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Assistant to Regulatory Department

Работодатель: Abbott Laboratories (0 вакансий)

Abbott Laboratories SA Business Centre Avalon, 38a, Oybek str, 100015, Tashkent, Uzbekistan

Требования:

• Education: University Degree.
• Experience in the field of registration of medicines and / or medical devices (desirable).
• English Intermediate.
• Proficient computer skills (Word, Excel, PowerPoint).
• Organized, scrupulous, punctual, initiative.

Обязанности:

• Develop and provide medical and technical information relating to the company's marketed products to the company, its customers, and the government.
• Provide medical and operational support to marketed products in the assigned portfolio.
• Provide, review, and ensure medical activities (including promotional support, operational reviews and planning, and clinical protocols) are implemented in alignment with product strategies, and in compliance with regulatory policies and guidelines.
• Prepare final study reports and publications.
• Sign off on product safety reviews.
• Possess basic knowledge in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Interact with regulatory agency to expedite approval of pending registration.
• Participate in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
• Ensure timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
• Serve as regulatory liaison throughout product lifecycle.
• Serve as regulatory representative to marketing, research teams and regulatory agencies.
• Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Условия работы:

• Interesting work in the multinational pharmaceutical company.
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