北京招聘

Key Accountabilities/Responsibilities 主要工作职责：

1. Take line management responsibility and work with InRA and manufacture.
2. Establish relationships with key regulatory authority individuals in SFDA and their advisors.
3. Ensure all translating and compiling dossiers are correct and in compliance with Chinese regulation and effectively summarize professional report in verbal and written for drug registration.
4. Solve the problem arise from the product registration procedure to get the approvals timely in uncertainly regulatory environment within China.
5. Coordinate with Manufacture Site and Regulatory Affairs Department.
6. Provide regulatory support to GSK manufacture site to ensure technical department to generate data according to regulation requirements in China.
7. Provide regulatory support to the other departments or teams in explaining Chinese regulation to InRA and give input as their requirements.
8. Assist Manager to draw up and review budget.
9. Organize the lab test samples supply in the manufacture site.
10. Manage the custom release application of the import samples for regulatory use and solve the problems timely.


Qualifications/Requirements: (Education / Experience / Competencies)
申请资格 / 职位要求：(教育背景 / 工作经验 / 知识与技能)
1. Bachelor degree with medical, pharmacy or related background
2. Good leadership and people management skills
3. Proven ability to communicate (written/verbal) in English
4. Demonstrated ability in effective communication internally and externally
5. Strong capability in problem solving especially in emergency

葛兰素史克（中国）投资有限公司支持部门是与处方药、疫苗等业务部门并列的区域性部门，由人力资源（含行政）、财务（含采购）、IT、法律事务、政府事务、公共关系等部门组成，为中国内陆及香港地区的所有业务部门提供运营支持、规范指导和后勤保障。支持部门通过合理的资源配置和统一的流程规范制定，使各业务部门实现资源共享，业务经营有章可循。同时，支持部门为业务部门提供快捷有效的共享服务，协调并促进不同业务部门之间的沟通与合作，共同为实现“让人们做到更多，感觉更舒适，生活更长久”的使命而不懈努力。