от компании (организации): Sanofi в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Лекарственные препараты"
с заработной платой: по договоренности
Вакансия № 20862633 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Вторник, 20 августа 2024 года.
Дата обновления вакансии № 20862633 на сайте Работа в Москве и Московской области (МО, Подмосковье): Вторник, 24 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 20862633 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 Associate (Специалист по регистрации)
- POSITION: Regulatory Associate
- REPORTS TO: Regulatory Affairs Manager (global)
- REGION: Eurasia
SEND YOUR CV FOR THIS POSITION IN ENGLISH.
WHAT YOU WILL DO
- According to the local regulatory requirements and planning, assess, coordinate, and contribute to the elaboration of ready CMC package for International countries in line with regulatory CMC risk assessment defined.
- Assist the development of optimal regulatory strategies and its execution for post approval CMC dossier evaluation to drive early submission and approvals in accordance with agreed business priorities.
- Responsible to assess the needed regulatory alignment and ensure the completion of the Regulatory strategy document by all the counterparts.
- Support the CMC dossier elaboration and dispatch for products in scope, evaluation, and dispatch to the COE, ensuring compliance with local regulations and accomplishing timing needs.
- Assess the needed regulatory alignment and ensure the completion of the Regulatory strategy document by all the counterparts.
- Technical check according to the legislation of the consistency of the CMC dossier prepared and if needed, follow-up with the Regulatory Site Officer (RSO) within industrial affairs.
- Ensure the quality of CMC files sent, avoiding, or decreasing, the number of observations of the from Health Authority, in order to avoid delay in the processing times.
- Order the non-CMC related documents linked to CMC package and ensure coordination of the preparation of specific CMC where relevant.
- Provide CMC information for samples ordering (finished product, reagents, API, SRA/SRI) if relevant.
- Give accurate and timely information to maintain regulatory data base updated.
- Develop and maintain excellent relationships with GRA platforms and affiliates to ensure optimal stakeholder management and affiliate support.
- Monitor regulatory environment to identify potential future changes and ensure impact to business is communicated to relevant local and GRA contacts.
- Develop and update knowledge of the CMC legislation of International countries.
- Foster an environment/culture of learning and sharing of best practice within the team.
WHAT IT TAKES TO BE SUCCESSFUL IN THIS ROLE
- Minimum 3 – 4 years of proven experiences in Regulatory Affairs, Quality Assurance in international or local regulatory affairs.
- Project management experience in the pharmaceutical industry or in a regulatory environment.
- Knowledge in regulatory requirements and Good Manufacturing practices of the cluster.
- Fluent English is necessary.
This publication is hosted on behalf of Sanofi group of companies in Eurasia. Employment offer for the positions listed in this e-mail may be done by one of the companies of the group (including but not limited to Sanofi legal entities in Russia, Belarus or Central Asia) depending on availability of the relevant positions in the staff structure and their geographical location
Откликнуться на эту вакансию: Regulatory Associate (Специалист по регистрации)
Предыдущая вакансия:
Вакансия № 20862632 на должность Комплектатор Дизайнер от компании ИП Гайниева Анна Анатольевна в городе (населенном пункте) Москва