Regulatory affairs

I worked for over 10 years as RA specialist at different companies located in Bucharest (Roche, Sanofi, Zentiva, etc); I am attending to the DRA Master studies at Uni of Bonn; I am interested in MRP/CDP, CMC, Module 1&3 CTD, Variations, Labelling

• Chemie
• Pharmaforschung

- Management of RA submissions under MRP/DCP procedure based on clever strategies;
- Preparation, review and submission of variations in Europe;
- Compilation of full submission dossier for generics with focus on Modules 1 & 3 of CTD
- Preparation and review of CMC-data for Module 2.3 (Quality Overall Summary) and Module 3 (Quality)
- Ensure labelling updates;
-CESP submissions;
- e-CTD Manager compilation;
- Data base updating;
- Update core texts SmPCs/PL/Labelling for EU registration procedures MRP/DCP/CP in English for variations and renewals;
- Coordinate and implement translations for EU registration procedures MRP/DCP/CP
- Interact with relevant authorities as needed
- Respond to questions raised by authorities as needed