Corinne Schmitz

Corinne Schmitz

Founder and CEO, BlueReg Group

Key Knowledge Areas:

  • Regulatory Strategy, Project & Team Management
  • Regulatory Affairs (EU & US) including Development, new registrations and life cycle management
  • FDA and European Regulatory Agency interactions
  • ATMP & Early Access Programmes

Contact

Education

 

Corinne is a Pharm.D. from the University of Tours, France. She has completed numerous leadership training programmes including a Pharmaceutical Healthcare MBA from Management Centre Europe, Brussels.

 

 

About Corinne

 

Corinne founded BlueReg in 2011 and since then, as CEO, has led the company to success with consistent year-on-year growth. BlueReg today employs more than 70 highly experienced consultants committed to providing high quality services.

 

Corinne has expertise in a broad range of regulatory activities including development and registration strategy and the full spectrum of regulatory agency interactions both pre- and post-authorisation.

Corinne has substantial experience in this area having held different positions in the pharmaceutical industry during 25 years, prior to setting up BlueReg.

Background/Past experience

 

Previously, Corinne led the European and international regulatory affairs at Allergan. 

In addition to overseeing a group of more than 20 regulatory affairs professionals and their associated activities, Corinne provided regulatory strategy to global development projects and managed successfully a comprehensive array of regulatory agency submissions for new drugs or new indications.

 

Prior to this, Corinne held management positions at several pharmaceutical companies including Roche and GSK. During this time, in addition to being involved in the registration of a wide range of new drugs, she gained experience in life cycle management (including regulatory compliance for promotional materials).

 

Corinne is a member of and contributes to industry groups such as AFAR (France), TOPRA (EU) and RAPS (US). She is also a member of the Drug Information Association and member of the French « Académie nationale de Pharmacie ». She was elected member of the « Conseil de l’Ordre des Pharmaciens » in France from 2015 to 2019.

In addition, Corinne was the 2017 Women Equity prizewinner (Palmares – Women entrepreneur – France South-East).