David Jiang

Global regulatory CMC team lead for multiple clinical stage oncology programs

Regulatory CMC lead responsible for NDS filing in Canada for a rare disease drug Provide regulatory assessment and submit supplements to FDA for post-approval CMC changes for DAYBUE™

Regulatory CMC lead for development products from Pre-IND to Phase 3, and the commercial product ZULRESSO®.

Regulatory CMC lead for multiple development projects in ranging from phase 1 to phase 3 Represent Regulatory CMC on various cross functional teams to develop overall CMC strategies, ensure clinical supplies and mitigate regulatory risk Author and review CMC sections for original IND/IMPD/CTA for US, EU, Canada and China, amendments, response to agency review inquiries Assess post-approval changes and author variation packages Collaborate with country regulatory teams to support global market registration

Lead CMC regulatory activities for global pharmaceutical product registrations Collaborate with cross-functional peers to develop and optimize submission strategies Perform regulatory assessment and author variation packages for post-approval changes Ensure timely submission of supplements, amendments, responses, annual reports and renewals to US and EU regulatory agencies to maintain the licenses Engage and influence FDA for concurrence on submission strategies Provide expertise to country regulatory affairs teams, manufacturing sites and suppliers

Discover oncology drugs utilizing expertise in analytical chemistry. Analyze pre-clinical data and author technical documents to support target validation, mechanism of action, structural elucidation, lead optimization, metabolite monitoring and stability.