Product registration activities with local regulatory authority and support to global product registration.
Site quality management system support.
Compile registration submission documents such as common submission dossiers and register LT products with Singapore regulatory Authority and within SEA region.
Global regulatory product registrations support for SG manufactured products (Notarization and legalization/apostil of documents).
Site Quality Management System support – audits, review and update of regulatory SOPs, complaints investigation, documentation review, approval and release, involve in Post market surveillance, risk management, etc..
Support for Regulatory Awareness and related training to site staff;
Regulatory education and dissemination to the organization;
Regulatory updates to Manager
Build rapport with regulatory agencies, distributors and notified bodies as required , to perform effective and fast approvals for product registrations.
Ensure the business compliance with regional / global regulations / requirements ; such as FDA , HSA , CE IVD