Celine MAIRE-MODERNE

Full time Master Program of Management : First Price in SMBG rank for the speciality : Organisational Management

I was in charge of overseeing the analytical development of commercial products. This purpose was to ensure that Marketing Authorisation Files were updated on time and that the required quality level was achieved, both in accordance with the authorities requirements and the imput other departments, including Formulation Development, Quality Assurance, Regulatory Affairs. Part of my responsibilities consisted in ensuring good communication with these departments and also dealing with health authorities.

My role was to implement plans for up-dating the Marketing Authorisation Files in accordance with the authorities requirements. The purpose consisted of defining which improvements were required and which of them were high priority. The others aims on the role were to : o Validate the analytical Methods, o Establish the stress testing, o Identify synthesis and/or degradation impurities, o Write the SOP (Standard Operating Procedures) o Plan and manage « on going » stability studies