Carole Lasserre

- CMC regulatory strategy from Ph 1 to MAA (NCE, NBE & known molecules) - Coordination / writing of CMC IMPD & Module 3 / 2.3 / Briefing documents (US/EU) : Europe/US/Export - Coordination / writing of non-clinical IMPD Collaboration with R&D teams : CMC, Pk, Tox, - Regulatory Affairs - QA - Program manager and manufacturing sites

Compliance project: RCD (Regulatory Compliance Document) : Elaboration of a document to highlight differences in Module 3 (Worldwide or ) and facilitate the compliance work. - Project Managment : project presentation and objective, proposition of RCD process - Evaluation of the compliance for the top priority products with action plan to fill the gaps identified. - Writing of variations to fill the gaps and harmonize the dossiers - Writing of the quality documents to describe the compliance management process

- R-CMC team management, planning and priorities - Management of dossier subcontracting - R-CMC LCM (Life Cycle Management) strategy - Change Control evaluation - Collaboration with the different teams of the production site

- Writing of CMC variation files DS/DP ( variations type IA, IB, II), CTD dossiers (Module 3 and 2.3) and answer to questions - EU and Worldwide Area. - MA Renewal management -Regulatory compliance

- HPLC and UPLC method development and validation for vitamin B12 in IPC samples. - Collaboration with manufacturing and QC teams. - Writing of protocol and validation reports.

- Subject: “Feasibility study of the detection of the non-covalent interactions between a protein and an inhibitor peptide by mass spectrometry” - Use of mass spectrometer ESI et nano-ESI Q-TOF

- Development and validation of HPLC analytical methods, stability studies