公司職位
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職位要求: |
Job Highlights: Job Description: operating duty Establishment of drug quality management system, supervision of drug delivery, delivery, quality management and other matters. Participate in the formulation of registration and application strategies and plans according to the company's product characteristics and research and development stage, collect, sort out and submit drug registration and application materials according to the relevant requirements of domestic and foreign drug regulatory agencies, and file them in time after submission. Responsible for the follow-up of drug registration progress, good and close communication with drug regulatory agencies, responsible for the transmission and reply of information, and ensuring the timely filing of reply information and documents. Local medical service business cooperation, daily contact between customers and partners, response to customer inquiries, and reception of customer visits. Data statistics and analysis, including but not limited to statistics of patient complaints feedback information, risk analysis of various failure modes, regular trend and review analysis of complaint data, and formation of reports. Cooperate in other related work.
Job requirements: Bachelor degree or above, major in pharmacy or other related majors. Qualified as a licensed pharmacist (Hong Kong) Understand the laws and regulations related to drug quality management, and have relevant experience in participating in the construction of relevant management systems. Be familiar with the policies and regulations, technical requirements, application process and application data requirements related to domestic drug registration, have a certain understanding of the laws and regulations related to drug registration in foreign countries (such as the United States and the European Union), and have the ability to retrieve and analyze drug registration information. Independent access to relevant literature at home and abroad, excellent English listening, reading and writing.
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