Kassandra LEBOUCHER

Regulatory Affairs Strategist – mRNA vaccines Sanofi - • Supported operational and compliance activities for assigned regulatory deliverables and developed regulatory submission planning for pre-IND meeting, IND and pre marketed product lifecycle management requirements such as DSUR and CSR to FDA. • Liaised and lead cooperation with non-clinical, clinical, medical, supply functions, and other internal business stakeholders to enable successful regulatory outcomes ensuring preparation meet the project timelines for phase I/II clinical trial initiation in the US and Australia. • Developed and monitored strategic input through participation in appropriate governance committees by identifying regulatory risks and proposing mitigations adapted to an accelerated regulatory environment.

Apprenticeship Regulatory Affairs CMC – Pre-AMM vaccines Sanofi - • Involvement in the management and coordination of the strategy and the progress of the provision of CMC documents (including IMPD) required in the context of an accelerated process for submitting a phase III clinical trial application for a new vaccine in international countries. • Preparation and anticipation of a clinical trial application submission for a new vaccine in Europe (EMA) with the CTIS platform • Authoring and updating of a regulatory dossier (CTD) Module 3, 2.3 with modification of the control profile of a Drug Product in order to respond to a Post Approval Commitment (EMA) with a Type II variation.

Internship Regulatory Affairs CMC – Post-AMM vaccines Sanofi 6 months - • Involvement in the regulatory assessment of industrial changes for international countries within the Vaccines entity at Global • Analysis of international guidelines and implementation of internal analysis tools (Veeva Vault)