от компании (организации): RB в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 20757270 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Четверг, 25 июля 2024 года.
Дата обновления вакансии № 20757270 на сайте Работа в Москве и Московской области (МО, Подмосковье): Суббота, 21 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 20757270 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
JOB PURPOSE
To manage all Regulatory aspects for the product portfolio of RB in country(ies) of responsibility and to ensure that the regulatory and medical activities are compliant to the regulatory requirements for the respective product category, as described in the Healthcare Manual and relevant legislation or regulations.
PRINCIPAL ACCOUNTABILITIES
- Responsible for defining and implementing regulatory strategies and submissions in support of new and existing products within the area of its responsibilities.
- Interfaces with internal and external resources, and international regulatory affiliates to understand complex worldwide regulatory approval requirements.
- Responsible for preparation and submission (either directly or through direct supervision of others) of regulatory documents/applications for new products including but not limited by researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration.
- Responsible for the timely completion of regulatory projects and submission of documentation to regulatory agencies.
- Responsible for compliance with post-market approval regulatory obligations and maintenance of licenses/authorizations for existing products, including review/approval of internal specifications, evaluation of changes in product or processes to determine regulatory impact, and identification of Process Excellence improvements.
- Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes, interprets regulations, gives regulatory insight, advice and support to other departments.
- Evaluate current regulatory processes/procedures and identify and implement improvements consistent with Strategy/Process Excellence Principles.
- Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving.
- Assist the Regional and Global Regulatory team in analysing country product data, Regulatory legislation and providing country specific information.
- Ensure product labelling for all products comply with product dossiers and relevant regulations.
- Develops and maintains current knowledge on price registration requirements and keeps abreast of price registration procedures and changes, interprets regulations, gives regulatory insight, advice and support to other departments.
- Responsible for preparation, submission and tracking of price registration documents/applications for new products and renewal applications.
- Provides a regulatory support in registration samples, reference standards and compounds supply.
KNOWLEDGE AND EXPERIENCE
- Degree in Pharmacy, Chemistry or Medicine
- Experience working in Regulatory & Medical Affairs function in Healthcare, Pharmaceutical related industry.
- Clear understanding of HC regulations in Countries of Cluster, experience in EAC specifics of Regulatory Affairs.
- Experience in Regulatory Affairs for medicines
- Strong communication, organizational, negotiation and interpersonal skills.
- Strong interpersonal and communication skills.
- Ability to effectively negotiate and influence upper management, affiliates, Regulatory agencies, and industry to ensure that regulatory and business needs are met is required.
- Flexibility to provide innovative approaches to gain marketing approvals.
- Fluent Russian and English language skills from Upper - Intermediate.
Откликнуться на эту вакансию: Regulatory Affairs Specialist
Предыдущая вакансия:
Вакансия № 20757268 на должность Senior Pharmacovigilance Specialist от компании ООО Ново Нордиск в городе (населенном пункте) Москва