DRA Specialist

汇报对象: Senior DRA Manager




-Initiate dossier preparation, request available regulatory documents from HQ and within Sandoz China (Scientific Affair, Clinical Affair, and Tech Op)
- Coordinate the patent search and confirm the administration and new drug protection in China
-Review registration dossiers, to ensure registration documentation to confirm the requires of SFDA
-Initiate and confirm translation of dossiers for all documents received into Mandarin (or into English) through project team review
- 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
-To translate key technical documents on the registration dossiers


-Education : Minimum: University degree in the life sciences (medicine, Pharmacy, bio-sciences), a graduate degree in Pharmaceutics or Medicine
-Languages: Oral and written communication in English
-Board multi-functional experience in pharmaceutical development process and science, specifically in regulatory, clinical or chemistry
- Competency: Priority setting; Drive for results; Ethics and values; Process management; Problem solving; Functional technical skills



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