от компании (организации): ООО MSD Pharmaceuticals в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Лекарственные препараты"
с заработной платой: по договоренности
Вакансия № 14144561 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 29 сентября 2024 года.
Дата обновления вакансии № 14144561 на сайте Работа в Москве и Московской области (МО, Подмосковье): Пятница, 15 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 14144561 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
MSD’s Regulatory Affairs division helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time.
Purpose of the job:
Provide overall local regulatory leadership, vision, strategy, expertise, and support for the local strategy development of the new products in the market (including product line extension and new indication registration), marketed products (including product registration maintenance as manufacturing or labeling variations, renewals, etc.), new business development and other business projects.
Customers include local Medical/Marketing/Business Management, area and global Regulatory management, the Drug Regulatory Agency.
Responsibilities:
- Preparation and coordination of the company transition to a new Eurasian procedure for registration of medicines.
- Organizing the process of reconciliation of all documents and upgrading procedures in accordance with the new Eurasian registration rules.
- Managing the submission of quality regulatory submissions and obtain regulatory approvals for new chemical entities (NCEs), line extensions (LEXs) and new indications (NIs) to meet the affiliate’s launch plans.
- Establishing appropriate regulatory metrics and measure (country’s) performance with the aim to improve regulatory timelines.
- Managing and ensuring the country Regulatory Plans are in alignment with the country business plan.
- Ensuring appropriate coordination is in place with other functional members of the affiliate and corporate to ensure regulatory timelines are met or exceeded.
- Ensuring that all marketed products in (country) are in compliance with local and corporate regulatory requirements, e.g. labeling, chemistry and manufacturing commitments.
- Ensuring the development of SOPs to manage the regulatory activities (dossier submission and maintenance, dossier archive, interacting with regulators, labeling, packaging, etc.) as per requirements by the Global Regulatory Affairs policies and the local regulations and acceptable Good Regulatory Practices
- Developing and implement a regulatory External Influence strategy to maintain relationships with key regulatory officials and to influence regulators to achieve positive outcomes.
- Managing a team of subordinates according to business goals and KPIs.
- Assigning personnel to cross-functional teams and provide regulatory expertise to ensure regulatory timelines are met or exceeded.
- Ensuring Performance Management Process plans are in place and implemented for the whole regulatory staff.
Requirements:
- Education: Pharmacy, chemistry, biology, medicine. PhD is desirable
- From 5 years experience with Regulatory Affairs area from them at least 2 years on a managerial position
- Knowledge of all Eurasian and Russian registration procedures is mandatory.
- People management skills
- Excellent written and verbal communications skills. Understands and effectively communicates across challenging business environment
- Demonstrates initiative, strategic thinking and creative problem solving in response to the communications challenges and opportunities faced by the company
- Excellent analytical and planning skills
- Advanced English is required
- Established good relationship with Health Authorities and pharmaceutical networks (AIPM etc)
Откликнуться на эту вакансию: Regulatory affairs manager
Предыдущая вакансия:
Вакансия № 14144549 на должность Повар от компании ЗАО Санаторий Истра в городе (населенном пункте) Истра