RUEIL MALMAISON
Senior regulatory manager with more than 30 years of experience in the pharmaceutical industry. High expertise in creation and maintenance of core and key regional labeling, preparation and review of global dossier summary documents, development, coordination and implementation of response to Health Authorities requests mainly in the pharmacokinetics field, interpretation and implementation of key regional labeling guidelines (EU & US), preparation and review of Briefing books, IND, CTD, NDA. Proven scientist with publications in international journals (upon request).
Mes compétences :
Pharmacokinetics
Regulatory Affairs
Pas de contact professionnel