osition Purpose
· Assist line manager to complete registration projects for new products, variations of marketed products and license renewals within the set timeframe and conduct in compliance with local regulatory agency requirements as well as relevant Pfizer SOPs.
· Keep close working relationship with HA officials and KOLs.
· Interact with other functional team closely.

Primary Responsibilities
· Assist line manager to complete registration projects for new products, variations of marketed products and license renewals within the set timeframe and conduct in compliance with local regulatory agency requirements as well as relevant Pfizer SOPs.
· Closely follow up submission, QC testing, evaluation and approval in SFDA, CDE and official labs.
· Keep communication with HQ and other internal functional teams.
· Keep alert on regulatory intelligence.
· Develop and improve good working relationship with HA and KOLs.
· Report to line management regularly.
· Maintain and update the Local Product Document (labeling) and Artworks in accordance with relevant regulations and Pfizer SOPs.

Technical Skill Requirements
· Knowledge of drug development process, laws, regulations and practices affecting the pharmaceutical industry
· Project management skill
· Good skills on communication, collaboration, negotiation and problem solving.
· Good English skill in both spoken and written.
· Good computer skill.

Qualifications (i.e., preferred education, experience, attributes)
· Managerial
N/A
· Certifications
English: CET-6 and EF level-12
Computer skills: 2nd level NCRE proficient of Microsoft office software.
· Education
A bachelor degree major in chemistry, pharmaceutics, biology, medical or a related life-science discipline, or equivalent. A master degree or above is preferable.
· Experience
At least 1.5 years drug registration experience in pharmaceutical companies.

自20世纪80年代进入中国以来，辉瑞始终承诺并致力于参与促进中国经济繁荣发展和提高人民健康水平。辉瑞通过不断引进创新药物、开展面向医务工作者专业培训和社会健康意识普及教育等活动，积极参与支持各项社会公益事业，全力支持中国卫生健康事业的深入发展。
1989年，辉瑞在大连建立现代化的工厂。 为实现在中国的长期发展, 辉瑞于1997年在北京成立了管理中心。2004年，辉瑞在上海成立了中国区总部和辉瑞投资有限公司。基于中国所拥有的才华横溢的科研人员群体，辉瑞中国研发中心于2005 年在上海成立。2007年，辉瑞全球财务共享服务中心（GFSS）在大连设立了亚太财务中心，该中心是GFSS位于全球的三个运营中心之一，负责处理辉瑞亚太区市场的会计业务。
目前，辉瑞中国共有近4,000名员工，在大连、苏州和无锡拥有4个现代化制药厂，业务范围涵盖全国100多个主要城市。辉瑞也是在华投资的跨国制药企业之一,累计投资额已超过5亿美元。