About the job
Core
Overseas Regulatory Affairs specialist responsible for writing CTD documents, managing regulatory submissions, and developing drug approval strategies for international markets.
Role type
Senior Regulatory Affairs Specialist (Overseas)
Builds
Regulatory submissions (IND, NDA, variations) for pharmaceutical products
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
CTD writing, regulatory submission management, drug approval strategy, IND/NDA experience, variation management
Preferred skills
Patch drug approval experience, business-level English communication
Technologies
CTD, IND, NDA
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