China Regulatory Affairs Specialist
Core
Prepare, compile, review, and submit regulatory documentation for product registrations, renewals, and lifecycle management in Hong Kong and Macau; support international market registrations and post-market surveillance.
Role type
Regulatory Affairs Specialist
Builds
Regulatory dossiers and submissions for product registrations and renewals in Hong Kong, Macau, and international markets
Domain
Healthcare/Pharmaceuticals Regulatory Affairs
Required skills
Regulatory documentation preparation, submission coordination, license maintenance, post-market surveillance support, stakeholder coordination, compliance monitoring
Preferred skills
International market registration support, regulatory impact evaluation, complaint handling, quality record maintenance
Technologies
Regulatory databases, quality management systems
Responsibilities
Prepare and submit regulatory dossiers for assigned international markets; Coordinate with distributors and internal stakeholders for registration activities; Support responses to regulatory authority inquiries; Participate in new product launch and market expansion projects from a regulatory perspective