от компании (организации): Brunel Russia в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Регистратура"
с заработной платой: по договоренности
Вакансия № 10733107 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 3 августа 2024 года.
Дата обновления вакансии № 10733107 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 22 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 10733107 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 Affairs Specialist
Vacancy is opened in the company producing original drugs in the field of oncology, hepatology and HIV
Responsibilities:
• A comprehensive range of regulatory activities as described under regulatory affairs.
• Obtaining and maintaining the necessary regulatory-associated licences and obligations with Russia and EAEU agencies in order to allow Company to conduct its business.
• Submission and coordination of distribution of Dear Healthcare Provider Letters.
• Provision of accurate English translations of all agencies correspondence and labelling for company’s products in Russia and EAEU.
• Helps ensure compliance with local law and regulation and consistency with global procedural documents including acting as a subject matter expert with the execution of audits and inspections within the affiliate.
• Represents Regulatory Function at internal and external meetings or internal working parties.
Regulatory Affairs:
• Responsible for preparing regulatory submissions which require cross-function interactions with internal and external partners (as appropriate) for investigational and commercial products for Russia and EAEU in line with local and international requirements and company policies and procedures.
• Responsible for new product registration and GMP applications submissions for assigned products, which may include routine submissions (e.g., safety reports, DSUR, PSUR/PBRER, and Registration Renewal) as well as post approval variations and labeling updates, as needed.
• Contribute to preparation and filing of new registrations or CTA submissions, as required.
• Provides regulatory support to development and/or revision of product labeling (e.g., local labeling) in accordance with Russian and EAEU requirements and in alignment with company policies and standards.
• Ensures compliant labeling for medicinal products and manage timely updates for assigned products.
• Promotional material review, approval for assigned products.
• Participate in team meetings whenever required for assigned products; responsible for development of regulatory strategy and presentation of ongoing project updates.
• Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge.
• Initiates or contribute to local process improvements, which have an impact on the working of the Regulatory Affairs function or other departments.
Requirements:
• Pharmacist, Biotechnology, Pharmacist or Chemist education
• Minimum 3 years of relevant experience in Regulatory Affairs or related field.
• Excellent organizational, communication and interpersonal skills.
• Good knowledge and proven experience in understanding and implementing regulatory requirements, including ICH requirements, Russian and EAEU requirements for assigned territories.
• Good working knowledge regarding Russian and EAEU HAs (people, system, processes and requirements) essential.
• English - upper-intermediate
Conditions:
- Salary is discussed with a successful candidate
- Annual bonus
- Food payment
- Life insurance
- Payment of transport
- a contract for 1 year
Откликнуться на эту вакансию: Regulatory Affairs Specialist
Предыдущая вакансия:
Вакансия № 10733103 на должность Администратор в клинику косметологии и пластической хирургии от компании Клиника косметологии и пластической хирургии АрбатЭстетик в городе (населенном пункте) Москва