【工作职责】
一、药政事务相关工作。Main job 1: Related work on Regulatory Affairs
1. 注册策略：负责项目全球CMC注册策略制定。负责代表注册参与本组品种的立项评估，参与产品TPP、CDP 制定，负责RSDP制定。为产品开发及注册提供方向和策略性支持，策划、组织关键时间节点与药品监管机构沟通。Registration strategy: Responsible for the development of global CMC registration strategy. Responsible for participating in the project evaluation of this group of varieties on behalf of registration, participating in the formulation of TPP and CDP products, and responsible for the formulation of RSDP. Provide direction and strategic support for product development and registration, plan and organize key time points to communicate with drug regulatory authorities.
2. 负责重点项目CMC注册相关工作，支持全球注册申报。Responsible for CMC registration related work of key projects, and support global registration declaration.
3. 项目CMC申报资料质量把关：负责对项目的研发方案和报告、与监管机构沟通交流材料以及申报资料的审核，确保符合法规要求。Quality control of project CMC application materials: responsible for the review of the project's research and development plan and report, communication materials with regulators and application materials, to ensure compliance with regulations.
4. 法规：提供注册咨询服务、法规解读、培训。Regulations: Provide registration consulting services, regulations interpretation, training.
5. 平台体系：负责药政CMC开发标准建立，技术平台、监管机构反馈等信息共享平台的建设和维护。Platform system: Responsible for the establishment of CMC development standards for pharmaceutical administration, the construction and maintenance of information sharing platforms such as technology platforms and regulatory feedback.
6. 公司指定的其他与职责相关的任务。Other tasks related to responsibilities assigned by the company.
二、团队建设和管理工作。Main job 2: Team building and management
负责团队建设，包括人才的选、育、用、留。Responsible for team building, including talent selection, education, use and retention.

【任职资格】
1. 学历及专业Education background and major：本科及以上学历，生物、药学相关专业。Bachelor degree or above, major in biology, pharmacy or related.
2. 资格证书Qualification certificate：英语六级证书Cet-6 certificate.
3. 专业知识Professional knowledge
1）精通国内注册法规和技术指导原则。Proficient in domestic registration regulations and technical guidelines.
2）精通CMC Regulation。Proficient in CMC Regulation.
4. 工作经验Work experience
1）本科10年、硕士5年及以上注册经验，了解生物药、化药、ADC的申报注册。Bachelor's degree of 10 years, master's degree of 5 years or above registration experience, understand the application and registration of biological drugs, chemical drugs, ADC.
2）至少3年团队管理经验。Minimum 3 years team management experience.
5. 技能要求Skill requirement
1）流利的英语表达、读写能力。Fluent in English, both written and written.
6. 其他要求Other requirements
优秀的组织沟通和协调能力。Excellent organizational communication and coordination skills.