinical variations (France and Export countries),- analysis of SmPCs according to the European Pharmacovigilance regulation (Addendum Clinical Overview),- compilation and integration of regulatory data in two new databases for many strengths/packaging of generic drugs for human use, including retail (affiliate), hospital (global) and export.To achieve these goals, I prioritized tasks, and performed a transversal management, a time management, in compliance with deadlines. Show less

Writing and submission of Labeling Changes in accordance with the French Health Authority (ANSM) and with European procedures (Guidelines, QRD). Validation of labeling documents submitted in the International area, both on products marketed and products in last phase of their development.Proposal for modification / optimization of internal processes.Collaboration with Regulatory Product Managers, Regulatory Area Leaders, Regulatory located abroad, as well as the company SPMSD.

Professional training to bio-companies (IPROB, Lyon)Introduction to trades and skills of companies by professionals (Pharma, MD, IVD, Biotechs, Consulting).Regulatory and clinical affairsProject ManagementQualityIndustrial PropertyMarketing.

R&D postdoctoral fellow - laboratory UMR 6098 CNRS - Marseille University 'AFMB: Architecture and function of biological macromolecules' (team of Pr GUILLEMOT)Project: Study of structural and functional replicative complex of dengue virus.Establishment of sub-genomic replicons; development of a cellular fluorescent screening test of antivirals, identification and characterization of inhibitors of the viral polymerase in a cellular context, characterization of monoclonal antibodies to… Show more R&D postdoctoral fellow - laboratory UMR 6098 CNRS - Marseille University 'AFMB: Architecture and function of biological macromolecules' (team of Pr GUILLEMOT)Project: Study of structural and functional replicative complex of dengue virus.Establishment of sub-genomic replicons; development of a cellular fluorescent screening test of antivirals, identification and characterization of inhibitors of the viral polymerase in a cellular context, characterization of monoclonal antibodies to three viral proteins replicative.Development: 5 publications (3 published, 2 in preparation), two international communications. Show less

Biology PhD (INSERM, Lyon, supervisor: Dr BUCKLAND)Project: Structure-function relationships of the glycoprotein attachment of measles virus.Identification of molecular determinants of interaction between viral hemagglutinin and cellular receptors.Development: 2 posters, 2 international communications.