Qiubin Yang

1. Global Regulatory Submission Support Participated in 5+ regulatory submissions including biosimilars HLX04, HLX11, HLX14 and innovative drug HLX10 across FDA, EMA and PMDA; responsible for IR preparation and dossier review. 2. SOP Development and Compliance Management Led the establishment of 4+ SOP documents and optimized RA internal workflows covering BLA, IND and IR response processes. Reviewed regulatory-related content in SOPs from other departments. 3. Company Core Data Sheet (CCDS) Management Independently drafted 4 SOP documents, finished flowcharts design and cross-functional reviews: established CCDS and labeling management standards. Successfully created CCDS file for HLX10. OA E-approval Workflow: Collaborated with IT to build online approval workflow, enabling cross-departmental sign-off and automated reporting. 4. Business Partner and CRO Communication Managed RA coordination with CMIC (Japan CRO), Henlius JP, Parexel and other partners; responsible for strategy alignment and progress management to ensure efficient collaboration. 5. Japan PMDA Submission Support Participated in HLX10 and HLX14 PMDA pre-consultation meetings (Japanese); reviewed Japanese-language materials; familiar with Japan regulatory requirements. 6. FDA Electronic Submission Preparation and Filing Leveraged research experience to create XML-format SPL files for HLX04, HLX11 and HLX14, conducted xForm tool testing and CDER submission with 100% FDA technical validation approval. 7. Veeva RIM System Engaged directly with Veeva CSM to optimize system configuration to align with business scenarios. 8. AI exploration for Regulatory Science Successfully developed and launched 2 AI applications with IT team, covering regulatory knowledge base and competitor product monitoring systems. Strictly controlled regulatory delay risks. Responsible for US, EU and Japan regulatory tracking.

1. NDA Registration and Regulatory Support Participated in 5+ innovative drug NDA registrations (including Paxlovid), coordinated with CMC, non-clinical, and clinical teams for preparation of submission dossiers. China: Vyndaqel/Vyndamax, Revatio, Rimegpant Hong Kong: Staquis, Xeljanz Japan: Paxlovid 2. Multi-Market Labeling Lifecycle Management 300+ items annually: labeling creation, review, submission and maintenance for China mainland, Hong Kong, Japan and Pakistan markets. 3. Regulatory System Optimization and Automation Exploration Served as COMPASS system SME (communication, storage, project monitoring, product status updates); conducted regular system operation training to improve team collaboration efficiency. Early exploration of AI agents and process automation integration into regulatory workflows. 4. Regulatory Communication and Compliance Response Handled 50+ HA Queries annually (including CDE, PMDA), revising relevant information with average response time <48 hours. 5. Electronic Labeling Innovation Project Led first-of-kind electronic labeling pilot project; collaborated with vendor team to develop web platform, driving industry regulatory publication. Led promotion of XML-format Japanese drug labeling editing workflow. 6. Global Regulatory Strategy and Industry Contribution In-depth analysis of USPI, SmPC and J-PI regulatory differences; developed adaptive labeling strategies. Contributed to CDE "Drug Labeling Elderly-Friendly Revision Guidelines" consultation. 7. Cross-Functional Collaboration and Team Management Collaborated with drug safety team to periodically produce labeling safety information reports; served as Viatris product labeling management manager to ensure submission timeliness.