Менеджер по регистрации

Описание

A foreign company has an open position for a Registration Manager Responsibilities: Leading of registration projects in scope of responsibility. Building of registration strategies for projects/products registration activities. Routine communication with Competent Authorities at all steps of products registration process. Non-routine communication with Competent Authorities when regulation clarification is needed. Communication with third parties in frame of registration projects in scope of responsibility. Preparation of official letters to Customers upon requests from other departments. Review and assessment of regulatory documentation prepared by the global regulatory department for further submissions to local Regulatory Authorities. Dossier documents preparation, translation arrangement, registration dossiers compilation for new products submissions in accordance with yearly registration plan. Accomplishing and ensuring on-time submissions and approval of renewals and variations. On-time dossiers preparation and submission to harmonize with regulatory requirements of Eurasian Economic Union. Completion of different administrative tasks in accordance with the local requirements and internal procedures to ensure on-time dossiers submissions. Raising of potential risks, gaps in the assigned projects and building of mitigation plan. Delivering projects on time. Providing support for EAEU GMP inspections of manufacturing sites in terms of dossier-related information. Support other departments with RA information/communication. Proper maintenance of regulatory records in compliance with procedures. Ensuring regulatory compliance of printed packaging materials Reviewing and ensuring compliance of local promotional materials. Participating in assessment of deviations, change controls upon requests. Requirements: University degree English language - advanced written, fluent speaker Deep knowledge and understanding of local and EAEU legislation in area of circulation of medicines, feed additive, biocides and other products for veterinary use Experience of working in Regulatory Affairs either in local or international company Personal accountability and strong drive for execution Ability to set priorities and manage multiple tasks Strong interpersonal and communication skills