Sr. Regulatory Affairs
Core
Manage registration of imported drugs with Chinese authorities (NMPA, CDE), handling document preparation, testing, submission, and approval follow-up.
Role type
Senior Regulatory Affairs Specialist (Imported Drugs)
Builds
Regulatory approvals for imported pharmaceutical products in China
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
Drug registration lifecycle management, regulatory document preparation, authority communication, data archiving
Preferred skills
Medical education background, experience with API/ANDA/IND registrations, English proficiency
Technologies
N/A
Responsibilities
Communicate with NMPA and CDE regarding imported drug registrations, prepare and submit registration documents, coordinate testing and follow up until approval, archive regulatory documents
Seniority
Mid-level, hands-on IC