от компании (организации): Abbott Laboratories в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 21859269 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Пятница, 11 октября 2024 года.
Дата обновления вакансии № 21859269 на сайте Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 11 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 21859269 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 (Established Pharmaceuticals Division)
For 130 years Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, minimally invasive medical devices, coronary stents, nutritionals and branded generic medicines. We help people with diabetes effectively manage it without painful finger pricks.
Abbott is one of the most diversified companies in healthcare. Our 109,000 colleagues serve people in more than 160 countries.
Dedicated to making the world a healthier place, our pharmaceuticals business brings trusted brands to broader populations in developing countries around the world. We offer a growing portfolio of high-quality, trusted medicines.
We are now looking for Regulatory Affairs Specialist (Established Pharmaceuticals Division).
Principal responsibilities:
- Act as a knowledge source for headquarters in Russian regulatory requirements area
- Organize and hold regular phone and face-to-face meetings with headquarters and partners
- Prepare of the dossiers (eCTD) for assigned products and submit them in line with the regulatory plan
- Review of regulatory documentation prepared by global regulatory department and by business partners, identify gaps and achieve their elimination
- Prepare ND/PIL and packaging texts
- Track of regulatory procedure in the state register
- Maintain MAs through renewals and variations
- Actively participate in obtaining necessary information/supplies from internal (or external) providers required for planning and performing regulatory activities
- Prepare responses to deficiency letters received from the Russian regulatory authorities.
- Track changes in local and EAEU regulatory requirements and ensure compatibility of MAAs/CTAs to them.
Key Requirements:
- Chemical/Pharmaceutical/Medical University Degree
- Experience in regulatory affairs in local or foreign company
- In depth knowledge of current Russian Regulatory requirements
- English knowledge - intermediate writing, reading and communicating orally in general terms and in professional language
- Skilled PC user of office applications (Word, Excel, Power Point)
- Initiative, result-oriented and well organized
- Excellent communication skills
- Attentive to details
- Analytical skills (ability to review and understand extensive regulatory documentation)
- Synthetic skills (ability to formulate sound and information- based proposal for decision making)
- Ability to co-ordinate basic activities
- Adaptation and flexibility
- Knowledge of EAEU requirements
Откликнуться на эту вакансию: Regulatory Affairs Specialist (Established Pharmaceuticals Division)
Предыдущая вакансия:
Вакансия № 21859255 на должность Ведущий инженер сопровождения (Cистемы мониторинга ИС) от компании Иннотех, Группа компаний в городе (населенном пункте) Москва