I-Hsun Chen Email & Phone Number

Regulatory- Maintain the effectiveness of product license and facility license.- Work with global/ regional RA to conduct the UDI requirement.- Organize the submission dossier on the quality management system (Agile, Veeva).- Manage the package material to qualify the local requirement.Quality Assurance- Establish and optimize the local procedures.- Provide advices to logistic team for rising the awareness of quality.- AEs/ compliant cases handling. Monitor the post-approval product and provide the feedback to global team on time.

Regulatory- Cooperates with Health Authority on the COVID-19 project.- Maintain the license, work with client internationally to apply the extension of product licenses and facility approvals.- Collaborate with the Business Development team and the Regional RA team to evaluate the new product project. Providing the professional information and suggestion for the teams.- Organize the promotion material code systematically and work with the medical team with the materiel management.Pharmacovigilance- The primary contact of the PV to the client and report directly to regional PV lead.- Assisted the client in establishing the file format of the ICH E2B (R3) for the Taiwan ADRs reporting system which increased the effectiveness of case reporting by 75%

Regulatory- Applied for NHI reimbursement regarding medical device. Provided relevant regulatory information and suggestions for marketing and sales teams to formulate business strategies.- Handled adding domestic or foreign secondary package site plans for drugs by providing regulatory information and evaluation strategies.- Evaluated the strategy for license application in Taiwan for medical device that outsourced secondary packaging abroad.- Monitor and analysis the regulations change. Providing the comments and solutions to the stakeholders.Quality Assurance- Maintained Good Distribution Practice (GDP) approval.- Wrote a drug recall procedure to handle quality warnings and defective product recycling.Pharmacovigilance- Managed ADR cases. Uploaded cases to the Taiwan ADRs reporting system.- Completed signal detection report of PV. Analyzed and monitored for abnormalities based on reports.

- Assisted with the application for adding the manufacture of new dosage form for GMP.- Applied manufacture site change and change form for compliance.- Built a food traceability system and process according to regulations by the effective date.- Organized GMP, GDP, ISO 22000, and ISO 9001 documents.