Regulatory Affairs Specialist
Hayat Pharmaceutical company
مجموع سنوات الخبرة :1 years, 1 أشهر
1- Establishment of monthly plan and to follow up accordingly with the priorities in parallel with pipeline .
2- Preparing Biowaives based on BCS classification as well as checking out clincal/bioequavalent/ studies.
3- Preparing and revising the technical file for registering and renewal( P-part and revising S-part) for (JFDA /SFDA/Sudan/Lebanon /Iraq /Kuwait/ Algeria).
4- Classification for food supplement product such as vitamin and mineral.
5- Answering deficiencies based on different pharmacopeias and Guidelines such as the (ICH, EMEA, …) and difference guidance's for each country .
6- Updated finished product specification and raw specification per the latest pharmacopeias.
7- Revising certificate of analysis for the finished and raw materials.
8- Formate the technical file to NeeS, CTD and e-CTD formats.
9- Preapare PMDDs (primary material design data sheet)