от компании (организации): Российский фонд прямых инвестиций в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Лекарственные препараты"
с заработной платой: по договоренности
Вакансия № 21207406 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 10 августа 2024 года.
Дата обновления вакансии № 21207406 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 № 21207406 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 Manager
Regulatory Affairs Manager
Job Overview:
Under general supervision, prepares, collects and/or reviews regulatory submissions documents for marketing authorization activities either locally or internationally. Provides regulatory support and management for assigned projects.
Essential Functions:
- Registration dossiers preparation for the submissions, variations and renewals and their submission to the competent national regulatory authorities;
- Taking the necessary measures to ensure compliance with the planned timing of product registration, renewal and variations traded products;
- Provides operational support and cooperation to the manufacturing sites/CMOs to ensure the wellbeing of registration procedures and the best possible project outcomes (business correspondence, regulatory strategy, timely informing etc.);
- Establishes relationships with many partners (manufactures, officials, consultants); meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues, manage meetings with Regulatory Agencies;
- Identifies project needs, tracks project timelines, implements partners requests and manages day-to-day workload in collaboration with senior staff, as appropriate;
- Actively participates in project teams with internal and external partners independently and communicates confidently in straightforward matters;
- Support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative;
- Technical writing to complete regulatory and/or technical documents to ensure complete and high-quality regulatory deliverables; communicates regulatory issues and opportunities to partners; and provides strategic regulatory guidance to project teams.
- Performs other tasks or assignments, as delegated by the Senior management.
Qualifications:
- Master's Degree in Life Sciences or related discipline:
- English – upper intermediate;
- At least 2 years relevant experience;
- Good understanding of the Research and Development process (Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable), laws and related guidelines, as appropriate;
- Good, solid interpersonal communication (oral and written) and organization skills;
- Ability to establish and maintain effective working relationships with coworkers, managers and partners;
- Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable;
- Demonstrates self-motivation and enthusiasm;
- Ability to work on several projects, with direction from senior staff as appropriate;
- Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;
- Ability to make decisions on discrete tasks under senior supervision;
- Ability to make adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
- Problems faced are general and may require understanding of broader set of issues;
- Readiness for overwork and irregular working hours.
Откликнуться на эту вакансию: Regulatory Affairs Manager
Предыдущая вакансия:
Вакансия № 21207401 на должность Стажер от компании Job development в городе (населенном пункте) Лобня