How Sanofi Navigates Regulatory CMC Across Global Markets: Insights From Manda Pasarkar

If you think regulatory CMC is primarily a compliance function, Manda Pasarkar's perspective will change that. As Global Head of Regulatory Affairs CMC at Sanofi, she oversees regulatory strategy across biologics and small molecules for a multi-billion dollar portfolio spanning the US, EU, Japan, and China. Her core point: when you center patient safety, you naturally align with what health agencies actually want.

With a master's in chemistry and a deep interest in law and regulation, Pasarkar occupies a rare intersection. That combination matters because, as she puts it, not every regulation fits every product. Knowing when to apply which framework, and how to adapt across the FDA, EMA, and Japan's PMDA, is what separates reactive compliance from proactive regulatory strategy.

The conversation also covers what productive CDMO partnerships actually look like, how ICH guidelines function as a common language across markets, and why AI is starting to reshape how regulatory teams work. Specific, experience-grounded, and notably candid. Listen now to build a sharper approach to global regulatory CMC.