Ensure that the Organization is in compliance with required regulations; Provide regulatory compliance guidance to NPI teams; develop regulatory strategies for NPIs and product registration maps. Also responsible for product registrations and regulatory inspections/3rd party audits; act as a site regulatory lead by supporting QMS.
Working closely with NPI Team to provide regulatory guidance for new product launch and registering them in various markets.
Provide regulatory strategies/ registration support for registering Food Safety instruments, Animal Health (Veterinary diagnostics) with in SEA region
Monitor the regulatory development and trends in the region and report impact to the organization.
Site regulatory support – develop regulatory procedures, corporate and external audits, authority inspections, labels and docs review and approval; complaint investigation, regulatory knowledge sharing with the staff; AO import permits and goods customs clearance support. Build rapport with regulatory agencies and notified bodies as required, to perform effective and fast approvals for product registrations.
Provide regulatory training to site staff, FSE/FAS, including QSR, local regulations, etc..
Review labeling and promotional materials for regulatory compliance.
Build rapport with regulatory authorities, RA counterparts within LT and external partners; Monitor the regulatory development and trends in the region and report impact to the organization.
Ensure the business compliance with regional / global regulations / requirements; such as FDA, HSA , CE IVD ..and advise management to take key business decisions keeping in view of local regulations and impact to the organization; participate in management reviews
Reporting adverse events/recalls to the Authority; review labeling and promotional materials for regulatory compliance