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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.
Read our handbook (PDF 30 MB)
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 diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
