position overview
Position: Regulatory Affairs Project Manager/ 法规事务项目经理
Job Location : China 中国办事处： 上海，北京
Job Type: Permanent Full-time ( remote)
We are searching for an experienced for a Regulatory Affairs Project Manager at our office in China. The successful candidate should have strong regulatory and management skills, have worked and interacted with CFDA on many occasions and have experience registering a variety of products including drugs and medical devices in China. The RA Project Manager will be responsible for managing the timelines and track the progress of regulatory submissions as well as communicate efficiently between the RA team and clients.
GRP中国办公室诚招一位有经验的法规事务项目经理。成功的候选人应具备较强的监管和管理技能，曾多次与 CFDA 工作和互动，并具有在中国注册包括药品和医疗器械在内的多种产品的经验。RA 项目经理将负责管理时间表和跟踪监管提交进度，以及在 RA 团队和客户之间进行有效沟通。
RESPONSIBILITIES:
- Preparation and writing of documents needed for submission.
- Translate necessary documents
- Submit necessary files and applications for respective HA
- Formatting, Hyperlinking and converting documents to PDF’s
- Research on Chinese regulation and communicating them to GRP.
- Applying knowledge of electronic publishing requirements to ensure compliance with agency submission requirements
- Remaining current with evolving standards for electronic submissions
- Keeping abreast of regulatory procedures and changes.
- Performing quality control checks for submission ready documents.
- Participating in regulatory-clinical cross functional team meetings and project teams.
- Tracking of regulatory projects and submissions.
- Meeting the timelines of regulatory submissions.
- Performing regulatory intelligence and research on different projects.
- Assisting RA manager in the finalization of the regulatory submission.
岗位职责：
- 领导、管理和激励多学科远程团队
- 管理供应商谈判、选择和质量
- 管理各种设施的网络基础设施
- 创建和管理业务系统
- 回答问题并处理出现的问题
- 评估和确定项目资源需求
- 利用项目管理工具来计划、跟踪、确定优先级并将时间表和可交付成果传达给项目团队和 客户
- 考虑对资源和收入预测的影响，积极管理时间表
- 评估项目质量和风险
- 管理合同研究，包括在必要时主动管理预算、转嫁成本和合同修订
- 确保遵守 SOP 和NMPA其他相关法规
- 保持积极的、以结果为导向的工作环境，建立伙伴关系和团队合作模式，
- 主动与客户沟通，提供定期和及时的更新
- 定期向客户寻求反馈
- 主动有效地管理和沟通问题及解决方案
- 确保对所有客户的询问和沟通做出充分和及时的回应
- 了解并欣赏客户的业务需求
- 能够将复杂的技术、医学和/或需求描述翻译成客户可以理解的语言，以帮助他们做出决策及有效地理解项目
REQUIRED QUALIFICATIONS
- Requirements include a B.A./B.S. degree in the Life Sciences or a related field, and self-starting ability with excellent written and verbal communication skills.
- At least 2 to 3 years’ experience in preparing regulatory submissions, publishing and in documents management in pharma or biotech industry.
- Proficiency in MS Word, MS Excel, and Adobe Acrobat is essential.
- Experience using electronic submission software is a definite plus, as is proficiency in preparing documents that are compliant with electronic submission standards.
- Familiarity with Microsoft Access and SharePoint is preferred.
- Understanding of the drug development process.
- Working knowledge of industry legislation and best practices
- Document management, or equivalent technical experience.
- Project management.
- Ability to work in a fast-paced environment that is primarily timeline-driven.
- Ability to manipulate large and complex documents required for submissions.
- Attention to detail with the ability to multi-task.
任职要求：
- 优秀的人际交往、口头和书面沟通技巧
- 优秀的英语和普通话书面和口语能力
- 以客户为中心的工作方法
- 具备自我启动能力，能够自主工作和作为团队的一部分工作
- 具备良好的问题解决能力、学习能力、项目管理能力
- 拥有对工作分配和新学习的灵活态度
- 能够满怀热情地管理多项不同的任务，并在关注细节的情况下优先考虑工作量
- 愿意在矩阵环境中工作并重视团队合作的重要性。
GENERAL REQUIREMENTS:
- Minimum Experience Level: 3-year
- Career Level: Mid-Career
- Minimum English Level: Daily Conversation
- Minimum Mandarin Level: Native
- Minimum Education Level: Bachelor’s Degree
- Visa Status: Permission to work in China required
- Age Limit: No Age limit for applicants
工作环境：
- 工作类型：永久全职
- 可以远程或现场工作
- 薪资： 根据经验面议
INFORMATION ON GRP
- Company type: International CRO
- Company Headquarters: USA
- Office Locations : China; Shanghai and Beijing ( 上海、北京)
公司信息：
- 公司类型：国际CRO
- 公司总部：美国
- 中国办事处： 上海，北京