Senior Consultant, Regulatory Affairs
“Brings expertise in global regulatory strategies to support development and approval of new medicines or new indications as well as in life-cycle management (LCM) of approved drug products”
Estelle Decarli joined Bluereg Europe S.A.S. in 2016 as Senior Consultant, European Regulatory Affairs. Her recent client activities include:
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.
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)).
Estelle earned her Pharm.D. degree from the University Claude Bernard of Pharmacy in Lyon, France. She also holds a Master’s Degree in Regulatory Affairs at the Institute of Pharmaceutical Industry in Lyon (I.P.I.L.), France. She is based in Lyon (France).