岗位职责：
1.Manages the dossier preparation process from initiation through to approval for major Regulatory submissions (IND, NDA, Agency Responses, others). Leading initialtives from dossier planning and R M&O perspective, as well as esblish related functional processes 管理主要注册提交资料（IND, NDA, 发补回复等）准备从开始到批准提交的全部流程；从档案规划和R M&O 角度出发，引领相关工作和建立相关流程。
2.Creates target document translation/proof reading timelines, and follow up and manage the vendors/contributors to finish the tasks in a timely manner.创建目标资料翻译/校对的时间表，跟踪和管理翻译供应商、参与校对者及时完成相应的任务；
3.Download the target original documents according to the TOC from RA colleagues, and assign the vendors for Chinese translation;按照注册项目负责人提供的资料目录下载目标原始文件，并指定翻译供应商翻译中文；
4.Create the dossier binder in Veeve-Vault, and combine the original documents with binder according to TOC; 在Veeva-Vault中创建提交文件夹，并按资料目录将目标原始文件绑定到文件夹中；
5.Interface with the vendors to ensure the translation/proofreading quality, format and time, and collect the pieces in a rolling manner; 与翻译供应商沟通协调以保证翻译/校对质量、格式要求和时间，并滚动回收已完成的文件；
6.Assign the team members for proof reading of the translated documents and RO member for format and QC check, and document ready process; 将回收的翻译文件分发给专业团队成员进行校对，之后指定R M&O 成员进行格式和一致性检查， 最后进行文档审批流程；
7.Coordinate with regulatory, clinical, non clinical, CMC and other key members to resolve various submission issues; identify solutions and best practices from dossier planning and R M&O perfessional. 与注册项目负责人、临床、非临床、CMC以及其他重要参与者协调解决资料准备中遇到的各种问题；从文档规划和 R M&O 专业经验，识别决绝档案和总结最佳实践
8.Update the dossier preparation status to submission team/RA strategist in a timely manner; Communicate impacts and risks, and actively promote the achievement of objectives. 及时向提交团队和注册策略负责人更新资料准备进展，传达影响和风险，并积极推动目标完成。
9.Collect the updated regulatory requirements related to document format and submission process, and share with the submission team in a timely manner;及时收集有关资料格式要求和提交流程等最新法规信息，并分享给提交团队；
资历要求：