Estelle Decarli

Estelle Decarli

Senior Consultant, Regulatory Affairs

Key Knowledge Areas:

  • Global Regulatory Affairs
  • Regulatory Strategy
  • Product Development
  • Lifecycle Management

Contact

Education

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).

 

About Estelle

Her recent client activities include:

 

  • Managing activities related to Clinical Trials Applications (CTA) and subsequent maintenance: coordination and review of core CTA documentation (protocol, Investigator’s Brochure, Investigational Medicinal Product Dossier (IMPD)/Investigational New Drug (IND) and preparation of the applications
  • Assisting clients in the definition and implementation of global regulatory strategies for development projects (early stage development projects and new indications development for approved medicines)
  • Managing the life cycle management (variations, renewals, PSUR…) of medicinal products authorized in the EU (Oncology) and acting as Global Regulatory Affairs representative for the client
  • Acting as project manager to ensure oversight of a platform of consultants dedicated to outsourced regulatory activities by clients

 

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.

Background/Past experience

 

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.

 

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