北京招聘

This role should：

• Be responsible for the regulatory SoP/guidance development, update, maintenance and related training. To streamline working procedure with the internal and cross-functional departments in order to achieve the work efficiency and effectiveness. Ensure the regulatory compliance with the Good Regulatory Practice as well as to meet global and local regulatory requirements.
• Understand company’s compliances policy, and to manage the daily team activity to align with these accordingly.

  Summary of the Job’s main purpose:

• Work closely with global functional team and local related functional team to understand the policies, guidelines and SOPs;
• Be accountable for coordinating China RA guidance and SOP development and update, being responsible for guidance and SOP maintenance;
• Facilitate the process improvement in regulatory team and cross-functional;
• Be accountable for the preparation of the local regulatory Affairs team for self-audit/audits/inspections;
• Provide and facilitate the timely training to local Regulatory Affairs team on policy, guidance and SOPs to ensure the compliance; and other technical training programs to improve the competence on regulatory skills;
• Work with global functional team as well as local team to identify and design the training programs to enhance regulatory competence of the local team
• Being responsible for orientation programs for local new staffs;

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。