岗位职责: 1.负责协助委托方完成IND/CTA、NDA/BLA/MAA等全流程申报资料（模块1-5）的审核与提交，确保合规性。 Responsible for assisting the client in reviewing and submitting full-process regulatory filing documents (Modules 1-5) for IND/CTA, NDA/BLA/MAA, etc., ensuring compliance. 2.负责协助委托方管理产品上市后变更、补充申请及再注册工作。 Responsible for assisting the client in managing post-approval changes, supplemental applications, and marketing authorization renewals of products. 3.做为公司注册方面专家，参与客户之间的技术交流等活动，协助完成产品注册方面评估和风险把关。 As the company s regulatory affairs expert, participate in technical exchanges with clients and provide expert support for product registration assessments and risk evaluations. 4.协助委托方参与药监部门（如CDE、FDA等）的沟通会议。 Responsible for facilitating client participation in regulatory interactions with authorities (e.g., CDE, FDA), including pre-meeting briefings and strategy coordination. 5.协助公司技术团队和客户，识别研发及申报过程中的合规风险（如数据完整性、试验设计缺陷），提出解决方案并推动整改。 Responsible for assisting the company s technical teams and clients in detecting compliance risks (e.g., data integrity issues, clinical trial design deficiencies) during R&D and regulatory submissions, developing corrective actions, and driving remediation initiatives. 6.建立注册法规动态监控机制，定期更新国内外指南数据库，为公司后续的商务开展方向提供意见。 Responsible for establishing and maintaining a regulatory intelligence monitoring system, regularly updating global and local guideline databases, and providing strategic advisory for the company s business development direction. 7.参与整个项目交付过程，负责注册方面的风险识别和确保政策策略与项目进度一致。 Responsible for establishing and maintaining a regulatory intelligence monitoring system, regularly updating global and local guideline databases, and providing strategic advisory for the company s business development direction. 任职要求: 1、5年以上创新药注册经验，至少主导1-2个临床前至三期临床产品的国内外注册案例。 With more than 5 years of experience in innovative drug registration, and at least 1-2 cases of leading domestic and foreign registration of products from preclinical to phase III clinical trials. 2、熟悉中美双报流程，具备IND、NDA/BLA申报成功经验者优先。 Familiar with the processes of China-US dual filing, and those with successful experience in IND, NDA/BLA submissions will be given priority. 3、精通国内外注册法规（NMPA、FDA、ICH等）及技术指南，熟悉eCTD系统。 Proficient in domestic and foreign registration regulations (NMPA, FDA, ICH, etc.) and technical guidelines, familiar with the eCTD system. 4、优秀的英语读写及口语能力，可流利参与国际会议及沟通。 Excellent English reading, writing and speaking skills, able to fluently participate in international conferences and communications. 5、熟练使用项目管理工具，具备风险分析和决策能力。 Proficient in using project management tools, with risk analysis and decision-making abilities. 6、具有FDA/EU预沟通会议经验或注册咨询背景（如有，为佳）； With experience in FDA/EU pre-communication meetings or a background in regulatory consulting (preferred if available). 7、逻辑清晰，抗压性强，适应快节奏工作环境以及CDMO模式的工作方式； With clear logic and strong stress resistance, able to adapt to fast-paced work environments and CDMO model working style.