Minghua Liu, Ph.D.

Works with internal and external partners to deliver products to patients by preparing CMC regulatory strategies that enable first-pass approvals. Develops and manages content strategies for regulatory submissions, including INDs/CTAs, amendments, new marketing applications, renewals, supplements, and variations. Builds and maintains relationships within Regulatory Affairs, Operations, and R&D organizations; represents CMC on product development teams, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. Responds to regulatory information requests and prepares for agency meetings, including development and management of pre-meeting content. Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies. Analyzes and interprets information, legislation, regulation, and guidance that impact regulatory decisions; provides insights and strategic input to the organization. Manages products and change control activities in compliance with relevant regulations and internal procedures; analyzes and approves manufacturing change requests. Develops, implements, and documents RA CMC policies and procedures; participates in internal initiatives and cross-functional projects to drive efficiencies. Negotiates with and influences team members with support of management to maximize chances for first-pass approval of regulatory submissions. Stays current with regulatory procedures and changes in the regulatory landscape.

CMC Consulting for domestic and international companies at various stages of development (pre-IND, early phase IND, IND amendment, BLA, etc.), facilitating submissions and communications with regulatory authorities. In less than 3 years, participated in the completion of 25+ IND submissions, multiple amendments, BLA writings and reviews, and provided ad hoc consulting services. Currently, 4-5 CMC writing and reviewing projects are ongoing. All completed projects received safe-to-proceed letters from the FDA with no clinical-hold issues. Assisted a cell therapy sponsor in releasing an IND clinical hold via a filing exemption letter. Participated in BLA CMC Module review within the first year as a CMC consultant. Extensive hands-on experience in CMC filings for diverse product types, including monoclonal antibodies, ADCs, mRNA-LNP, bispecific/trispecific proteins, CGTs, and HCT/Ps. Provided full support on regulatory communications, including pre-IND meeting requests, package preparation, urgent information requests, and safe-to-proceed follow-ups, leveraging a deep understanding of regulatory strategies and trends to navigate agency expectations. Regularly supported clients from China by offering bilingual (English/Chinese) guidance, ensuring they understood regulatory requirements. Trained and mentored junior consultants to help them quickly adapt to CMC dossier writing. Authored multiple CMC regulatory white papers and delivered bilingual presentations at conferences, receiving positive feedback. Actively involved in business development, contributing to the signing of new contracts with current and potential clients. Contributed to the development of internal databases to improve workflow and assisted with extra tasks to ensure timely and high-quality project completion. This revision includes the additional detail regarding your understanding of regulatory strategies and trends.

Responsibilities: Supported cGMP compliance assurance, SOPs review, revision, and implementation. Reviewed labels and labeling to ensure compliance with relevant regulations. Acted as a liaison with FDA officers to ensure compliance with FDA requirements and supported the resolution of compliance issues. Inspected raw materials and final products to assess compliance with quality standards and established tolerances. Identified and assisted in resolving non-conforming product issues. Supported the customer service team on product information and quality-related inquiries. Managed production scheduling from raw material purchasing to final product release to maintain optimal inventory levels. Conducted raw material sourcing to ensure high-quality standards at reasonable costs. Achievements: Initially employed as an Article Archivist, promoted to Quality Control within three months, and subsequently advanced to Regulatory, QA/QC, and Production Manager within half a year of joining the company. Successfully resolved regulatory issues with the FDA, including import detentions, on-site inspections, and non-compliant label reconditioning. Significantly enhanced SOP implementation through documentation revisions, production team training, and inspections. Strategically replaced unreliable vendors and contracted manufacturers, resulting in an 80% decrease in customer complaints related to product quality. Developed more efficient workflows for quality monitoring, inventory management, production, and customer service support, increasing efficiency by at least 80% and reducing out-of-stock instances by at least 60%. Successfully maintained sufficient inventory of popular products during the COVID-19 pandemic to meet significantly increased demands, some of which increased by more than 600%. Supported the development of several essential new products and improvements to existing products using knowledge from a professional biology education background.

Responsibilities: Product Label Review, Publication Archiving, Writing Scientific Reviews for Herbs and Supplement Ingredients.

Responsibilities: Wrote and reviewed detailed label review reports and provided revision suggestions to ensure compliance with FDA and other US regulatory requirements. Achievements: Initiated professional label review report writing after less than 2 weeks of training, despite having no prior regulatory experience. Successfully managed the simultaneous writing of over 7 professional label review reports within the same timeframe, completing them on time and with outstanding quality.

Electron microscopy and Con-focal microscopy for yeast septin fibers and sub-cellular structures.