商丘招聘

Mission:
The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Affiliate Regulatory Groups, Technical and Quality Groups within R&D and Industrial Affairs, External Alliance Partners, Project Direction/Management, Human Resources, Legal, Finance, Regulatory Health Authorities, Others. The incumbent is also engaged in internal and external Regulatory Policy Organizations/Programs in order to develop and maintain appropriate Sanofi representation in these activities. The incumbent demonstrates behaviors that live and promote the Sanofi and GRA Values/Principles/Competencies.
Duties & Responsibilities
Develops global (if needed) and China regulatory CMC strategies and risk assessments for development biological projects and major activities on marketed products in collaboration with Global GRA CMC and regional GRA functions. Assures that positive and collaborative relationships are developed with local CMC teams (CDDC, iCMC PM, IA, QA)to achieve the implementation of appropriate regulatory strategies. Assures that, for major CMC activities for CTA, NDA, post approval change, license renewal, new product launch preparationetc. that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.
Assures appropriate contacts with Health Authorities (e.g. NMPA, CDE, NIFDC, CFDI, ChPC, etc.) are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships with Health Authorities. Supports strategic negotiations with Regulatory Health Authorities in other regions so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS).
Supports or directly contributes to the preparation, review and approval of regulatory CMC dossiers for submissions in China, in collaboration with GRA CMC&D, CDDC and China RA. Assures that submission dossiers meet appropriate quality standards
strategies and mitigated risks are developed and communicated, and deadlines are achieved. Assures that technical and regulatory CMC issues are appropriately resolved with optimal solutions.
Contributes knowledge and expertise on the GRA CMC&D China Focus Group, GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, e.g. the RDPAC CMC taskforces, in order to assure that appropriate Sanofi visibility and input is recognized. Monitors the review of local and international Health Authority regulations and guidelines, contributes to the commenting process and/or develops position papers. Assures that current Health Authority thinking and trends (paradigm shifts) are understood and broadly communicated.
Knowledge, Skills & Competencies / Language
-Global and China rich experience in Regulatory or Regulatory CMC and Devices or biologocal technical functions. Should demonstrate a high level of initiative, independent thinking, anticipatory foresight, and be able to communicate effectively to broad, sophisticated, formal/informal, internal and external audiences.
职位要求：
-Ability to facilitate alignment of expectations from the global program and (internal/external) stakeholders with local China needs and to propose smart ways forward
-Strategic thinking and creativity is required to match the local regulatory constraints and develop smart regulatory CMC strategies for China in line with the company strategy / objectives
-Ability to work self-contained in a matrix organization while keeping strong connection to management and stakeholders
Qualifications
-Minimum of advanced degree (Masters, PhD) in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.)
-Technical pharmaceutical CMC and/or Devices experience (in GMP laboratory or manufacturing, etc.) plus an additional 3-8 years of direct Regulatory CMC and/or Devices experience is desirable.
-Strong knowledge in China-FDA regulations and exposure to international regulations (US-FDA/EMA) is essential
-Experience working for a Regulatory Health Authority is a plus but not essential.
-Fluent Engish and Chinese is a must

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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