Lead Regulatory Affairs Specialist, Japan
and take appropriate action with detailed supervision of direct manager or project leader.) Supports regulatory inspections...
and take appropriate action with detailed supervision of direct manager or project leader.) Supports regulatory inspections...
in activities associated with regulatory inspections. Study documents/materials Management Initiate and maintain production...
inspections, responding to PMDA inquiries when applicable, preparing product quality standard document, etc.) and renewal of MAH...
office printer functionality in good working order. Assists with handling government inspections 3...
, as applicable, based on local legislation. Perform periodic Depot Self-Inspections as required, to assure everything at the...
society rules, international regulations, and statutory requirements during surveys and inspections. Apply new regulations... in compliance with rules and regulations by means of compulsory inspections, tests and trials, − to issue Certificates, Reports...
and maintain internal management reports to track metrics and controls Support inspections and audits with timely data, evidence...
and monitor the performance of subcontractors Facilitate and respond to internal, external and authority inspections or audits...
, as applicable, based on local legislation. Perform periodic Depot Self-Inspections as required, to assure everything at the...
Health Authorities (PMDA/MHLW), being accountable for Local PV inspections. Is accountable for all PV related activities...