Regional Regulatory Affairs Manager
ZP Therapeutics, a Division of Zuellig Pharma
Chyue Yie Chew is the Regional Regulatory Affairs in Zuellig Pharma Therapeutics, with 10 years of experiences in regulatory market entry strategy across ASEAN countries. Her current role focuses on integrating regulatory values into business processes, with the goal to expedite patient access to new therapies in Southeast and Northeast Asia. As the regulatory project manager, she collaborated with the countries regulatory teams to successfully accelerated Covid-19 drug entry into the regions.
In the area of regulatory process improvement, she is enthusiastic in introducing data science to regulatory operation and management. She is piloting a region-wide initiative to build a data driven regulatory decision making framework, aspires to improve the accuracy of registration feasibility assessment and regulatory lead time prediction.
In her previous role in a research based company, InQpharm Group, Chyue Yie managed Medical Device CE marking applications in the EU and subsequent markets expansion to emerging countries. She was actively involved in the planning and execution of products transition from EU MDD to EU MDR.
Chyue Yie's first regulatory affairs profession in Baxter Healthcare Malaysia focused in managing pharmaceuticals products life cycle from registration to post registration compliance activities in Malaysia.
Disclosure information not submitted.
Monday, September 12, 2022
9:45 AM – 11:00 AM MST
Monday, September 12, 2022
11:15 AM – 11:45 AM MST