Estelle BRAULT

Senior Regulatory And Pharmaceutical Affairs Advisor

Doctor of Science
PhD in Human Genetics

Estelle worked for five years in a regulatory affairs consulting firm specializing in self-medication and herbal medicines at European level. As a Regulatory Affairs Consultant, she was involved in a variety of activities: developing regulatory registration strategies, managing national or European procedures in direct contact with health authorities, drafting MA files, and maintaining MA files (gap analysis, CMC variations, reformatting Module 3 to CTD format, etc.).

She then joined Galderma R&D as a Science Editor for more than two years. She was responsible for preparing clinical trial applications: drafting and coordinating with pharmaceutical, non-clinical and clinical experts for submission to health authorities in Europe. She also oversaw responses to questions from the authorities on MA applications (Module 3).

She later worked as Regulatory Affairs Manager at Virbac veterinary pharmaceutical company for two years. She was responsible for maintaining the MAs of veterinary medicines registered in Europe: planning and coordinating regulatory actions (renewals and variations) and managing procedures in direct contact with European authorities.

She subsequently turned to freelance consulting with the position of Scientific, Medical and Regulatory Editor.

Estelle joined ATESSIA in 2019 to bring her many skills to our clients and support our development at European level.

Expertise

Regulation

Medical

Scientific

Registration

MA / Post-MA