Regulatory affairs specialist
Sanofi
مجموع سنوات الخبرة :12 years, 3 أشهر
1) Update the package leaflet inserts of all pharmaceutical products of the company.
2) Revise promotional materials, prepare their files and submit them to MOH to grant the approval to market pharmaceutical products.
3) Update the pharmaceutical products’ files with the latest variations.
4) Registration of new pharmaceutical products introduced to the Egyptian market.
5) A member of the audit inspection team in the company.
1) Visit physicians on daily basis at their clinics at night or at the hospital in the morning to inform them of new clinical trials.
2) Organize round table discussion meetings for physicians on monthly basis to present new case studies and new international guidelines for treatment paradigm where I act as a presenter and a moderator of the session.
3) Track drug sales at an assigned territory as I have a monthly sales target of a certain drug to achieve.
4) Assigned to update physicians with new data and clinical trials related to hypertension drugs and track sales update with pharmacists at Arab Industry Organization and Eastern Company.
1) Visit physicians on daily basis at their clinics at night or at the hospital in the morning to inform them of new clinical trials.
2) Organize round table discussion meetings for physicians on monthly basis to present new case studies and new international guidelines for treatment paradigm where I act as a presenter and a moderator of the session.
3) Track drug sales at an assigned territory as I have a monthly sales target of a certain drug to achieve.
4) Assigned to update physicians with new data and clinical trials related to diabetes drugs and track sales update with pharmacists at Eastern Company.
5) Work every Saturday as part of an awareness team that informs patients about diabetes complications and how to take their medicine in the right way, at the right time using the right dosage. Also, measure blood glucose level of patients to make sure they are controlled and they are adhering to their treatment plan.
• Community pharmacist at El-Ezaby pharmacy, summer 2010.
• Medical representative trainee at Fresinius Kabi, summer 2009.
I have completed a diploma in total quality management at the American University in Cairo. The diploma has covered the following topics: A) Planning for top quality (Establish project, identify customers, define customer needs, develop product and process and establish process controls). B) Standards for quality and environmental management systems and Baldridge award (ISO 9001 and ISO 140001). C) The basic six sigma breakthrough improvement process. D) Statistical quality control (Fundamentals of statistics, fundamentals of probability, statistical inference, control charts for variables and for attributes and lot by lot acceptance sampling). E) Project management (Overview, project planning, initiation, execution and closure and PERT) F) Managing the quality functions (Basic quality concepts, process management, organization for quality, supply chain management, operations-manufacturing sector and service sector, inspection, test and measurement, marketing and customer service, quality information system, companywide quality assessment, strategic quality management and developing a quality culture).
• Faculty of Pharmacy, University of Cairo (overall grade: good), 2011.
• Manor House School (American Diploma section), 2005.
• Ramses College for Girls, primary & preparatory school, 2003.