Mes compétences :
OTC
FDA regulatory affairs
GMP
EU regulatory affairs
Product Lifecycle Management
CMC drug development
Regulatory strategy
Clinical trials
Entreprises
Cenexi Services
- Chef de projet affaires réglementaires
2016 - maintenant
Coopération Pharmaceutique Française
- Chargée d'affaires réglementaires
2015 - 2015
Innothera
- Chargée des projets affaires pharmaceutiques
Arcueil2013 - 2014
Sanofi
- Regulatory site officer
Paris2012 - 2013CMC
Sanofi
- Global Regulatory Affairs - CHC intern
Paris2012 - 2012
Merck Sharp & Dohme Peru
- Regulatory Affairs intern
2010 - 2010• Drug regulatory compliance analysis.
• File development, submission and registration for MAA, tracking of new applications, renewals and variations, according to local legislation (Peru and Bolivia).
• Regulatory Affairs database management.
• Interpretation of queries raised by the local agency and preparation of the consolidated response documents.
• Working with diverse groups of individuals in a team environment: Communication with the US Headquarters, interaction with the marketing and sales department.
• Participation in the review of regulatory policies (impact of changing legislation) and/or guidelines.
2010 - 2010• Management of deviations.
• Data analysis (identification of trends, deviations, recurrences).
• Evaluation and validation of clean rooms.
