Regulatory and Pharmaceutical Affairs Advisor
Doctor of Pharmacy (Lille)
DU Quality auditor in the pharmaceutical industry (Paris Descartes)
MSc Modern Methods of Drug Discovery and Development (Lille)
MSc Regulation of medicines in the European Union (Lille)
Stéphanie has worked for more than 8 years in different types of pharmaceutical companies: Biogaran, Hospira, Pfizer and also within AGEPS.
Indeed, Stéphanie started her career in a generic company & parent company Biogaran as a Regulatory Affairs Project Manager. Her main missions were related to advertising control, DMOS and regulatory monitoring. She was also involved in maintaining the portfolio of OTC medicines and monitoring products undergoing benefit/risk re-evaluation.
She then joined the French subsidiary of Hospira, a human-sized structure, allowing her to perform various and varied functions in a very autonomous way around activities related to the registration of new hospital drugs and their follow-up, to the medical and pharmaceutical information of the exploitant as well as to the control of promotional elements and training. She also tooks part in vigilances activities, in the processing of quality complaints and in the monitoring of temperature probes, both in terms of management and in the drafting of procedures and other Quality documents.
When Hospira was acquired by Pfizer, Stephanie had the opportunity to coordinate the transfer of marketing authorizations. Her years at Pfizer allowed her to build up expertise in registration and advertising control. She also had the opportunity to develop her skills in quality management (APQR, audits, quality system management, administrative batch release, etc.).
This experience in quality of exploitant encouraged her to discover and better understand the other side of quality: the quality on manufacturing site. This is why she did an internship at the AGEPS production plant to learn more about audits, PQR and CAPA management.
After these various professional experiences, both technical and human, Stéphanie finally decided to join the consulting firm Atessia to benefit from her various skills acquired with manufacturers.