China Regulatory Affairs Specialist

Regulatory Affairs Operations
Prepare, compile, review, and submit regulatory documentation for product registrations, renewals, amendments, notifications, and other lifecycle management activities in Hong Kong and Macau.
Coordinate with internal stakeholders to obtain required technical, quality, clinical, and regulatory documentation to support submissions.
Maintain regulatory licenses, approvals, certificates, and product registration databases to ensure continued compliance.
Monitor approval status and follow up on regulatory submissions to support timely market access.
Support regulatory assessments for product changes, labeling updates, manufacturing changes, and other regulatory impact evaluations.
Quality Assurance Activities
Support complaint handling activities in accordance with company procedures and applicable regulatory requirements.
Assist with complaint documentation, investigation follow-up, trending, and record maintenance.
Support post-market surveillance and vigilance activities where applicable.
Maintain quality records and documentation in compliance with Quality Management System requirements.
Assist with field actions, recalls, advisory notices, and other quality-related activities as required.
Regional Regulatory Support
Prepare and submit regulatory dossiers for assigned international markets.
Coordinate with distributors, authorized representatives, and internal stakeholders to support registration and maintenance activities.
Support responses to regulatory authority questions and requests for additional information.
Maintain regulatory records and approval status tracking for assigned markets.
Participate in new product launch and market expansion projects from a regulatory perspective.
 

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