南平招聘

[Responsibilities]
-Develop effective and systematic approaches to bring functional excellence to Regulatory Policy across the Sanofi group in Asia/China with emphasis on key markets. Drive best practices and excellence in execution within the department and cross-functionally.
-Oversee the creation, standardization and implementation of systems/processes to monitor the regulatory environment for changes, and to work with subject matter experts within the company to assess impact on Sanofi’s products and goals (eg. China 2030 roadmap).
-Develop and implement regulatory policy strategies based on regulatory and legislative trends important to Sanofi’s strategy, product portfolio and therapeutic areas.
-Monitor, identify and assess regulatory policy or policy in its formative stages for relevance and impact to company’s internal processes, drug development and or regulatory and corporate strategies. Effectively communicate impact and bring awareness of business critical issues for informed decision making.
-Define in collaboration with the Head of Regulatory Science and Policy, Aisa/China and other internal and external stakeholders those areas of policy interest for Sanofi, and industry at large, that would benefit from clear industry positioning. Provide subject matter expertise on emerging regulatory issues and how the Sanofi group can engage to influence policy outcomes.
-Organize and facilitate interfaces to propose draft Policy for such identified areas and collaboratively within Sanofi, and external stakeholders as appropriate, prioritize and route it for review and approval through the corresponding governance/clearance process. Routinely communicate and coordinate regulatory policy activities and work products.
-Bring and advocate Sanofi’s agreed policy positions to those bodies and thought leaders that bear influence in translating it into action (i.e., implement regulatory change and evolution).
-Work closely and partner with a number of subject matter experts to plan regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key topics of interest (influence regulatory authorities in the development and implementation of emerging regulatory policy).
-Drive effective and efficient collaboratively support to internal Sanofi groups, functions and/or cross-functional teams. Provide leadership and guidance on Policy matters. Strategize and present action plan to address/mitigate future issues.
-Work with internal staff and outside consultants, as appropriate, to compile a comprehensive picture of regulatory policy in individual countries and regions, including analyses of issues and their impact on the company’s product portfolio.
-Support regulatory interactions on policy and advocacy issues, including building relationships with key regulatory decision makers. Provide guidance for company relationships with other regulators and decision makers to further expand these relationships.
-Proactively participate and track key developments from health authorities, trade associations, special interest groups, industry thought leaders and other external parties that are relevant to regulatory activities at Sanofi and industry at large. Communicate regarding specific regulatory trends, analysis, policies and intelligence to different functions. Guide the strategy to understand and mitigate impact.
-Serve as key liaison, and represent Sanofi as assigned, with trade associations, think tanks, advocacy organizations and regulatory authorities, managing and guiding the strategy for and execution of these interactions.
-Lead routine and ad hoc meetings within function and cross-functionally.
-Liaise closely with colleagues (R&D, External Affairs, etc.) leading policy activities in the external environment to ensure regulatory insights and overall alignment on Sanofi position.
-Conduct ongoing healthcare analyses/forecasting, which requires in-depth knowledge of legislative/regulatory environment.
-Identify issues that will impact the business now and in the near future with a view to predicting trend. Work collaboratively with other policy/intelligence groups to optimize horizon scanning.
-Advance regulatory science by contributing to the ideation and development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated products.
-Write, coordinate and/or review commenting on regulatory or legislative initiatives and guidances as appropriate and assigned.
-Produce regulatory intelligence reports or deliverables as it relates to project or process strategies to further regulatory strategy and decision-making. Prepare and deliver regulatory intelligence alerts, summaries, reports and newsletters on regular schedule highlighting pertinent regulatory activities and potential impact on Sanofi products and businesses.
-Conduct the initial analysis of commenting opportunities and assist with drafting of comments for submission to industry organizations, Health Authorities and other stakeholders.
-Work with external parties/consultants as appropriate to define messaging approach and strategy.
-Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may bear influence to Sanofi and propose action plan.
-Ensure a current view and perspective of internal/external influences and or implication’s to Sanofi’s therapeutic areas and development projects. Work in collaboration with other functional leaders in Regulatory on regulatory policy issues that affect the portfolio. Collaborate closely with Government Affairs and other key stakeholders within Sanofi on the development and implementation of regulatory policy goals.
-Monitor and interpret the environment: strategically monitor/search the external environment in line with divisions, franchises and geographies and bring emerging issues forward for consideration.
-Analyze and apply relevant intelligence findings in the context of current Sanofi business and project activities. Promote a regulatory intelligence culture that supports a targeted approach to regulations: gather, collect and collate regulatory information that can be used to inform of risks, develop initiatives, identify emerging regulatory issues in R&D, quality, compliance, business, etc.
-Maintain consistent oversight of deliverables and ensure issues are escalated when needed and encourage resolution at the appropriate level.
-Play a key role in development and implementation of appropriate systems, processes and standards within Regulatory Science and Policy and within GRA and Sanofi as assigned.
-Keep all internal customers, partners and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives.
-Act as a member of committees and task forces, etc. as assigned.
-Act consistently with Sanofi best practices and code of ethics
[
职位要求：
Experience and skills]
-Advance life science degree.
-+10 years’ experience in the field and/or related areas. Extensive and proven expertise in Regulatory environment in healthcare.
-Significant understanding of the drug/biologic development and commercialization process.
-Previous experience working with senior-level members or officials of trade associations or other key groups that influence regional policies.
-Existing relationship with local/regional government legislators, committees, administrative staff or other key parties or influencers.
-In-depth familiarity with competitive activity in the field.
-Experience in participating in, or supporting, global product development or other cross-functional teams.
-Impeccable ethics and proven ability to demonstrate Sanofi values.
-Proven leadership skills. Self-motivated, prone to action and results oriented. Provides an engaging and motivating work environment.
-Ability to lead multiple complex initiatives (short, mid and long-term). Superior time management and organizational skills.
-Excellent business acumen and strategic agility. Critical thinker. Good judgment and decision making abilities.
-Outstanding interpersonal and communication/presentation skills.
-Strong influencing and negotiation skills.

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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