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1.??Assist with the compilation, distribution, storage, tracking and retrieval of information relevant to the regulatory process of drug products, including the regulatory submission process.
協(xié)助編輯、發(fā)布、存檔、跟進和收集與藥品監(jiān)管有關(guān)的信息；包括注冊遞交流程。
2.??Authoring and publishing electronic submissions
撰寫和發(fā)布電子遞交文件
3.??Assist in researching, analysing and communicating information on the appropriate regulatory pathway for new or modified products, especially for gene and cell therapy products.
協(xié)助研究、分析和溝通與新產(chǎn)品或改良產(chǎn)品，特別是基因與細(xì)胞治療產(chǎn)品相適應(yīng)的法規(guī)信息。
4.??Provide regulatory direction to the sponsor for the development of gene and cell therapy products;
為申辦方提供基因與細(xì)胞治療產(chǎn)品開發(fā)的法規(guī)監(jiān)管指引。
5.??Assess the risk of proposed regulatory strategies and provides solutions for gene and cell therapy products.
評估擬定的監(jiān)管策略的風(fēng)險，并為基因與細(xì)胞治療產(chǎn)品開發(fā)提供解決方案。
6.??Communicate with regulatory and government agencies.
與監(jiān)管部門和政府機構(gòu)進行溝通。
7.??Other duties as assigned
其他指定的職責(zé)
任職要求：
1.Be familiar with rgistration regulations and processes for gene and cell therapy products.
熟悉基因與細(xì)胞治療產(chǎn)品注冊法規(guī)和流程。
2.Be familiar with FDA/NMPA and other relevant regulatory authorities.
熟悉 FDA/NMPA 及其他相關(guān)監(jiān)管機構(gòu)。
3.Good command of computer skill for paper works.
熟練使用電腦進行文字編輯工作。
4.At least 2-3 years working experiences in gene and cell therapy products research or registration.
1-3 年基因與細(xì)胞治療產(chǎn)品研發(fā)或注冊工作經(jīng)驗。
5.Good English in reading, writing and speaking.
良好的英語聽說讀寫能力。
6.Pharmaceutical science, life sciences or relevant major with at least Bachelor’s degree.A minimum of 2 years of experience in gene and cell therapy products research or registration preferred.
藥學(xué)學(xué)科，生命科學(xué)或相關(guān)領(lǐng)域，本科以上學(xué)歷。在基因或細(xì)胞治療產(chǎn)品領(lǐng)域有至少2年的工作經(jīng)驗者優(yōu)先。