EAEU Regulatory Affairs manager

☑ Основы вакансии:

Опыт работы: 3–6 лет.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Республика Казахстан, Алматы.

☑ Актуальность объявления:

Это объявление № 28472244 добавлено в базу данных: Понедельник, 13 мая 2024 года.

Дата его обновления на этом интернет-ресурсе: Суббота, 18 мая 2024 года.

☑ Репутация компании "ТОО Такеда Казахстан":

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☑ Подробности о вакантном месте:

Required Qualification:

I. Education - Higher Pharmaceutical/Chemical/Medical

II. Experience:

1) registration of drugs, medical devises on the territory of EAEU countries (Kazakhstan, Russia, Belarus, Armenia, Kyrgyzstan): 2 - 3 years;

2) registration of drugs, medical devises on the territory of Kazakhstan: 3 - 4 years

III. Knowledge of regulatory legislation the EAEU

Required competencies and interests:

• Project planning and execution ability
• Decision-making skill
• Strategic thinking
• Looking for bringing the innovations to patients
• Looking for building effective and inclusive relationships
• Looking for realization of ambitions in multinational pharmaceutical company
• Looking for result achievements via collaborative work with multiple functions across countries and nationalities

Responsibilities:

• The EAEU (Europe-Asian Economic Union) Regulatory Affairs manager is responsible for execution of strategy of registration of company’s medicinal products across EAEU countries (including all types of regulatory submissions drugs and medical devises in accordance with the legislation of the EAEU) aimed at maintaining the relevance of registration certificates.
• Ensures continuous access of patients to therapy by developing and implementing a regulatory submission planning for the successful completion of the company's product registration procedures and ensure continuous access of patients to therapy.
• To be a part of the regulatory local team responsible for arrangement of development, evaluation and periodical review the SOPs of the regulatory department.
• To set up and manage effective collaboration with quality, medical, commercial and other local functions aimed to provide timely and clear regulatory information and to support good performance of local team.
• Take appropriate actions to reach personal, company’s and regulatory KPIs.
• To be a part of local regulatory budget planning.
• To be an active participant of self-inspections and external audits
• Arrangement and keeping updated appropriate activities of promo-and non-promo materials approval with respect of Takeda’s regulatory and compliance politics.
• Monitoring of the regulatory laws of EAEU to identify the change of trends and corresponding correction of work plans to the continuity of drug supplies to EAEU countries.
• To carry out regular assessments of upcoming changes of manufacturing and quality processes as of life cycle management of products.
• Management of complex cross-functional projects .
• Compliance with and provision of compliance within the area of his/her liability with Kazakhstan laws, business conduct rules, business ethical principles.

☑ О компании:

Логотип (эмблема, торговая марка, бренд) компании:

Сфера деятельности компании: Медицина, фармацевтика, аптеки; .

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