Director, Therapeutic Area Head of China Regulatory Strategy, Gastrointestinal and Inflammation

Description

1.Regulatory Strategy for new products & life cycle management: leads the therapeutic area regulatory strategy team to secure timely regulatory approvals of new products, and post-approval variations by developing innovative approaches, including providing regulatory inputs in a timely manner to de-risk drug development to support successful product launches

2.Analyze and compare regulatory outcomes against initial product concepts; offer recommendations for future strategies and continuous improvement.

3.Registration maintenance: responsible for managing the product life cycle, upholding rigorous compliance to maintain product licenses.

4.Assists to advance the organization’s approach to incorporate China regulatory requirement in an efficient and forward looking matter into drug development and product life cycle, anticipating potential regulatory challenges and emerging issues, and ...