Regulatory Affairs Specialist (NMPA)

📋 Description

• Act as RA lead for China product registrations (RA Lead/PM)
• Coordinate regulatory/clinical strategy and timelines for NMPA submissions
• Manage registration trackers and the China Regulatory Project Executive Summary
• Support cross-functional teams, audits, and China localization projects

🎯 Requirements

• Hybrid onsite weekly in Sunnyvale, CA
• Mandarin Chinese required
• 3+ years RA experience
• 1+ year NMPA regulatory experience (China GB/YY and US FDA)
• Education: BS/BE in life science; advanced degree preferred
• Cross-functional collaboration and strong project management skills