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Sr. Regulatory Affairs

Beijing, China💼 Full-time🗓 2026-03-17 → 2026-09-26

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

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