Regulatory Affairs
self Employed
مجموع سنوات الخبرة :10 years, 11 أشهر
Worked On Module 2.4 & 2.5 Clinical & Non Clinical Overview for registration pharmacist
Work on collecting data through questionnaires applied on pharmacists in community pharmacies for a study on probiotics, then analyze this data on SPSS.
CTD and e-CTD preparation and compilation.
keep a contact with other departments like Q.C and R&D to make sure i'm submitting the updated data and specs .
Mainly responsible on GCC countries and Yemen and also participating in other countries projects as needed.
responsible for all registration and re-reg. and variations in the countries i'm responsible for .
Analyze deficiency letters and reply to them within the timeline .
make sure im following the latest updated guidelines .
Medical representative
checking prescriptions to ensure that there are no errors and that they are appropriate and safe for the individual patient.
providing advice on the dosage of medicines and the most appropriate form of medication, for example, tablet, injection, ointment or inhaler.
ensuring medicines are stored appropriately and securely.