Sr. RA Specialist -全国base (MJ001258)

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.
协助编辑、发布、存档、跟进和收集与药品监管有关的信息；包括注册递交流程。
2.  Authoring and publishing electronic submissions
撰写和发布电子递交文件
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.
协助研究、分析和沟通与新产品或改良产品，特别是基因与细胞治疗产品相适应的法规信息。
4.  Provide regulatory direction to the sponsor for the development of gene and cell therapy products;
为申办方提供基因与细胞治疗产品开发的法规监管指引。
5.  Assess the risk of proposed regulatory strategies and provides solutions for gene and cell therapy products.
评估拟定的监管策略的风险，并为基因与细胞治疗产品开发提供解决方案。
6.  Communicate with regulatory and government agencies.
与监管部门和政府机构进行沟通。
7.  Other duties as assigned
其他指定的职责
任职要求：
1.Be familiar with rgistration regulations and processes for gene and cell therapy products.
熟悉基因与细胞治疗产品注册法规和流程。
2.Be familiar with FDA/NMPA and other relevant regulatory authorities.
熟悉 FDA/NMPA 及其他相关监管机构。
3.Good command of computer skill for paper works.
熟练使用电脑进行文字编辑工作。
4.At least 2-3 years working experiences in gene and cell therapy products research or registration.
1-3 年基因与细胞治疗产品研发或注册工作经验。
5.Good English in reading, writing and speaking.
良好的英语听说读写能力。
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.
药学学科，生命科学或相关领域，本科以上学历。在基因或细胞治疗产品领域有至少2年的工作经验者优先。