Marie-Caroline Leclere

Director Regulatory Affairs

BlueReg Group Marie-Caroline Leclere

Marie-Caroline Leclere

Director Regulatory Affairs

Contacter
Marie Caroline Leclere Associate Director, Regulatory Affairs at BlueReg Group

Education

Marie-Caroline earned her Pharm.D. degree from the University of Pharmacy in Marseille, France.

 

About Marie-Caroline

Marie-Caroline has a broad experience in regulatory affairs including development and life cycle management activities for medicines gained through a number of positions in the pharmaceutical industry over the past 20 years.

Marie-Caroline has been involved in various regulatory projects assisting start-up to international companies. Her recent client work includes:

 

  • Development activities: management of operational and strategic activities for development of products: elaboration of registration strategies, leading of scientific advices with the Health Authorities, CTAs (initial submission and follow-up), participation to cross-functional meetings
  • Scientific writing activities including: Preparation of Briefing packages for scientific advices (EU, US), answer to questions from Health Authorities
  • Registration activities: Marie-Caroline led new MAA applications in EU procedures (MRP, DCP and centralized procedures), advices on registration strategies, she acted as Global Regulatory Affairs representative and provided required regulatory support to company’s functions.

Background / past experience

 

Prior to joining Bluereg, Marie-Caroline worked for several companies in Paris and in the South of France. During her past positions, Marie-Caroline has been covering a wide range of regulatory activities for registration of medicines in EU and outside EU. She worked on various development projects requiring a regulatory strategy input such as scientific advices (EMA, EU National Agencies, USA, Australia …), Paediatric Investigational Plan, Orphan Drug Designation, Clinical Trial Applications, and managed registration procedures (Centralised, MRP/DCP and national procedures).

 

She has also covered other activities including registration of drug products in Asian, Maghreb and Eastern Europe countries, lifecycle activities (renewal, variations ….) of approved drug products, as well as contribution to due diligences.