Vacancy Description
- Regulatory Submissions & Change Notification Governance: Coordinate and track timely submissions for product registrations, renewals, and variations across Asia. Own the end-to-end process for regulatory change notifications, ensuring impact assessments, documentation readiness, and submission tracking in partnership with country RAQA and global teams.
- Regulatory Intelligence, Labelling & UDI Compliance: With the support of local RAQA, monitor evolving Asia regulations and provide strategic insights on labelling and UDI requirements. Support impact assessments, update SOPs/templates, and disseminate regulatory intelligence to country teams to ensure compliance and traceability.
- Complaint Handling, FSCA & Recall Execution: Lead regional coordination of complaint intake, triage, and resolution. Manage FSCA and recall processes, ensuring timely execution, regulatory reporting, and effective field actions in collaboration with Quality, Supply Chain, and Commerc...
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