Marie-Caroline Leclere

Marie-Caroline Leclere

Associate Director, Regulatory Affairs


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.


About Marie-Caroline

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


Background / past experience

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


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.

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