I am passionate about pharmaceutics, pharmaceutical manufacturing sciences, product design, product evaluation, pharmaceutical regulatory affairs and pharmaceutical statistics. In my professional career and my master’s thesis, I studied and developed many products including semi-solid, liquid and solid dosage forms (IR, SR and targeted DS). On the other hand, I participated in and supervised the various regulatory activates in Egypt and GCC countries including new submissions, variations and renewals. I dealt with numerous types of products including brands, second brands and generic products. I communicated with multiple external stakeholders including API manufacturers, agents and partners in Japan, Europe, US, India, China and GCC countries beside the internal communication with R&D, QC, QA , BD and marketing departments. My extensive experience in the industry helped me studying the submissions thoroughly, especially the Quality module, which contributed to better submission efficiency and integrity. Also, it allowed me to handle and address the authorities’ inquiries professionally. I managed to implement internal and external measures to expedite the regulatory processes. I’ve always been keen to monitor the global regulatory environment to study the opportunities and threats with respect to my company. Reporting the global changes to business development and technical teams resulted in achieving success stories and prevented potential failures.