Ying Liu

- Spearheaded end-to-end regulatory compliance strategies for global pharmaceutical clients, focusing on China market entry, product approval acceleration, and risk mitigation. - Delivered tailored regulatory roadmaps for imported drugs, including NMPA IND/NDA submissions and comparative analysis of global regulations (FDA/EMA/NMPA). - Advised cross-functional teams on GxP compliance and market access frameworks, aligning stakeholder priorities with regulatory milestones.

As the End-to-End Lead (Project Management, Regulatory Strategy & Clinical Execution) for a COVID-19 mRNA vaccine program, successfully steered the vaccine from early R&D to pre-IND submission by aligning cross-functional teams (R&D/CRO/manufacturing) with NMPA requirements.

Was responsible for overseeing and managing all RA, PV & QA activities, played a crucial role to drive the decision-making, planning and execution of business initiatives. - Regulatory Leadership: Secured priority-review NDA approvals and accelerated BLA approval through innovative data strategies. - Global Compliance Optimization: Established China’s first Product Lifecycle Management system, adopted as a global best practice, improving cross-functional efficiency. - Team Transformation: Restructured RA/PV teams to focus on pre-market risk assessment, enhancing collaboration with HQ via dotted-line reporting and mentorship programs.

Led all the RA efforts related to biological products for oncology, fertility, neurodegeneration, anti-allergic, and biosimilar products and medical devices.

Led the regulatory affairs related to anti-infection, urinary, anti-pain, ophthalmic and oncology products

Be responsible for gynecological/contrast media/oncology products’ IND/NDA and post-marketing management, meanwhile, represented China RA team to support internal audit and patent/trademark registration and management.

Was responsible for the regulatory affairs related to obstetrics and endocrine products; contributed to INDs/NDA approval and clinical trials; established of local manufacturing site plan including the setup of regulatory process & milestone & timeline for local product manufacturing.