Paresma Patel

Paresma (Pinky) Patel, Ph.D. is Director of Regulatory CMC Policy & Advocacy at Gilead Sciences, where she leads chemistry, manufacturing, and controls (CMC) regulatory advocacy in support of global health authority filings. In this role, she represents Gilead in multiple external forums and advances regulatory policy initiatives, including implementation of ICH M4Q (R2), ICH Q12, and evolving assessment standards. Prior to joining Gilead, Dr. Patel spent a decade at the U.S. Food and Drug Administration (FDA) (2015–2025), holding positions of increasing responsibility within CDER’s Office of Pharmaceutical Quality. Her roles included Reviewer, Branch Chief, and ultimately Division Director in the Office of Product Quality Assessment III. As Division Director, she led teams responsible for the evaluation of CMC information, with a primary focus on drug substance quality across all stages of development. During her FDA tenure, she also contributed to numerous strategic initiatives and the development of regulatory policies and guidelines. Earlier in her career, Dr. Patel worked as a medicinal chemist at the National Institutes of Health. She earned her Ph.D. in Organic Chemistry from The Scripps Research Institute (2010) and completed a postdoctoral fellowship at the California Institute of Technology (2012).