Regulatory Affairs Manager

Вакансия № 1662984 от компании АО Bayer на Электронной Службе Занятости Населения Москвы.

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☑ 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 № 1662984 добавлено в базу данных: Вторник, 11 марта 2025 года.

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

☑ Статистика предложения работы № 1662984:

Прочитано соискателями - 306 раз(а);
Отправлено откликов - 0 раз(а);

☑ Репутация компании "АО Bayer":

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☑ Подробности о вакантном месте:

Bayer is looking for a Regulatory Affairs Manager.

Responsibilities:

Monitors Russian rules of registration and quality control of medicinal products.
Supports contacts with Ministry of Public Health, Pharmacological committee, Pharmacopeial committee, FSA "Therapeutic Products Regulatory Research Center" and other authorities and the organizations participating in registration, expertise and quality control of medicinal products;
Works out registration / re-registrations plan together with Head of Regulatory Affairs;
Ensures duly registration / re-registration of product portfolio of the company, subsidiaries and if necessary companies-partners defined by Head of Regulatory Affairs in Russia:
Ensures timely modification in ND and application instruction when necessary under laws and other normative acts accepted in Russia;
With the purposes of timely certification ensures correspondence of quality certificate, instruction, packing and marking approved by ND;
Checks transfers of ND, quality certificate, packing materials marking, application instructions (structure, description, issue form, packing, storage terms and conditions). Supervises correspondence of quality certificate to the standard documentation;
Participates in development of Russian packing, labeling, application instructions and insert (checks conformity of ND and, if necessary, puts relevant corrective amendments);
Consults other departments on issues concerning certification of medicinal products (including occurrence of claims) according to the list defined by Head of Regulatory Affairs.

Requirements:

University degree in natural science (pharmacy is preferable);
Minimum 3 years of work experience in medical products registration;
High level of knowledge of the Company and competitors product portfolio;
Good knowledge of legislative and other standard documents in the sphere of registration and certification of pharmaceutical products;
Analytical and conception thinking;
Punctuality and duty performance;
Ability to work under stress;
Good command of English (both oral and written);
Advanced user of PC: MS Windows, Lotus Notes, Internet.
Readiness to business travel.
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