北京招聘

Key Accountabilities/Responsibilities 主要工作职责：
1. Establish, maintain and develop good relationships with the State Food & Drug Administration (SFDA), to facilitate and expedite regulatory approvals and as required with other regulatory authorities (CDE, NICPBP).
2. Advise and resolve specific issues to achieve agreed milestones and ensure that submitted documentation meets SDA and GSK requirements.
3. Ensure that Regulatory Affairs International (InRA) is kept fully informed on the current regulatory status of all assigned products.
4. Ensure that Import product labeling and PI is consistent with SDA guidelines and requirements.
5. Order, translate, compile and prepare registration dossiers into an effective, professional document for submission to SFDA.
6. Draft for approval by the Manager, local prescribing information (PI) that it is both competitive and fully conforms with SDA and GSK requirements.
7. Collect and communicate to the Manager any information that relates to the registration and administration of medicines in China; including new legislation, changes to the regulatory requirements, guidelines etc.
8. As required co-ordinate activities with InRA.
9. Provide professional RA input for cross function projects


Qualifications/Requirements:
申请资格 / 职位要求：
? Possesses a Bachelor degree in microbiopharmaceutics or relevant speciality
? 1-2 years of regulatory work
? Proven ability to communicate (written/oral) in English
? Good verbal and written communication skills
? Expert knowledge of regulatory policies and registration processes in China
? Proven competency with the following computer software: Word, Powerpoint, Microsoft Project and Excel

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。