招聘人数:1-2人
到岗时间:不限
年龄要求:不限
婚况要求:婚姻状况
1. Registration of products in China, US, UK, Japan and another country.
2. Assist with preparing and submitting product applications
3. Work with regulatory authorities in another country (as required)
4. Build the regulatory infrastructure, SOP documentation methods and forms for new standard.
5. Review and contribute to regulatory strategy documents
6. Assist with planning and preparation of market applications in CTD format
7. Provide training about regulatory to all employee
8. Maintain current regulatory affairs and technical knowledge through review of FDA website, trade newsletters, scientific publications, etc.
9. Facilitates the effective processing of quality system documents to ensure they are maintained and archived in an organized and retrievable state (manual or electronic) for accountability and access for any regulatory body.
10. Establishes and maintains library of product and process-related reference standards, regulations, guidance’s, clinical articles and journals.
11. Strongly required of working in function of changing regulatory environment (e.g. changes in legislation, changes in procedures), business objectives (prioritizing of dossiers).
12. Establish the technical file
13. In charge of Pharmaceutical validation, Quality control and release product
14. Manage and monitor the ISO 15378, 14001 and ISO 18001 management system
15. Report the FDA’ advisory notice
16. Conduct internal and supplier audit according to audit program
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