客户公司介绍：
这是一家提供全面服务的临床前和临床眼科药物和设备开发公司。公司拥有一支致力于将眼科创新推向市场的全球化团队，以深厚的眼科专业知识而闻名。公司拥有经过验证的临床前和临床模型、强大的研发技术平台、以及大量项目的临床注册方案。公司遵循着以客户服务、领导力、高度责任感、结果导向、创新、团队合作和客户为先的价值观，为客户提供全方位的服务！
Client's company profile:
THIS is a full-service pre-clinical and clinical ophthalmic drug and device development firm. We’re known for our deeply rooted ophthalmology expertise, with a global team dedicated to bringing ophthalmic innovations to market. We provide proven pre-clinical and clinical models, powerful technology-based methods, and regulatory strategies across a broad variety of projects. We offer a comprehensive range of services characterized by our values of customer service, leadership, accountability, results, innovation, teamwork and you!
招聘岗位：
高级注册经理
Senior manager regulatory
工作职责：
计划、编写和跟踪国家药品监督管理局法规申请和提交的编写和汇编，包括一般信函、INDs（新药临床试验申请）、HGRAC（国家人类遗传资源管理）、临床方案和信息修订、年度报告、安全报告、会议简报文件以及NDAs（新药上市申请）/ MAA（新药上市许可申请）。
根据申办者的目标制定提交计划和时间表，负责审查项目时间表，里程碑计划并跟踪。
审查和执行临床和申报资料的质量控制检查，重点是拼写、语法和公司或特定于申办者的样式约定。
审查并协助向外部监管机构发布和提交文件。
对其他发布者生成的文档执行质量控制检查，以确保所有提交的文档均符合公司的电子提交就绪PDF标准。
审查并为申报资料的汇编和电子文档提供支持，以支持所有必需的文件系统。
负责协调法规团队的质量控制和提交时间表。
协助审查和修订程序、规范、模板和表格。
审查硬拷贝和电子文档的规范归档系统。
执行跟踪文档的数据输入。
更新跟踪日志、数据库和法规文件目录。
视需要并在时间允许的情况下协助撰写申报资料。
根据业务的特定需求，职责可能与上述职责略有不同。
清晰、持续地展示公司的客户服务、领导力、高度责任感、结果导向、创新和团队合作的价值观。
Responsibilities：
- Plan, author, and oversee the authoring and compilation of NMPA regulatory applications and submissions, inclusive of general correspondence, INDs, HGRAC, protocol and information amendments, annual reports, Safety reports, meeting briefing documents, and NDAs/MAAs.
- Develop submission plans and timelines in accordance with Sponsor goals, responsible for overseeing project timelines and the planning of regulatory milestones and tracking of commitments.
- Oversees and performs quality control checks on clinical and regulatory documents, focusing on spelling, grammar, and company or sponsor-specific style conventions.
- Oversees and contributes to publishing and submission of documents to external regulatory authorities.
- Performs quality control checks on documents that are generated by other publishers to ensure all submission documents meet company's e-submission-ready PDF standards.
- Oversees and contributes to compilation of regulatory filing documents and maintaining computerized files to support all required documentation systems.
- Responsible for coordinating the QC and submission schedules for the Regulatory team.
- Contributes to the review and revision of procedures, specifications, templates, and forms.
- Oversees the organized filing systems for hard-copy and electronic documents.
- Performs data entry for tracking documents.
- Updates tracking logs, databases, and catalogues of regulatory documents.
- Contributes to the writing of regulatory documents as needed, and as time permits.
- Responsibilities may differ slightly from the above based on specific needs of the business.
- Clear and sustained demonstration of the company’s Values of Customer Service, Leadership, Accountability, Results Oriented, Innovation and Teamwork.
任职要求：
应用或生命科学或传媒学学士学位。
在治疗和医疗设备方面具有4-5年的法规经验（最好有眼科产品相关法规经验）或同等的培训和工作经验。
熟悉中国大陆的法规环境和要求。
具有eCTD格式的经验。
具备双语能力（普通话和英语），并具有流利的英语阅读，写作和口语能力。
熟练掌握Microsoft Office等办公软件（尤其是Word）。
具有在团队环境中良好工作的能力，对完成任务具有高度责任感，可以遵循流程，主动发现改善机会并通过人际关系促进和完成对问题的建设性解决方案。
能够在快节奏的环境中工作。
注重细节，注重准确性和质量。
能够对工作进行优先排序，以平衡多个项目和截止日期。
优秀的口头和书面沟通技巧。
具备生成和使用指南和模板的经验。
熟悉临床试验流程和注册申报事务。
有电子出版经验，熟悉Adobe Acrobat优先。
具有全球团队合作经验并具有根据时区差异灵活工作时间的能力优先考虑。
Abilities:
- Bachelor's degree with at least 2 years’ experience as a Clinical Research Associate. Years of experience may be considered in lieu of education.
- Past ophthalmic experience is preferred.
- Capacity to routinely assess protocol and GCP compliance.
- Demonstrated ability to verify source data to reported data.
- Strong attention to detail in order to review completeness of the investigator site file. Knowledge to reconcile and return/destroy test article while conducting initiation, interim, and close-out visits.
- Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
- Ability to read and demonstrate a comprehension of a clinical research protocol as well as understand the importance of following the protocol.
- Proficiency with Excel, CTMS and EDC.
- Bilingual capability (Mandarin and English) with professional fluency in reading, writing, and speaking in English.
- Experience working with a Global team is preferred with an ability to work flexible hours based on the time zone differences.
工作地点：可灵活安排，北京（优先考虑）
Job Location：Flexible，Beijing is preferred
薪资：面议
Salary in negotiable
如果您对我们的工作感兴趣，欢迎投递简历至：
zengjin@vvrinternational.com