Graduated from an biotechnological engineering school, I have background on manufacturing process, identifications, quality, and controls of a pharmaceutical product that allowed me to specialize on Regulatory affair CMC for pharmaceutical product.
I have 5-year experience in Regulatory affair CMC product manager as a consultant within GRA CMC Sanofi on biological team and 2 internships on small molecule products.
I experienced EU, Japan and ROW market regulatory environment specifically on post approval submission, but also on initial marketing authorization dosser. I work on assessing changes control issued by the different sites, providing the impact for each market and working on a strategy of submission for each of them. I coordinate with regulatory based on the different sites and at affiliates level to ensure submission of the dossier. I have good knowledge of M3 and M.2.3, coordinating their preparation and managing M1 documentation. Good knowledge of the international market’s environments.
Also, I was able to work on different types of regulatory projects (CMC variation, Line extension, dossier upgrade, Extension of Territory (TE), Transfer of site, new MAA...), in an international context.
Autonomous in my work and curious, I am interested on challenges, I adapt quite well to new environment and new projects.
I am used to work on diverse project and I am multitasking on a daily basis.
I would like to extend my knowledge with CMC activities but also developping labelling, clinical and non-clinical project.