Drug regulatory affairs Consultant in the area of clinical trials, Bioequivalence studies, Biosimilars, and cGMP with over 23 years of working experience in the academic, research, pharmaceutical industry & Drug regulatory affairs fields. A demonstrated history of working in the pharmaceuticals industry in Europe & GCC region. a Pharmacy study & a Ph.D. in Pharmacy focused on Pharmaceutical Industry from Christian Albrecht University Kiel, CAU Zu Kiel, Germany.
Outstanding Teaching Experiences in the following science fields: Clinical Pharmacy, Pharmaceuticals, Medicinal Chemistry, drug discovery, and Pharmaceutical Biotechnology.
A strong track record of achievements in my current position as a Drug Affair Consultant. My day-to-day tasks include, among others:
– Evaluation of more than 1100 GCC & Local clinical, Bioequivalence & Biowaiver (M5) studies for NDA & ANDA drug products.
– Evaluation of biotechnology & biosimilar products, including Covid-19 Vaccines, Monoclonal AB & Antiviral drugs.
– Evaluation of all SUPAC Variations types.
– Updating Local & GCC Guidelines as a member of the cGMP & Bioequivalence committees.
– Staff Training in the field of cGMP, GLP, Bioanalytical & clinical, and Bioequivalence studies.
– Updating presentations regarding the international pharma Industry Guidelines.
– Staff Training in the field of cGMP, GLP, Bioanalytical & clinical, and Bioequivalence studies.
– Updating presentations regarding the international pharma Industry Guidelines.
– Updating presentations regarding Covid-19 vaccines & treatment possibilities during the Covid-19 Pandemic time.