от компании (организации): Abbott Laboratories в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Регистратура"
с заработной платой: по договоренности
Вакансия № 18692376 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 16 сентября 2024 года.
Дата обновления вакансии № 18692376 на сайте Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 23 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 18692376 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 Manager
Regulatory Manager
Abbott, Moscow
Principal responsibilities:
Over-all management and execution of assigned regulatory projects on all the steps, which comprises at least:
- Act as a knowledge source for headquarters in Russian/ EAEU regulatory requirements area
- Review of regulatory documentation prepared by global regulatory department and by business partners, identify gaps and achieve their elimination
- Prepare of the dossiers (eCTD) for assigned products and submit them in line with the regulatory plan
- Prepare local ND and packaging texts (on the based of analytical methods)
- Identify potential risks in the assigned project and propose solutions to mitigate them
- Organize and hold regular phone and face-to-face meetings with headquarters and partners
- Take part in process of DD (RA dossiers; eСTD format)
- Work with global data bases
- Prepare necessary reports for local management and HQ
- Prepare PIL and variations (on the based CCDS/SmPC)
- Track of regulatory procedure
- 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 regulatory authorities.
- Track changes in local and EAEU regulatory requirements and ensure compatibility of MAAs.
Support of other departments (logistics, commercial, marketing, business development, medical etc.) with RA information
Requirements:
Qualifications:
(What academic/professional qualifications does the individual need)
Required
- Chemical/Pharmaceutical/Medical University Degree
Knowledge/Experience:
(What knowledge or experience of the role or industry does the individual need, e.g. relevant work experience, industry or product knowledge)
Required
- Experience in regulatory affairs in local and/or foreign company – at least 3 years
- Experience in dossier compilation – at least 3 years
- Experience in ND/PIL/AWs preparation
- In depth knowledge of current Russian Regulatory requirements and registration procedures
- Knowledge of EAEU requirements
Skills:
(What specific technical skills does the individual need)
Required
- English knowledge – Intermediate-Upper intermediate writing, reading and communicating orally in general terms and in professional language
- Skilled PC user of office applications (Word, Excel, Power Point)
Competencies:
(main competencies needed for the present position, as: result-orientation, team-work skills , ability to learn)
- Ability to manage registration process from the beginning to the end
- Ability to foresee risks and gaps in regulatory procedure
- 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
Откликнуться на эту вакансию: Regulatory Manager
Предыдущая вакансия:
Вакансия № 18692370 на должность Менеджер по закупкам / импорт-менеджер (Специалист ВЭД) в медицинскую торговую компанию от компании ООО Сэт Фо Мед в городе (населенном пункте) Москва