Regulatory Strategy and Policy Affairs Manager

☑ Основной блок:

Опыт работы: 3–6 лет.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

☑ Актуальность объявления:

Это объявление № 108920 добавлено в базу данных: Пятница, 14 марта 2025 года.

Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.

☑ Репутация компании "АНКОР Медицина и фармация":

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☑ Подробности о вакантном месте:

Large foreign medical company is looking for Regulatory Strategy and Policy Affairs Manager who will be responsible for Strategic Regulatory Affairs projects:

• Portfolio Transformation
• EAEU re-registration
• Regulatory Policy affairs initiatives

• It implies leading, coordination and timely and successful execution of Portfolio Transformation project: understand timing and nature of changes based on information from EMEA Transformational team per product category, creation of schedule of local changes implementation, follow-up with specialists performing regulatory projects, monitoring of budget and timeliness, communication to business, local RA and RA international.
• Leading of the Company Portfolio re-registration in accordance to EEU requirements: creation of project plan based on understanding of potential bottle necks and open issues of new regulation, building assumptions, urgency and criticality for business of the regulatory projects. Estimation of the budget and resources required, monitoring of the budget and timeliness, communication with all related functions and departments.
• Deep understanding of current and upcoming regulation, area of potential changes to support the regulatory bodies and manufacturers in the process of transparent and effective regulatory field creation, to ensure flawless re-registration and product circulation of the Company Portfolio. Flag and raise potential issues, collaborate with Government Affairs, IMEDA and other partners to create discussion platforms with the regulators and effectively address them. Collaborate with EMEA and Global Reglatory Policy and Government Affairs team to get good understanding of EU and US regulations to find opportunities for harmonization of the regulation in favor of the health care system, patients and industry players

Requirements:

• Higher education (educational background in engineering is a strong advantage)
• 5 years of deep expertise in medical devices registration, dossier update and registration update processes
• Good knowledge of the current regulation in Russia and CIS and upcoming EEU regulation, knowledge of EU and US regulation as an advantage
• Expertise in general business processes execution
• Project Management Experience
• Experience in shaping environment initiatives
• Strong in data gathering & interpretation, analytical, attentive to details
• Goal oriented, responsible, dedicated
• Excellent communication skills, good in listening, good problem-solving and influential skills
• Constructive team player
• Fluent English
• Good command in XL and Power Point

☑ О компании:

Логотип (эмблема, торговая марка, бренд) компании:

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