职位描述
- Participate in local project relevant teams and meetings as needed for China development project discussion and update
- Work closely with T.C.M. Medicine relevant functions (e.g., LRA, TAs, Clinical Dev & Ops, PPM) in ensuring the timely and quality submissions
- Fully understand the plan, progress, and status of the pipeline development projects in China and reflect the information properly to global CMC Experts NCE primarily and relevant functions
- Work with global CMC Experts NCE primarily in providing necessary support during dossier preparation (e.g., consultation, drafting, review), esp. for China specific documents
- Provide technical input or leverage expertise within Global NCE Development related to CMC topics specific to China
- Provide technical input or evaluation for internal regulatory intelligence network (RIN) regarding CMC CN specific law/guideline/industry position/official publication and announcement as needed
- Monitor,translate, and communicate strategic changes related to CMC development in China to key stakeholders in Global NCE CMC Experts primarily
- Support RA/CMC RA in preparation of submissions in China and in meetings with the authorities by providing scientific input and support in personal and through the relevant experts in the global network
- Contribute to interactions with Chinese regulatory agencies and institutions (e.g NMPA/CDE/NIFDC/Chinese Pharmacopeia/RDPAC) as needed, by working with relevant China functions and global functions
以担保或任何理由索取财物，扣押证照，均涉嫌违法，请提高警惕