Myriam GHOUMA

Regulatory and Pharmaceutical Affairs Advisor

Engineer in Industrial Biology
Master’s in Biomedical Engineering – Paris Descartes University & Arts et Métiers

Myriam is an industrial biology engineer specialized in the pharmaceutical industry and innovation. She holds a Master’s degree in Biomedical Engineering from Paris Descartes University and Arts et Métiers. She began her career in consulting for the pharmaceutical industry, working on an outsourced CMC platform exclusively dedicated to the Pierre Fabre group. This role gave her a solid foundation in post-marketing regulatory affairs through the management of a diverse product portfolio and coordination of cross-functional projects. To further develop her technical-regulatory expertise, Myriam joined the GSK Mayenne production site, where she contributed to MA dossier writing (Module 3), variations, renewals, registration strategies, and health authority responses.

Her professional path demonstrates a strong interest in regulatory affairs, complex project management, and the implementation of large-scale strategies. At Atessia, her skills are a valuable asset to the CMC team, particularly in bridging regulatory affairs with future registration projects.

Expertise

MA Holder

Regulations

MA Dossiers

Project Management

Registration

Enregistrement

AMM / Post-AMM