Senior Consultant, CMC Scientific Writing
- Pharmaceutical development
- CMC regulatory affairs
Master degree in « Gestion et Administration des entreprises », IAE – Nice University, France – 2010
Scientific degree in Analytical Chemisry, Nice University, France – 1988
Sébastien has significant experience in CMC regulatory affairs and pharmaceutical development, gained through 20 years of experience working within pharmaceutical industry on international projects.
He started his professional career in 1998 at Galderma R&D, where he gained hands-on experience in analytical sciences. As Highly qualified technician, he was in charge of analytical procedures development and validation, batch release and stability study analysis on semi-solids products intended for topical application.
He then moved to Gobal Regulatory Operation department of Galderma R&D, to a new position of Scientific Writer. He was in charge of writing multidisciplinary regulatory documents intended for clinical trial authorizations or marketing application dossiers (Europe, USA, Japan, geographical roll-out).
He was specialized in CMC sections (Module 3 of the CTD), due to his background and expertise in pharmaceutical development and analytical sciences.
After 20 years in pharmaceutical industry, Sébastien moved to consultancy and joined BlueReg Pharma Consult in May 2018.