南京招聘

1. Screening various sources for relevant therapeutic area-related regulatory developments and information on regulatory-related competitor activities. 筛选有关治疗领域相关法规发展和法规相关竞争活动信息的各种来源。

2. Appropriately communicate the information and its potential impact within GRA and to other relevant functions within the company. 在GRA内部和公司其他相关部门之间适当地沟通信息及其潜在影响。

3. Coordinate and guide review of relevant draft guidelines by functions and / or Global Regulatory Affairs including coordination of review of the generated company positions. 根据职能部门和/或全球监管事务协调和指导相关指南草案的审查，包括协调对产生的公司职位的审查。

4. Ensure that alignment on one position is obtained between all affected functions and regions. 确保所有受影响的函数和区域在一个位置上对齐。

5. Maintain an effective Regulatory Intelligence database, providing Regulatory Intelligence services for development projects and for marketed products regarding regulatory requirements and external regulatory experts to allow GRA functions to anticipate and effectively implement new regulatory compliance obligations. 维护有效的监管情报数据库，为开发项目和上市产品提供有关监管要求的监管情报服务，并聘请外部监管专家，使GRA能够预测并有效履行新的监管合规义务。

6. Assist Regulatory manager for implementing and delivering regulatory submission and approval, and maintenance for new products/post-marketing projects within agreed timeline. Ensure regulatory compliance with government policy and company required SOPs. 协助法规经理在规定的时间内完成法规的提交和批准，并维护新产品/售后项目。确保遵守政府政策和公司要求的sop。

7. Establish and maintain close relationship with NMPA/ CDE/ NIFDC and other appropriate regulatory agencies and under manager’s guidance have a close/ effective communication with relevant regulatory agencies to consult regulatory strategy, determine status and facilitate the approvals of applications submitted to NMPA. Establish relationship with HA and collaborate with key stakeholders in the local, regional and global organization. 与NMPA/ CDE/ NIFDC和其他相关监管机构建立并保持密切的关系，在经理的指导下与相关监管机构进行密切/有效的沟通，以咨询监管策略，确定状态，促进提交给NMPA的申请的批准。与医管局建立关系，并与本地、区域及全球机构的主要持份者合作。

Maintain good knowledge in general/product specific scientific and regulatory requirement/ process. Take the responsible for implementation of policy intelligence management as conducted by manager, to ensure local and global team is well informed with the regulatory update and maintain strong working relationship and communications with cross-functions to provide regulatory and policy information to support development strategy. 对一般/产品特定的科学和法规要求/流程有良好的了解。负责执行经理制定的政策情报管理，确保本地和全球团队掌握法规更新，并与各职能部门保持良好的工作关系和沟通，提供法规和政策信息以支持发展战略。

万宝盛华大中华有限公司，1997年服务启航于香港和台湾。迄今服务覆盖上海、北京、广州、深圳等逾20座直营城市。我们的大股东万宝盛华全球（ManpowerGroup Inc. NYSE:***）是全球人力资源解决方案领导者，拥有70年服务经验。凭借万宝盛华全球的声誉及行业经验，万宝盛华大中华深耕本土20余年。2015年，万宝盛华大中华战略联盟中信产业基金，总部落地上海，服务网络覆盖两岸三地130余城市逾两万家企业。我们始终致力于释放人才的发展潜能，凭借灵活用工、人才寻猎、招聘流程外包、人才管理及培训发展等人力资源综合解决方案，广受业界赞誉，屡次荣膺“亚太人力资源领军企业”。