от компании (организации): АО Про.Мед.ЦС Маркетинг в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Фармацевт"
с заработной платой: по договоренности
Вакансия № 22952188 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Пятница, 13 сентября 2024 года.
Дата обновления вакансии № 22952188 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 10 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 22952188 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
3–6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Registration specialist
The main responsibilities of an Employee are:
- Ensuring of timely submissions and approvals of new drug products registration (marketing authorizations obtaining), registration period prolongation for registered products, bringing the registration dossier into line with EAEU requirements, and variations to the approved registration dossiers in accordance with the registration schedule/regulatory requirements (EAEU and RF legislation);
- Submission preparation: check-lists preparation, relevant payments implementing, documents for dossier (checking, correction, confirmation), ensuring of timely documents translation and notarization, projects of registration documents (PIL, SmPC, ND, mock-ups) preparation and confirmation, dossier compilation and printing;
- Applying a company local regulations and guidelines to standard submissions to ensure compliance of all regulatory actions with corporate standards/guidelines;
- Dossier submission, registration process maintenance, tracking all steps of evaluation process of registration dossier;
- MoH/FGBU request evaluation, ensure of translation, request of the documents and information for the answer from HQ;
- Answer preparation: documents for answer (check, correction, confirmation), projects of registration documents (PIL, SmPC, ND, mock-ups) correction and confirmation, answer compilation, submission;
- Obtaining of MoH permission for samples importation: documents preparation, dossier compilation, submission;
- Preparation for Pharmaceutical examination: ordering samples, RS and materials for pharmaceutical expertise within appropriate timelines; coordination with FGBU, documents compilation, submission to FGBU;
- Communication/negotiation with expert organizations and health authorities engaged in registration and evaluation of pharmaceutical products;
- Coordination with HQ on all steps of evaluation process of registration dossier;
- Database maintenance: archiving of the documents, registration dossiers and approved documents in a paper and electronic versions;
- Check of the correctness of information in the State Register of Registered Medicinal Products;
- Ensuring of timely submissions and approvals of Food supplements registration in accordance with the registration schedule/regulatory requirements (EAEU legislation);
- Check of packaging material and package inserts providing, necessary communication with HQ labeling specialists; packaging materials library maintenance;
- Ensuring of timely submissions and getting of CPP and Free-Sale certificates;
The general requirements of an Employee are:
- Higher pharmaceutical or chemical education;
- Experience in drug registration not less than 5 years;
- English - Intermediate level;
Откликнуться на эту вакансию: Registration specialist
Предыдущая вакансия:
Вакансия № 22952182 на должность Заведующий аптекой от компании Планета здоровья в городе (населенном пункте) Химки