Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli
About this episode
Tammy Sarnelli discusses the differences and similarities in regulatory leadership between large pharma and small biotech companies.
What actually changes for regulatory leaders when they move between large pharma and small biotech, and what stays the same? Tammy Sarnelli draws on over 35 years of experience across organizations of every size to break down the real differences in workload, risk tolerance, resource access, and culture. Tammy discusses how organizational silos create friction in large companies, why limited resources at small companies can actually accelerate decision-making, and how risk tolerance shapes not just strategy but the speed at which products move forward, especially in rare disease. A few of Tammy's key takeaways: Regulatory expectations are the same regardless of company size — it's the day-to-day experience and workload distribution that differ Silos in large organizations restrict collaboration and can fragment how a company approaches health authority interactions Small companies benefit from "all-in thinking" — fewer programs mean faster alignment, but leaders must fill multiple roles simultaneously Risk tolerance is cultural, not organizational — when people aren't punished for good-faith decisions, they move faster Regulatory "failure" can mean not taking…
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