Менеджер по регистрации

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