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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