Regulatory Affairs Specialist - Supporting China Product Registration

📋 Description

• Partner with in-country RA, Product Localization Engineering, and cross-functional teams
• Ensure regulatory compliance for China market across product lifecycle
• Maintain regulatory filings and licenses; support pre/post-market activities
• Coordinate with China authorities for registrations and submissions
• Contribute to regulatory intelligence and process improvements
• Adapt plans as priorities evolve

🎯 Requirements

• BS/BA in life sciences or related field; advanced degree preferred
• Minimum 6 years RA experience; 4+ years international submissions
• Knowledge of NMPA requirements, GB/YY standards, US FDA basics
• Experience with complex product development and RIMS (e.g., Veeva, Rimsys)
• Strong written/verbal communication; cross-functional teamwork
• Project management experience; Chinese language a plus

🎁 Benefits

• Competitive compensation; base pay and incentives
• Equal opportunity employer; diverse and inclusive
• Vaccination details may vary by role