от компании (организации): ANCOR Consumer Goods в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Фармацевт"
с заработной платой: по договоренности
Вакансия № 9460163 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Среда, 14 августа 2024 года.
Дата обновления вакансии № 9460163 на сайте Работа в Москве и Московской области (МО, Подмосковье): Среда, 25 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 9460163 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
1–3 года
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Regulatory Affairs Specialist
In large international pharmaceutical company open position Regulatory Affairs Specialist.
Main responsibilities:
- To review and assess regulatory documentation prepared by global regulatory department for further submissions to local Regulatory Authorities;
- Own interactions with Competent Authorities at all steps of product registration process , prepare dossier documents, arrange translation, complete registration dossiers for new products submissions in accordance with yearly registration plan , to ensure in-time receiving of approval documents;
- To accomplish and ensure in-time submissions and approval of renewals and variations;
- To arrange payment of local regulatory fees, to ensure import permits obtaining for registrations samples delivery;
- To identify potential risks and gaps in the assigned projects and propose solutions to mitigate those;
- Accountable for providing the most accurate and up-dated information about regulatory requirements in geography of responsibility in respond to any intra-company internal request;
- Deliver projects in time, whilst ensuring communication of status and requirements across multiple business functions, organize and hold regular calls and F2F meetings with involved function areas;
- Ensure regulatory compliance of printed packaging materials;
- Prepare responses to official requests received from the Local Regulatory authorities;
- To review and ensure compliance of local promotional materials;
- Understand and act according to regulatory compliance and local policies, track and follow-up on any changes in regulatory requirements of CIS/RU;
- Ensure compliance with procedures and systems necessary to maintain proper regulatory records;
- Support other departments with RA information/communication.
Requirements:
- University degree in pharmaceutical or medical sciences, with veterinary study preferred;
- English language - Intermediate (written/speaker);
- Good knowledge and understanding of local legislation in regulatory sphere;
- Experience of working in Regulatory Affairs in local either international company.
Откликнуться на эту вакансию: Regulatory Affairs Specialist
Предыдущая вакансия:
Вакансия № 9460158 на должность Бизнес-ассистент от компании Selecty в городе (населенном пункте) Москва