Xiuli Chen
Quality and Regulatory Affairs
- Role
- Sr Director, Head of Quality and Regulatory Affairs at Roosterbio Inc
- Location
- Clarksburg, MD, US
- LinkedIn followers
- 500 followers
About Xiuli Chen
Goal-oriented and results-driven professional with 20 years of experience in quality, regulatory affairs, and analytical sciences. Proficient in drug development, IND, quality control and quality system management. In-depth knowledge and understanding of FDA, EMA, ICH guidelines. Experienced leader in talent development and project management.
Experience
Sr Director, Head of Quality and Regulatory Affairs
Apr 2025 — Present · MD, US
Lead Quality (QA/QC) and Regulatory Affairs functions supporting the development and manufacturing of human mesenchymal stem/stromal cells (hMSCs), exosomes, and cell-derived particles. Oversee Quality Management Systems, regulatory submissions (including DMFs), and ensure compliance with GMP standards across 2D (e.g, flasks, cell stacks) and 3D bioreactor-based manufacturing platforms. Provide strategic oversight to align early product development with global regulatory requirements.
Education
Cornell University
Ph.D, Molecular Biology and Genetics
1995 — 1999
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