Education: University degree in Pharmacy or Life scienceLanguages: Ukrainian - fluent; Upper-intermediate English as a business languageExperience: 3 years experience in Drug Regulatory AffairsCore knowledge, competencies & skills:Good knowledge and full understanding of pharmaceutical regulation, approval procedures, GMP certificates recognition requirementsGood oral and written communication skillsEffective time management skillsExperience in project managementWorks effectively with IT solutions, including electronic team workspaces and internal databasesPersonal Characteristics: Accountability, initiative, stress management, persistence, quick learning, result orientation, ability to work on one's own.Key Responsibilities:Supports GMP certificates recognition procedure (e.g. inquire the dossier from the site, check the dossier materials, answer to inquiry from the expert, negotiate with the site, track and communicate approval status)New submissions and maintenance of assigned procedures (e.g. variations, safety updates, renewals): coordinate, prepare and assure timely submission and approvals of dossiers for assigned registration procedures; track and communicate approval status perform tracking of deadlines, events and KPIsDevelopment of normative documents, instructions for use and artworks of drug products and following approval in relevant systemsDatabases maintaining with up-to-date informationObserve strictly all applicable internal and external regulations, acts and procedures.Comply with the GxP quality requirements applicable to his/her area of responsibility
