от компании (организации): ЗАО Рош-Москва в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 14036441 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Среда, 23 октября 2024 года.
Дата обновления вакансии № 14036441 на сайте Работа в Москве и Московской области (МО, Подмосковье): Четверг, 14 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 14036441 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: Regulatory Policy Specialist
Role is 60% Regulatory Policy (incl. approx. 30% for PHC-related activities), 20% Regulatory intelligence, 20% registration-related activities (dossier submission preparation incl. all functions, etc.).
- Lead regulatory policy and regulatory PHC activities and develop clear, evidence-based and compelling positions that enable the delivery of Roche's Policy and PHC strategy.
- Have command of all Roche regulatory policy and regulatory PHC activities including oversight on requirements, legislations and regulatory environment. Represent Roche regulatory policy and PHC views during external stakeholder engagement.
- Create and execute regulatory policy projects (including PHC projects) to shape regulatory environment/regulations in line with company position and in close collaboration with Global Regulatory Policy teams
- Participate in industry association on regulatory policy, regulations, PHC activities, taking regulatory convergence into consideration and provide the necessary briefing in department about the works conducted with the association
- Lead planning and organization of educational workshops with relevant local agency to enhance capacity building
- Contribute to global regulatory strategies, considering local regulation and business needs
- Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards, follow developments and changes in the local & global regulatory/GMP policies and take actions assessing the effects of the developments on business
- Participation and providing input in PHC Affiliate and HQ cross-functional projects
- Participation in commentingng of all the establishing governmental regulatory documents gathering and consolidating of all the opinion of affiliate regulatory experts
Requirements:
- Work experience as regulatory manager/regulatory specialist not less than 2 years in the international company;
- Deep knowledge of legislation in the sphere of medicine/pharmaceutics/drug registration;
- Fluent English;
- Medical/pharmaceutical/chemical/biological +legal education as an advantage;
- Excellent communication skills
Откликнуться на эту вакансию: Regulatory Policy Specialist
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