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.