BACKGROUND
FOCUS AREAS
Extensive regulatory experience in managing projects, authoring documents, and ensuring global compliance strategies.
Regulatory affairs, pharmacovigilance, clinical consulting, specializing in regulatory submissions, lifecycle management, FDA communications, and ensuring compliance with global standards for innovative therapies.
As a Clinical consultant/safety Specialist of ELIQUENT Life Sciences, Ziqi Zhang specializes in IND maintenance, regulatory consulting, and medical writing, supporting regulatory strategy and compliance.
Ms. Zhang has managed multiple IND maintenance projects at ELIQUENT, including but not limited to safety report submission, clinical protocol/IB review and submission; the Development Safety Update Report (DSUR) and Orphan Drug Designation (ODD) annual report review & submission; as well as CMC amendment submission. These projects included Phase I, II, III and post marketing stage. The products ranged from monoclonal antibodies, bispecific antibodies, small molecular drugs, to CBD products targeting different indications involving solid tumors, autoimmune diseases, and central nervous system (CNS) diseases. Ms. Zhang also had experience with multiple fast-track designation, ODD feasibility assessment and application package writing in both oncology and non-oncology disease area. Ms. Zhang also provides ad hoc consulting and gap assessments. Additionally, she has experience in the project management and regulatory affairs including PIND, IND, BLA and NDA projects. She has been agile in managing projects and successfully supported multiple IND applications, all receiving Sample May Proceed (SMP) letters. Ms. Zhang is passionate about innovative drug regulation and exploring the potential of AI in pharmacovigilance.
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Education:
Master of Science in Global Health, Duke University
Bachelor of Preventive Medicine, School of Public Health, Fudan University -
ELIQUENT Life Sciences | Clinical Consultant/Safety Specialist | Aug. 2022 – Present
This role mainly focuses on medical writing and safety reporting.
• Medical writing: Authored 30+ regulatory documents, including 8 ODD requests and 4 FTD requests, all of which received FDA designation. Experienced in writing DSURs, ODD annual reports, EOP1 meeting packages, ICFs, Module 2.5 clinical summaries, and GIPs for documentation and regulatory compliance.
• Pharmacovigilance and IND Maintenance: Identified the reportability of safety events; Improved SUSAR reporting efficiency by 30% and maintained 100% compliance rate with global pharmacovigilance standards.
• Lifecycle Management: Managed 60+ IND maintenance contracts with timely regulatory submissions (protocol/IB amendments, PI updates, nonclinical, CMC amendment). Achieved high client satisfaction and contract renewals.DataRevive USA LLC | Regulatory Project Manager | June. 2021 – Aug. 2022
This role mainly focuses on regulatory submission, project management, and interaction with FDA.
• Regulatory Submission: Successfully managed 15+ PIND and IND submissions to both CDER and CBER. Achieved approval within FDA timelines.
• Regulatory Intelligence: Conducted a regulatory intelligence project on clinical trial termination in 32 countries, market landscape analysis for providing critical insights for strategic decision-making and ensuring compliance with diverse global regulations.
• FDA Interaction: Facilitated 10+ FDA meetings, including EOP2 sessions, by organizing detailed rehearsals with clients and preparing comprehensive briefing documents. Serve as the point of contact for information request during IND 30-day review.
• Project Management: Coordinated cross-functional teams, successfully delivering 5+ urgent submissions, enabling delivery ahead of deadlines without compromising quality or compliance.
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