Hadeer Hossam El-Gammal

Regulatory Affairs Specialist

• Job Details:Responsible for the registration and re-registration of pharmaceutical products, dietary supplements, and cosmetics with the Egyptian Drug Authority (EDA). Prepare and submit various required requests for new product registration, such as box inquiries, naming lists, and pricing files. Prepare and submit the required files for the registration process, such as stability studies, bioequivalence studies, inserts, layouts, nodcar files, and pricing files (including new pricing files, price increase, renewal and re-evaluation, renewal only, appeals, and pricing update requests). Prepare the priority requests for the company's registered, marketed or non-marketed products submitted in the EDA pricing wave. Submit variation requests and respond to any follow-up comments within the specified timeframe. Follow up on all files submitted to the EDA until approval is granted. Follow up on updates to regulations and announcements published by the EDA on its official site, ensuring compliance with the latest requirements. Prepare daily and annual reports to ensure that work follow-ups are conducted efficiently and accurately.