Sophie Azzaro

Sophie Azzaro

Consultant, Regulatory Affairs

Key Knowledge Areas:

  • Promotional Material Review (Drugs and Medical Devices)
  • Market Authorisation – Registration
  • Exportation
  • ATU

Contacter

Education

DEA of “Synthèse et Modélisation de molécules Bioactives” – Aix-Marseille (1998)

Master 2 of “Biologie et Pharmacologie du Vieillissement” – Paris V (1999)

 

About Sophie

Sophie has a broad experience in Regulatory Affairs and Quality Assurance gained through a number of positions in the pharmaceutical industry.

 

Sophie has been involved in various regulatory projects assisting start-ups to international companies as regulatory affairs consultant.

Background/Past experience

Sophie started her career in 2001 in Laboratoires Genévrier as a Clinical Research Associate CRA in the clinical research department. She was in charge of the initiation visits and monitoring of clinical trials of phase III of rheumatology, dermatology and gynaecology products in France and Belgium.

 

She held the position of senior CRA and in 2010, thanks to her expertise and her good relationship qualities she was promoted CRA manager. She managed CRA teams, coordinated training and team leadership activities.

 

In 2012, she held the position of medical writer and was in charge of writing application submissions for Transparency Committee and Pricing, scientific publications, clinical study reports for studies she monitored.

 

In 2014, she joined the regulatory affairs department as regulatory affairs officer and worked on the drafting of CE marking dossiers and the risk assessment of medical devices. She collaborated with the marketing department with regards to the regulatory control of promotional material.

 

In 2015, after an experience of 14 years in Pharmaceutical industry, Sophie oriented her career towards consultancy by joining BlueReg as Regulatory Affairs Associate.