Менеджер по регистрации (декрет)
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 registratio 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