Вакансия № 18724430 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 28 сентября 2024 года.
Дата обновления вакансии № 18724430 на сайте Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 11 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 18724430 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
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Manage regulatory submissions and lifecycle maintenance activities according to company strategy and ensure registration deadlines are met;
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Ensure timely preparation and compilation of registration dossier in accordance with EU or relevant Health Authority standards and corporate requirements;
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Respond to Health Authorities’ queries and deficiencies in a timely manner;
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Track submission progress through efficient communication to relevant and Regulatory Service Providers (RSPs);
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Liaise with other departments to support the timely introduction of new products into markets;
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To track the submission status via official MoH web site to follow up on new submissions, variations, withdrawals and other items as and when required;
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Assisting QA manager Russia in communication with the laboratories and HA related to registered specifications and methods of analyses;
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Close cooperation and communication with other entities / stakeholders in order to obtain timely product approvals;
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Monitor planned approval timelines and if necessary, intervene in order to facilitate approval and minimise registration delays;
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Provide regulatory input to product lifecycle planning, including building of renewal plans and monitoring and assessing the risk related to “sunset clause” provision;
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Ensure that any regulatory changes communicated to the Pharmaceutical industry by regulatory authorities are communicate to the Head of RA;
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Assist with customer complaints handling to ensure they are dealt with efficiently and effectively and in accordance with the technical agreements;
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Assist QA manager Russia in recall/quality defect activities as required on behalf of the MA holder and notifications to HAs.