Enqin LI

Had experience in a broad range of therapeutic areas, include Oncology and Immunology-inflammation. Supported local innovative and imported drugs regulatory activities in China and be responsible for initial IND and sIND preparation, sBLA filing and minimal post-marking maintenance work.

• CO-led initial IND preparation and submission, and built following indications CDP competitors intelligence for CDP discussion. Developed regulatory strategic thinking on FIH trial and fast to market.
• Coordinated Pre-BLA and sBLA submission. Well communicated with cross-functions and mapped out key documents deliverables to ensure correctness and timeline.
• Supported several imported collaborative project regulatory activities in China including Pre-IND/IND activities, HA consultation meeting and post-marketing maintenance.

Supported BD project regulatory assessment.

• Be involved in several BD projects, provided contributions to CDP discussion and China expedited pathway.

Individual expertise development

• Be proficient in BTD program and regulatory intelligence.
• Strengthened ICH guideline basic knowledge by ways of systemic learning and sharing within team.
• RA team Taskfore contributions including IND working manual, QC testing SOP and CMDE expertise consultation internal guidance.

US Aggregated Report collaboration and authoring

• Be responsible for US annual report preparation and authoring. Well communicated with US RA strategy and RO colleagues to ensure good deliverables with correctness and timeline.
• Coordinated with US/Chennai/Shanghai teams in completing 2019 Annual report FDA inspection.
• Developed and executed effective working tools to optimize working procedure.

US Safety Report collaboration and authoring

• Supported PADER report preparation and authoring.
• Developed step by step and working instructions to standardize current preparation procedure
• Updated and maintained PADER process tracking databases.
• Good presentation and preparations in leading internal and external meetings.