Senior Associate
PwC
Overview
Chai has more than 9 years of life sciences industry experience with skills that span regulatory and clinical operation, global regulatory strategy, and product development and commercialization strategy. Prior to joining PwC, Chai previously worked at Abbott Laboratories and BD, providing regulatory support for new product development, labeling changes, maintaining ongoing design changes, and supporting line extension activities.
Relevant experience
Supported a pharmaceutical client with global labeling management program to align labeling process, core data sheet, and local labeling to approved MAs
Supported COVID-19 in-vitro diagnostics test kit manufacturer with EU re-certification strategy, mock audit, and remediation activities
At Abbott, Chai has acted as the RA lead by delivering a comprehensive regulatory/clinical strategy and developing global submission packages for product registration, including Indication For Use changes and Abbott packaging/labeling re-branding rollout worldwide
In addition to Chai’s regulatory experience in the US, EU, AUS, JP, and Taiwan, Chai was recognized as a China special Matter Expert for all Abbott’s Business Units
At BD, Chai led the efforts to draft, review, and submit regulatory submissions with FDA, including the collaboration with the cross-functional teams and hosted FDA pre-sub meeting for product design and Indication For Use changes
Disclosure information not submitted.
Tuesday, September 13, 2022
11:15 AM – 11:45 AM MST
Tuesday, September 13, 2022
12:00 PM – 12:30 PM MST