1. Pharm D. specialized in CMC Regulatory Affairs
And Pharmaceutical Formulation
JOB EXPERIENCES
Since Sept. 2015: CMC Regulatory Affairs Manager, F. Hoffmann-La Roche Ltd, Basel (Switzerland)
- Supporting global CMC regulatory teams to help write CMC sections of clinical (IND/CTA) applications.
- Participating in cross-functional CMC project teams to assemble CMC documentation for global
submissions.
- Leading review discussion.
- Supporting review of submissions.
Feb. 2012 – Aug. 2015: Regulatory Affairs Officer, CMC files, Les Laboratoires Servier ; Suresnes
(France)
- Writing/update of the Module 3 for European Union and worldwide countries.
- Writing answers to the Health Authorities questions for European Union and worldwide countries.
- Writing and submissions of variations and grouping variations for European Union and worldwide countries.
- Survey on DMF (Drug Master File) and CEP (Certificates of suitability to the monographs -of the European
Pharmacopoeia) regulations in worldwide countries.
- Updating and maintaining internal regulatory databases.
March 2011 – Aug. 2015: Intern in Galenic development, Technologie Servier, Orleans (France)
- Bibliographic search to find suitable excipients with the active ingredient.
- Development of new preclinical forms with technicians.
- Focus testing.
- Characterization of formulations and interpretation of results.
EDUCATION
2005 - 2011 Pharm. D School of Pharmacy (Bordeaux).
2010 - 2011 Master’s degree (Galenic Formulation) Institut Supérieur de Santé et des Bioproduits d’Angers.
LANGUAGES
French Mother tongue
English Fluent (Professional)
Spanish Basics
VARIOUS
Computer & software skills : MS office (Word, Excel, Power Point)
Sports : rugby
Hobbies: concerts, trips (Japan, Laos, UK, Spain…)
Vincent GUYOT
11, rue BERLIOZ
68330 Huningue
FRANCE
: +33 6 67 33 96 68
vincent.guyot.acepb@gma
il.com
30 years old, single