Summary
About the Role
~ 协调并为指定产品编制高质量的监管文件以供提交
~ 在指定日期完成CTA/NDA提交；
~ 在指定日期获得CTA、NDA和其他相关补充申请的批准；
~ 确保按时提交和批准许可证续签；
~ 确保CMC/BPI/PSUR/RMP符合NMPA法规和Novartis内部政策；
~ 确保注册主文件更新
~ 协助协调与CFDA / CDE进行面对面会议，以讨论新项目
~ 及时顺利传达卫生局提出的问题；
~ 及时更新注册状态并将其传达给部门经理
~ 及时预订并跟踪注册样本、档案、证书…；
~ 开始与主要利益相关方建立良好的沟通和关系。
~ 熟悉公司和部门标准操作程序（SOP）和工作程序
~ 在收到诺华产品后24小时内报告与诺华产品相关的技术投诉/不良事件/特殊情况
~ 营销样本的分发（如适用）
Key Performance Indicators
~按时、按质完成指定任务。
~遵守法规和内部程序
~ Relevant databases and archives up~to~date.
Work Experience
~运营管理和执行
~项目管理
~职能广度
~跨文化经历
Skills
~数据库
~项目规划
~临床试验
~协作
~生命科学
~注重细节
~法规遵从性
Language
英语
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
