от компании (организации): Besins Healthcare Rus в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Лекарственные препараты"
с заработной платой: по договоренности
Вакансия № 12976875 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 11 ноября 2024 года.
Дата обновления вакансии № 12976875 на сайте Работа в Москве и Московской области (МО, Подмосковье): Четверг, 14 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 12976875 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
Main responsibilities:
- Responsibility for developing a comprehensive registration strategy.
- Documents Request from manufactures, dossier holders, etc.
- Responsibility for insuring earliest possible registration of all new or in-line products including GMP inspections, variations, formulations and/or strengths, other possible changes according to adopted registration strategies (and company's high ethical standards policy).
- Reviewing registration files and all related documentation of the Company's products and preparing such documentation in line with local normative regulations.
- Preparing Application Forms and other documentation for filing and registration of new products. Ensuring that all documentation, samples, commercial packs and other items are provided to relevant agencies as needed.
- Cooperation with consulting and translation agencies.
- Establishing and maintaining good working relationships with all involved regulatory and other institutions. Keeping track of new normative documents related to registration of medicines.
- Price registration/re-registration of the essential drug list.
- Responsible for the budget of the Regulatory function.
- Influence through knowledge power to guide business managers at every stage during product planning to product launch.
- Maintain and update Registration Database.
- Preparing and reviewing package labels and inserts for Company's respective new and in-line products registered in the country.
- Plan, organize and implement strategies and activities required to procure Regulatory approval for new and modified product lines.
- Be accountable for business requests and needs.
Requirements:
- Higher education (educational background in pharma or bio-engineering is a strong advantage).
- At least 2 years of experience in Regulatory Affairs (pharmaceuticals, medical equipment,).
- English – Upper-Intermediate (written, spoken).
- Good knowledge of the current regulation in Russia and CIS and upcoming EEU regulation.
- Knowledge of EU and US regulation as an advantage.
- Personality: team player, well organized, attentive to details, enthusiastic, quick learner, attentive to details.
- Excellent communication skills.
- Ability to work with big amount of information.
Откликнуться на эту вакансию: Regulatory Affairs Manager
Предыдущая вакансия:
Вакансия № 12976874 на должность Менеджер по туризму (Ново-переделкино, Переделкино Ближнее, Внуково) от компании Слетать.ру (ООО Отпуск) в городе (населенном пункте) Москва