معرفی
Sonal Jain serves as a Lecturer in the Department of Pharmacy at the University of Washington School of Pharmacy, specializing in the MS in Biomedical Regulatory Affairs (BRAMS) Program and supporting Clinical Trials/Regulatory Affairs Certificates.
Her academic background includes being an alumnus of the UW BRAMS program and holding a master’s degree in Applied Microbiology and Biotechnology from India. Professional experience spans the medical device industry where she managed 510k submissions, developed regulatory strategies for AI/ML-based products, and executed international regulatory submissions.
Her research focus centers on evolving regulatory landscapes for:
- AI/ML-integrated medical devices
- Global regulatory harmonization
- Post-market surveillance systems
- Clinical trial implementation frameworks
- Biomedical product lifecycle management
- Risk-based regulatory strategies
She teaches core courses including PHARM 516-518 (Regulatory Affairs) and PHRMRA 524-527 (Clinical Trials), emphasizing practical regulatory applications. No scientific awards or active research grants are documented in the provided materials. Her industry-to-academia transition informs curriculum development for next-generation regulatory professionals, though specific labs or research teams aren't referenced in current materials.
