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To conduct dossier assessment for product registration To develop and adopt necessary regulatory tools such as guidelines, SOPs, and official forms within the regulatory framework to standardize and improve the assessment procedures, To contribute to the product register updates with variations, new registrations, and deletions due to GMP failure and safety issues, To assess bioequivalence of generic pharmaceutical products compared to reference products by reviewing bioequivalence studies, To organize samples for and liaise with the Division of Quality Control Laboratory testing and analysis to facilitate product assessment and registration. To participate and conduct operational research, programmes, and projects within the Division. To demonstrate the ability to consistently provide quality services that meet customer and regulatory requirements within his/her division to meet Rwanda FDA quality objectives. To participate in organized training in Quality Management System. To do the assigned tasks (job) by fully implementing the QMS established requirements