The position must have full knowledgement of Local regulatory law in regards to all company related product.
Must to support the company’s New project introduce to the market to purpose examination and registration etc.
To keep the company informs of the latest regulations and policies introduce by the government in time in order not violate the local government regulatory law and to avoid any fine/penalty accrue.
For protecting company’s benefit.
To lead a team of Taiwan Regulatory Professionals, optimize team and activities to achieve speed to market.
To provide strategic input to all new regulatory filings and to achieve rapid submission and approvals of product registration.
Regulatory intelligence and active cross-functional collaboration to meet company goals.
Supports and manages the data acquisition aspect of activities of clinical trials to ensure that study objectives are met within established timeframes, budgets and scope.
Develops and implements programs, policies, procedures to establish and maintain quality standards of existing products, as well as developing programs to focus employees on quality improvement.
Managing and monitoring the security of the medications of the company, through the analysis of adverse events reports and of their submission process, aiming to ensure the company’s internal and regulatory compliance.
Medicinal Products (pharmaceutical, biological)
(2) Product License Maintenance Renewal
Variations (license transfer, changes of labeling/specifications/site, manufacturer name/address change, company name/address change, etc)
(3) Registration Consultation
Principal consultation regarding registration issues e.g category, requirements, timeline, cost, etc.
(4) Support product exportation
(5) Manufacturing Contract for OEM products
(1) Clinical trial protocol and report submission.
(2) Preparation and submission of the optimized Bridging Study Evaluations (BSE) report.
All QA issues.
To serve as TW Safety Officer and to ensure timely report of Adverse Events to both local HA and regional headquarters.