Manda Pasarkar

Global Regulatory Team Lead at Sanofi

Speaker

As the Director of global regulatory affairs at CMC, I lead the clinical and commercial portfolio for small molecules, driving innovation and compliance. With over 20 years of extensive experience in the pharmaceutical industry, I have successfully navigated diverse modalities, including biologics and synthetic products. My expertise as a subject matter expert (SME) in Regulatory CMC, coupled with my coaching and mentoring skills, allows me to inspire teams and effectively tackle complex regulatory challenges.

Having served as an SME for the FDA’s prior approval inspections, I possess a deep understanding of global regulatory frameworks from esteemed health authorities such as the EMA, CMDH, FDA, Japan, and China. My track record includes successfully registering and managing product life cycles on a global scale while proactively resolving supply chain issues to ensure seamless operation.

I am dedicated to cultivating a high-performing team that values work-life balance, positioning myself as a strategic partner to R&D, manufacturing, and supply teams. I believe together, we can achieve remarkable results and elevate our organization to new heights in the competitive pharmaceutical landscape.