Marie Regnat Sauvageon

Marie Regnat Sauvageon

Chief Pharmaceutical Officer

Key Knowledge Areas

  • Quality Management Systems
  • CMC (Chemistry Manufacturing and Controls)
  • Product Quality Review
  • Project Management

Contact

Education

 

Marie is a pharmacist and completed her Pharmaceutical education at the University of Paris XI (2013). She also obtained a Master Degree in Regulatory Affairs Health Industry at the University of Paris XI and completed her residency in Paris Hospitals (2013).

 

About Marie

 

Marie is Chief Pharmaceutical Officer of PharmaBlue within BlueReg.  

 

PharmaBlue partners with Global Healthcare Companies developing innovative medicinal products for unmet medical need in rare or serious diseases and offers a full platform to allow early commercialization of these products in France.

 

Background/Past experience

 

From 2008, Marie developed her skills in Regulatory Affairs then in Quality Assurance during her 4 years of Internship in Pharmacy. After two years within hospitals (Biochemistry service, Toxicology and Pharmacy), Marie joins the European Pharmaceutical Affairs Department of the laboratory NOVARTIS Pharma, within which she acquires skills in the preparation and the follow-up of the submissions of clinical variations and amendments of clinical trials. Marie joins then laboratories SERVIER, within the Japanese Pharmaceutical Affairs Department of the International and pre-recording Division where she makes her PhD thesis on the Japanese regulations.

 

Then, Marie joins the Quality Department of the General Agency of Equipments and Products of Health (AGEPS) where she takes care of the constitution of Product Qquality Review. This experience will be followed by a half-year within the Inspection Division, of the French National Agency for Medicines and Health Products Safety (ANSM). Within the framework of her job, she has the responsibility of activities in connection with the simplification of the processes of the department and the opportunity to develop her skills in audit with the participation in several on-site inspections carried out by the Agency.

 

At the end of her internship, Marie begins her career in 2013 within the laboratory ROCHE as Regulatory Affairs – Pharmaceutical Quality Assurance Pharmacist. During 2 years, she consolidates her practical experience in the activities of Quality Assurance of the affiliate in France. She participates in the set of the activities of Quality Assurance among which the management of the complaints and the quality alerts, the constitution of Annual Product Quality Review, the management of breaks beyond the cold chain, the update of printed packaging materials, the writing and the update of the procedures, the review, the preparation and the follow-up of the submissions and the deposits of pharmaceutical variations.

 

Marie joins in 2015 the laboratory NOVARTIS Animal Health which became ELANCO, Lilly French animal health affiliate, as Quality Manager of the affiliate in France. As such, she handles in association with the Qualified Person and the Regulatory Affairs Director, all the activities of Quality Assurance of both Novartis and Elanco sites. This year of transition further to a repurchase allowed Marie to acquire skills in the management and the harmonization of the Quality Management Systems of both entities. 

 

Through these experiences, Marie has developed her skills in terms of project management, team work and information share.

In January 2017, Marie moved to consultancy and joined BlueReg.