长沙招聘

Contributes to the adequate management of regulatory activities by supporting development and implementation of CMC related processes and tools on his/her perimeter.
Mission
Submits registration dossiers required for the CEPiA Sales activity in CEPiA China Zone.
Manages Regulatory Affairs (RA) in accordance with local regulation and RA CEPIA Sales strategy.
Contributes to CEPiA Sales RA network with RA CEPiA Sales Corporate, RA CEPiA Sales in Business Units (BU), manufacturing sites and Health Authorities.
Domains of expertise
职位要求：
- Education: University degree in Pharmacy, Chemistry/ Biochemistry.
- Experience & knowledge: Minimum of 5 years in the pharmaceutical industry with knowledge in Regulatory Affairs.
- Core competencies: Background in Pharmaceutical production, Analytics, Quality Assurance and registration regulations.
- Behavior: Good skill in communication.
- Languages: Fluent in both English and Chinese.
Key Contributions & Activities
Maintenance of Regulatory Affairs system/organization of CEPiA Sales for CEPiA China Zone:
· Manages Regulatory Policy of the zone in relation with CEPiA Sales RA Corporate.
· Provides to CEPiA Sales RA Corporate & Regulatory Site Officer with the regulatory strategy to support Change Control process, new projects and site transfers after receipt of the Change Control Request Form (CCRF). Assures the follow up of the decisions.
· Ensures adequate management of registration dossiers: write/translate/compile & especially ensures that the content of the document provided by manufacturing sites remains unchanged in the submitted dossiers. Ensures submission of dossiers to Health Authorities according CEPiA Sales RA Corporate strategy & agreed planning.
· Coordinates with CEPiA Sales RA Corporate & manufacturing site answers to questions from Health Authorities(HA).
· Follow-up & tracking of Health Authorities approval & informs CEPiA Sales RA Corporate, CEPiA Sales RA BU & manufacturing site.
· Assures the follow-up & contributes to new or updated monographs in the Pharmacopoeias of the Zone (Pharmacopoeia evolution).
Management of interfaces with RA CEPIA Corporate, RA CEPIA in the BU, Sanofi manufacturing sites, Health Authorities:
· Interlocutor of the local Health Authority
· Supports the manufacturing site understanding industrial constraints
Contribution to the development of a CEPiA Sales Regulatory Affairs network:
· Takes part of the regulatory network including the platforms (US, Japan, China, Russia, Latin America, India) sharing innovation initiatives, continuous improvement and best practices exchange.
· Maintains a personal good level of RA knowledge with adequate training. Takes part of training sessions for CEPIA team.
Assures Regulatory Intelligence:
· Follows evolution of the Regulation in CEPiA China Zone and inform RA CEPiA Corporate.

赛诺菲集团
赛诺菲集团是一家全球领先的多元化医药健康企业，专注于患者需求，传播健康。
 全球100,000余名员工，业务遍及100个国家
 新兴市场实力均衡，表现强劲，位列***
 多元领域，覆盖处方药、健康药业产品、疫苗和动物保健品
 疫苗领域的领导者
 领先动物保健市场
 2011年集团净销售额达334亿欧元

赛诺菲在中国
赛诺菲是首批在中国开设办事处的跨国制药集团，也是国内增长最快的医药健康企业之一。目前，赛诺菲在中国200多个城市拥有6000余名员工。
   
传承悠久历史、持续开拓进取
赛诺菲一直以来秉承对中国的承诺。1982年，赛诺菲成为首批在中国开设办事处的跨国制药企业之一。今天，赛诺菲已跻身中国医药健康市场的领军企业。赛诺菲的中国总部位于上海，并在北京、天津、沈阳、济南、上海、杭州、南京、武汉、成都、广州和乌鲁木齐共设11家区域办公室。

独特的医药健康产品系列、满足中国公共卫生需求
从预防到治疗，赛诺菲全方位满足中国的公共健康需求。集团的疫苗事业部赛诺菲巴斯德是中国领先的疫苗企业。赛诺菲在心血管/血栓、糖尿病、肿瘤、内科和中枢神经系统等关键的治疗领域拥有领先产品。2010年，杭州赛诺菲民生健康药业有限公司的成立标志着赛诺菲进入中国的非处方药市场。2011年2月，赛诺菲完成了对BMP太阳石的收购。

大幅投资工业建设、满足中国市场需求
赛诺菲目前在中国拥有六家生产基地，包括北京制药工厂、杭州制药工厂、杭州赛诺菲民生健康药业工厂、南昌梅里亚动物保健工厂、深圳赛诺菲巴斯德疫苗工厂、以及唐山健康药业工厂。

完善的研发架构、双赢的研发合作模式
在中国，赛诺菲具有从药物靶点发现到后期临床研究的整体研发实力。集团在上海设有中国研发中心和亚太研发中心，并在北京和成都分别设有研发机构。自2008年以来，赛诺菲与中国权威科研机构开展了10多项战略合作，在癌症、干细胞、糖尿病和老年疾病等前沿研究领域探索创新药物

依托于强劲的研发能力和多领域领先水平的广泛的医药产品资源，公司在中国的市场份额不断攀升，公司规模不断扩大，飞速发展的业务给了我们与更多优秀人才合作的机会。

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