DRA Specialist

汇报对象: Senior DRA Manager

工作地点:

北京

主要工作职责:

-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

职位要求:

-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

联系方式:

地址:上海市淮海中路1045号淮海国际广场8层(请注明应聘职位)
邮编:200031
E-mail:referral.hr@sandoz.com

返回 >

 

Select a category

Related content

Website update - Join us

关注我们

你可以在LinkedIn(领英)找到山德士主页,实时关注我们的最新动态。 了解更多