от компании (организации): ООО Аксесс в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Регистратура"
с заработной платой: по договоренности
Вакансия № 10391707 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 3 августа 2024 года.
Дата обновления вакансии № 10391707 на сайте Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 23 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 10391707 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
более 6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Head of Regulatory Affairs
Responsibilities:
Ordering all necessary documents, standards and samples for new registrations, renewals, variations of medical products, medical devices and food supplements in Russia;
Preparation of registration documents (including ND, PIL, packaging) for submission to Russian Health Authorities according to local regulatory requirements;
Coordination work of group and responsible for results of all team;
Ensure that the interfaces between Regulatory and other departments are managed optimally;
Communication with Global RA and Pharmacovigilance; work coordination with Marketing and Logistics Departments on daily base;
Submission of new registrations, renewals, variations of medical products, medical devices and food supplements in Russia and support during full procedure;
Submission and support of price registration;
Support in case of GMP inspection;
Preparation of regulatory reports on monthly base;
Responsible for the budget of the Regulatory function;
Engage in cross functional team activities from initial stages of product planning through till securing government approvals;
Ensure the Company complies with current Local Health Authority regulations in Russia and Division Guidelines for RA;
Notify senior management of any notifications by Health Authorities or Regulatory Body for inspections, visits, permit renewals or licenses;
Proactively engage with regulators and health officials and maintain a positive relationship.
Candidate`s profile:
5+ years’ experience in local regulatory support in Russia;
Successful track of records in Russian GMP inspections and local clinical trials;
Good international and cross-functional communication skills;
Experience in Regulatory Affairs / medical devices registration, dossier update and registration update processes;
Good knowledge of the current regulation in Russia and upcoming EEU regulation;
Ensuring submission of the following reports for Competent Authorities when applicable: Aggregate Reports (e.g. Periodic Safety Update Reports (PSURs), Addendum to the Clinical overview (ACO), Risk management plan (RMP);
Goal oriented, responsible, dedicated;
Excellent communication skills, leader skills;
Good in listening, good problem-solving and influential skills;
Upper intermediate or intermediate level English;
Higher education (educational background in pharma or bio-engineering or chemistry).
Откликнуться на эту вакансию: Head of Regulatory Affairs
Предыдущая вакансия:
Вакансия № 10391686 на должность Уборщик жилых помещений (клинер) от компании Aclean в городе (населенном пункте) Москва