职位描述
工作性质与职责范围：
1)Participates in the preparation and execution of regulatory projects necessary to achieve successful registration of company products in order to support affiliate’s business goals and corporate objectives. 参与注册项目的筹备和实施，成功实现公司产品的注册以支持公司的经营目标和企业目标。
2)Assistant to RA director or manager, interactions and negotiations with regulatory bodies (CFDA, CDE, NIFDC etc.,) in China. 协助注册总监或经理，参与中国药品管理部门的日常交流（国家食品药品监督管 理局、CDE、 NIFDC等）。
主要职责
1)Manages, prepares and submits regulatory applications & questions within specified timeline in China. 在规定的时间表内完成产品的注册管理、申请和批准。
2)Assistant to the regulatory manger, undertakes interactions and negotiations with Regulatory Authorities to secure and optimise regulatory approvals concordant with strategic company goals. 协助经理在产品注册过程中的HA之间的交流，确保与公司战略目标一致，优化注册的批准。
3)Plans and prioritizes maintenance activities and regulatory variations to ensure products compliant with China regulatory requirements. 维护上市产品的生命周期确保满足中国法规要求以及市场需求。
4)Reviews labeling and packaging, promotional and educational material in line with regulatory and company compliance requirements. 审核产品说明书及推广信息符合国家及公司合规要求。
5)Assistant to the regulatory director or manager, provides information to the assigned project planning and regulatory strategic plans in cooperation with global/regional/local staff to achieve and optimize strategic company goals. 协助注册总监或经理，向当地或总部人员提供相关产品信息，以利于制定产品进入中国市场的有竞争力的研发策略。
6)Keeps up-to-date with government legislation relating to regulatory affairs in China. 确保产品信息符合国家的管理要求以及迅速调整适应法规变化。
7)Contributes to company systems development, maintain regulatory document management systems.完善产品注册档案及其相关管理系统。
岗位要求：
Education 学历
?University degree in pharmacy, science, biomedical/life science. Higher degree desirable.要求药剂学学士、生物/生命科学学士学位或以上学历
Experience经验
?more than 3 years regulatory affairs experience in the pharmaceutical field. Experience with Bio/OTC products is desirable. 3年以上处方药领域产品注册事务经验。有 Bio/OTC 产品经验者优先。
?Experience with new chemical entities (NCE) and/or biopharmaceutical applications, knowledge and understanding of drug development processes. Preferably with a multinational pharmaceutical company. Proficiency with China regulatory affairs processes and regulations. 了解 NCE 和/ 或生物制药的应用和知识；了解药品开发流程。跨国制药公司经验优先；了解中国注册事务流程法规要求。
