上海招聘

Position Summary
1.Understand and adhere to the regulatory regulations and technical guidance CFDA announced for the assigned category of healthcare products.
2.Project timeline set up and update according to company and client’s requirement
3.Prepare regulatory submission document packages according to the R&D files provided by the clients and the CFDA regulations and guidance
4.Arrange the sample testing in China required by CFDA, including samples ordering, product specification and method writing, sample testing follow up and on site technical assistant to CFDA certified center, testing report review and discussion with CFDA certified center.
5.Communicate with client’s technical team to solve the issue occurred in the testing process.
6.Regulatory documents submission, tracking and follow up with SFDA until the final registration approval in China.
7.Understand the technical questions raised by the reviewer in CFDA on the product efficacy and safety. Can clearly communicate these technical questions to the R&D team of the clients and assist to answer these technical questions in a professional way.
8.Proactive project management
9.Foster constructive and professional working relationships with all related government authorities.
10.Forster constructive and professional working relationships with all project related clients.
11.Motivate and guide his/her team to ensure successful completion of the project.

Qualifications
Minimum Bachelor's degree on either pharmaceutical, chemistry, pharmacologist or related background.
Minimum 3-5 years experience in performing regulatory submissions in Drug or IVD.
Ability to work in a fast-paced, high-output, team-oriented environment. Proficient in Microsoft Office Suite and other appropriate project management software.

职位描述：
1.了解并熟悉药品注册管理办法及相关指导原则
2.根据要求设定项目时间表并定期更新
3.依据要求准备注册递交资料
4.安排样品检测包括：定样、产品标准及检测方法撰写、检测跟踪等
5.与客户沟通解决注册中的技术问题
6.负责项目的递交、跟催
7.具有一定的沟通能力，能够理解审评员所提出的问题并能准确的进行反馈
8.具有一定的项目管理能力
9.与监管部门保持良好的关系
10.良好的客户维护能力.
11.帮助并指导其团队成员

岗位要求：
药学、化学、药理大学本科学历或相关专业的本科学历
3-5年从事相关注册经验
能够在多样化的工作环境中工作
熟练使用Office等相关软件

启通医药技术咨询（上海）有限公司（ChinaGate Company Ltd.）是一家专业提供健康医疗领域产品研发，产品注册咨询服务和临床试验专业服务的合同研究组织（CRO）。 ChinaGate 是全球500强美国联合健康集团(United Health Group)在中国的全资子公司。

美国联合健康集团是在医疗健康领域领先的企业，在全球拥有近8万员工，为全球近7500万用户提供服务。其业务覆盖健康保险，医疗健康管理咨询及服务等各个领域。2011年在《财富》杂志世界500强排名中位列第62位。

ChinaGate作为United Health Group在中国的子公司，在中国为世界各个国家的医药健康企业提供专业的技术咨询服务。经过十年的不懈努力，目前ChinaGate拥有经验丰富的管理团队、资深的技术人员和精通政策法规的专业人员。业务范围涵盖了药品、医疗器械、体外诊断试剂、化妆品及保健食品领域。与众多国内外知名制药、医疗器械、诊断试剂等公司建立了良好的合作伙伴关系。在行业发展中我们力求为客户提供高专业水准的服务，成为每一位客户的长期战略合作伙伴。
公司主页：
www.unitedhealthgroup.com,
www.chinagate-healthcare.com