岗位职责：

1、 保证药事法规和政策变化对公司产品或业务的影响得到充分的评估，并与注册策略负责人和相关部门成员进行充分的沟通, 对法规和政策变化可能带来的潜在问题给予充分的说明;

Ensure that impacts of changes in regulations and policies on the company's products or business are fully evaluated. Fully communicate with regulatory strategists and relevant functional members , and fully explain the potential problems that may be brought about by changes in regulations and policies;

2、 负责与CCFDIE战略合作项目的筛选、合同审批、执行、以及结果评估等；

Responsible for strategic cooperation projects with CCFDIE such as project selection, contract approval, implementation, and result evaluation;

3、 负责药事情报相关活动，包括收集、报告, 分享和存档最新的药事法规和政策信息、公司产品的竞品信息、药品监管机构活动及职能和人事变动信息，并进行分析评估，保证任何药事法规和政策的变化尽早得到发现和澄清，政策和情报信息得到系统地收集、整理、归档和交流;

Responsible for intelligence activities, includinging collecting, reporting，distributing and archiving the latest regulations and policies, information of competition products, activities, functions and personnel changes of drug regulatory authorities, and conduct the analysis and assessment. Ensure that any changes in regulations and policies can be found and clarified as soon as possible, and policy and intelligence information can be systematically collected, sorted, filed and exchanged;

4、 向管理层、全球法规事务部、开发总部及其他相关部门报告中国药事政策和情报信息;

Report China pharmaceutical policy and intelligence information to management, Global RA, development division and other relevant departments;

5、 与全球第一开发梯队地区的药事情报和政策负责人建立沟通和协调机制，共同维扩全球药事注册部的立场并分享药事情报和政策信息。

Communicate and coordinate with the regulatory intelligence & police heads of global tier 1 development regions to keep the GRA stand and share the regulatory intelligence & policy information.

6、 与NMPA、药典会、中检院、药审中心、评价中心、检查认证中心、CCFDIE等建立和维持良好的关系和沟通渠道以支持第一三共作为合作伙伴和思想领袖的声誉；

Establish and maintain good relationships and communication channels with NMPA, CPC, NIFDC, CDE, CDR, CFDI, CCFDIE, etc. to support DS reputation as a partner and thought leader;

7、 与RDPAC等行业协会进行充分的沟通与合作，积极参与行业协会的活动；

Fully communicate and cooperate with RDPAC and other industry associations, and actively participate in the activities of industry associations;

8、 为药品监管相关机构和官员提供日本药品监管政策、法规、技术指南和工作流程等相关信息，协调促进中日药品相关部门和行业组织的交流与合作；

Provide relevant information of Japan regulatory policies, regulations, technical guidelines and working procedures for China authorities, coordinating and promoting the exchange and cooperation between China and Japan drug related departments and industry organizations;

9、 积极参与NMPA及其所属机构的新法规和政策的制定，并保证注册策略负责人和相关部门成员得到充分的信息；保证公司的立场或观点得到清晰地反映；

Actively participate in the formulation of new regulations and policies of NMPA and its affiliated institutions, and ensure that the regulatory strategist and the relevant functional members get sufficient information in the company; ensure that the company's position or views are clearly reflected.

10、 与药事情报信息供应商开展合作并进行管理。Collaborate and manage the vendors of regulatory intelligence and policy information service.

资历要求：

• 生物、药学、医学等相关专业硕士及以上学历; 有药品注册和药事法规等培训和工作经历者优先；

Master's degree or above in Biological, Pharmaceutical and Medical related major; drug registration and regulatory intelligence and policy working experience and training experience is preferred

• 8年以上经品注册或药事政策和情报相关经验。

More than 8 years experience in drug registration or regulatory policy and intelligence in biopharmaceutical industry.

• 具有领导力；较强的沟通及表达能力；组织协调能力；

leadership; strong communication and expression skills; organization and coordination ability;

• 熟练的英语听、说、读、写能力(CET6以上)

Proficient in English listening, speaking, reading and writing (CET6 or above)