Вакансия № 20565416 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Пятница, 26 июля 2024 года.
Дата обновления вакансии № 20565416 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 22 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 20565416 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
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Develop, implement and maintain compliant, harmonised, best practice market clearance / registration processes
- Provide maturity and significant RA experience and expertise to the EMEA regulatory team to accelerate market access
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Ensure timely market access and regulatory compliance and build collaborative relationships with Russian regulatory bodies
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Leads the execution and delivery of the registration plan and reviews product documentation in accordance with local regulatory requirements
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File, maintain and organise local registration submissions and maintain regulatory flags in local ERP system
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Primary contact with Russian Competent Authority on market clearance activities, ensuring ongoing market access in line with business strategy
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Supports the execution of submission strategies and registration planning in collaboration with RA leadership
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Reviews product change notifications issued by international manufacturing sites, evaluates re-notification requirements and communicates to EMEA regulatory team
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Maintain active participation in product lifecycle management planning and associated regulatory execution
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Build, implement and maintain effective local product registration processes
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Analyse and monitor registration activity for all franchises on a periodic basis to ensure performance is in line with objectives and communicate performance to RA leadership
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Provide regulatory guidance and training to EMEA RAQA colleagues, new starters and Design Divisions as a subject matter expert on Russian regulations
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Monitor regulatory changes across and escalate to RA leadership as necessary
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Support the training of international Design Divisions in understanding registration requirements and design inputs for new product development
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Provide support to the local Russian RAQA team and EMEA Regulatory team on various activities as appropriate
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Support Corporate / International projects as required