Dr. Miriam Bougault

Leading a team of regulatory affaires managers responsible for submissions globally. Close collaboration with pharmaceutical industry. Design of regulatory submission strategies for new products worldwide. Coordination of container closure systems (sterile syringes, non-sterile glass containers) registrations globally. In-depth knowledge on regulations for drug container submissions in US, Canada, China and EU (MDR).

- Cross-functional management & coordination of regulatory projects between R&D, business development and RA o submission strategies globally o Feasibility assessment for new product registrations or product amendments o Coordination of registrations globally - Profound regulatory knowledge about primary packaging registration globally (US FDA, MDR in Europe, HC, China NMPA) - US-FDA, HC and China Drug Master File writing and life cycle - authority contact for DMF deficiencies - eCTD (docuBridge)

Regulatory Affairs and Quality Support for Pharmaceutical Packaging - DMF handling in CTD for FDA and HC - deep knowledge about China DMF preparation due to new regulation of Nov 2017 - consultacy for Pharma companies regarding China DMF submissions - built a new document management system for statement, certificates and other regulatory documentation

I joined the Scientific Support team for EMEA to assist customers regarding questions about the entire Corning portfolio for pre- and after sales support, product selection and providing product information and troubleshooting. This supposes a strong technical background, in depth product knowledge and continous training as well as an excellent understanding of the process and responsiblities in the company. I provide product trainings and represent Corning at exhibitions.

Projekt: “Characterization of host-pathogen interactions between human and Chlamydia” Unité de biologie interactions cellulaires, Dr. Agathe Subtil

Projekt: “The Exocyst Complex in Dictyostelium discoideum: Localization and functional characterization”; Abteilung Biochemie, Doktorvater: Dr. Thierry Soldati

Genetik, Zellbiologie, Entwicklungsbiologie, Diplomarbeit in der Abteilung Genetik, Betreuer: Prof. Dr. Wolfgang Nellen Projekt: “Functional analysis of the Histone-3 Lysine-9 Methyltransferase SuvA in Dictyostelium discoideum”