About this role
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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