北京招聘

This position is responsible for the capturing, distribution, assessment and advocacy of the regulatory policy/regulations for Greater China Region (China mainland, HK, TW).

• Monitor regulatory environment and providing policy impact analysis and strategic access plan.

  Timely and proactively collect regulatory regulations, coordinate RA internal assessment and feedback to the HA or the relative association. Keep effective communication with external/internal partners, and timely providing regulatory policy position paper and briefing aligned with RALT. Develop and execute the policy shaping and advocacy strategy and plan which are aligned with RALT and AZ position. Utilize the varied platforms to enable the HA engagement programs.

• Role as regulatory policy expert to provide the training and interpretation internally and externally.
• Be the company/RA representative in the assigned WG or TF of the industry association to cooperate for the policy/regulatory assessment and advocacy Work closely with industry associations, Chamber of Commerce, working groups, International Exchange Center, Standard Committee, etc., participating and coordinating the relevant meetings and events.
• Develop the RP process or system and continuing improvement regulatory strategy:
• Deeply understand the policy & regulatory changes, anchor the strategy & impact analysis to business and new projects
• Support RA Head and RA LT on the assigned regulatory policy & RA strategy related projects

  JOB RESPONSIBILITIES

  Indicate the primary responsibilities critical to the job.

• Adherence to Pfizer Upjohn and industry code of conduct, ethics and good regulatory practices including RA SOPs and other required SOPs.
  • Align with the values and vision of Pfizer Upjohn
  • Maintain regulatory compliance with Local legislation, Global regulatory policies
  • Maintain company confidentiality (i.e. intellectual property, product information and strategic information)
  • Follow SOP requirements especially on documentation
• Monitor regulatory environment and providing policy impact analysis and strategic access plan
  • Establish/maintain the process/database for the intelligence collection
  • Arrange the regulatory intelligence/policy assessment meeting and take the meeting minutes
  • Coordinate the consultation with external parties if any for the policy assessment
  • Draft the assessment report based on the discussion internally and the consultation with the external party if any
  • Coordinate the review to report and share with the key stakeholders in a regular basis.
• Keep effective communication with external/internal partners
  • Effective internal cross-functional communication within key stakeholders for identifying technical topics.
  • Timely providing regulatory policy position paper and briefing
• Timely collect authority regulatory regulations, coordinating RA internal discussion and feedback to relative department.
• Work closely with industry associations, Chamber of Commerce, working groups, International Exchange Center, Standard Committee, etc., participating and coordinating the relevant meetings and events.
• Exert external influence to shape the environment.
• Contribute on BD projects to deliver the regulatory strategy, assessment and timeline

在辉瑞，我们致力于运用科学以及我们的全球资源来改善每个生命阶段的健康状况。在药品的探索、开发和生产过程中，我们致力于设定品质、安全和价值标准。我们多样化的全球医药产品包括生物药品、小分子药品和疫苗，以及许多世界驰名的消费产品。每天，世界各地的辉瑞员工致力于寻找我们这个时代最为棘手的疾病的预防和治疗方案。辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可负担的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。

为了践行上述诺言，辉瑞创建了新的业务机构-辉瑞Upjohn. 辉瑞Upjohn 兼具创业公司的敏捷性、以及全球财富百强企业的资源和能力。因此，我们在创新与快速执行方面拥有独特的优势，包括激活我们的研发产品线、提高生产效能，以及快速推进产品研发等方面。

在辉瑞 Upjohn，我们相信，建立审慎的合作伙伴关系和开展协同合作，对创建可持续的医疗卫生解决方案至关重要。我们热切希望成为非传染性疾病(NCD)防治领域的***合作伙伴。由于中国市场与日俱增的重要性和机遇，同时为了确保我们能有效制定正对当地需求的健康解决方案 - 辉瑞 Upjohn高层管理团队的一些重要成员(每位都有20多年行业经验)和大部分部门都将在中国工作。这将使辉瑞 Upjohn真正实现本地化，并具备必要的速度和灵活性，从而在保持同辉瑞相关组织强有力联系的同时，切实抓住各种增长机遇。