Senior Consultant, Regulatory Affairs
Estelle earned her Pharm.D. degree from the University Claude Bernard of Pharmacy in Lyon, France (1997-2005). She also holds a Master’s Degree in Regulatory Affairs at the Institute of Pharmaceutical Industry in Lyon (I.P.I.L.), France (2004).
Her recent client activities include:
Estelle was nominated for the TOPRA Awards Support Category in 2020 by one of BlueReg’s clients for her outstanding work over a prolonged period.
Estelle has extensive expertise in global regulatory affairs including development and lifecycle management gained through a number of positions in the pharmaceutical industry over the past 13 years.
Prior to joining BlueReg, Estelle was Global Regulatory Affairs Project Manager responsible for the Immunotherapy therapy area) and then in another biologics company responsible for Neurology. Estelle led the development strategy of new products (new chemical entities, biologics, recombinants) and new indications in neurology and allergology (immunotherapy) worldwide (European Union (EU), United-States (US), Japan, Emerging markets). She has gained a significant expertise in clinical trials management from first-in-human study to phase III programs with a broad geographic coverage (incl. US, EU, Canada).
In the frame of these development activities, she led in particular pediatric plan submissions (EU and US), scientific advice meetings in EU (MHRA, PEI), managed an orphan drug designation application (US/EU) and led the submission of a new MA in Japan. In her past experience, Estelle also managed operational regulatory activities for Europe and Emerging Markets and regulatory pharmaceutical activities (Quality modules writing, file audit (CMC)).
These experiences enabled her to extend and strengthen her skills in pharmaceutical development (Quality modules writing, file audit (CMC) and international registration (national, European procedures (MRP/DCP), emerging markets) of drug products acquired during her previous industry roles.
Estelle joined BlueReg in 2016 as Senior Consultant, European Regulatory Affairs.