Job Description
-Food supplement, special food for medical purposes & Drug registration applications in a timely manner
-Create and manage effective communication and close collaboration with MOH
-Prepare the DMF/PMF of new pharmaceutical products according to international guidelines
-Develop and register the new formula and product in the market
-Keeping up-to-date with the latest news in MOH, syndicates and pharmaceutical industry.
-Preparing and completing Regulatory documentation
-Familiar with IRC, TTAC website, registration of supplements and APIs, Working standard, medicines & getting IRC in MOH.
-Establish and maintain a system for tracking changes in documents submitted to regulatory authorities or CEO.
-Support in collecting and coordinate information and prepare regulatory documentation for submission to regulatory affairs (medicines and special Food supplement).
-Capable of traveling and site visits
-Submissions to the MOH, product registration, consumer information and all regulatory
-Activiti Team working in preparing the required documentation for submitting the pharmaceutical dossier into the ministry of health includes CTDs, SOPs, Reports
-Managing and conducting pharmacovigilance activities
-Price request submission to MOH according to MOH rules for price correction
-Maintenance of history of pricing changes
-Getting quota and price approval for first shipment of new product
-Develops and executes strategies related to achieve organizational goals aligned with MOH meet objectives
