- 工作地点：北京
- 职位：Drug Regulatory Affairs Specialist (Job ID Gx 016)
- 信息来源：中华英才网
说明：
Major Accountabilities: 此信息由中华英才网审核并发布（查看原发布网址），应届生求职网转载该信息只是出于传递更多就业招聘信息，促进大学生就业的目的。如您对此转载信息有疑义，请与原信息发布者中华英才网核实，并请同时联系本站处理该转载信息。
Initiate dossier preparation, request available regulatory documents from HQ and within Sandoz China (Scientific Affair, Clinical Affair, and Tech Op); Initiate and confirm translation of dossiers for all documents; to translate key technical documents on the registration dossiers; to reviser and write summary and other documents to make them meet requires of Chinese Regulation
Coordinate the patent search and confirm the administration and new drug protection in China
Ensure registration documentation, samples submission and process to related government department
Be the key players in clearance and review of all promotional materials to ensure legitimacy of the materials.
To be a specialist of Chinese drug regulatory and provide update information on regulatory requirements of SFDA
To build relationships with officers and departments of SFDA to ensure approval procedure within set timelines
To be a good coordinator for 3rd researching company and a good project member
Education :
Minimum: University degree in the life sciences (medicine, Pharmacy, bio-sciences)
Desirable: A graduate degree in Pharmaceutics or Medicine
Experience:
Board multi-functional experience in pharmaceutical development process and science, specifically in regulatory, clinical or chemistry
Languages:
Oral and written communication in English
谁把握机遇，谁就心想事成。 -- 歌德 .www.yingjiesheng.com@.
