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 a chance when you had one, especially in rare disease where patients can't wait
AI is shifting medical writing from structured formatting toward strategy and interpretation — but adoption speed depends on resources
About Tammy SarnelliTammy Sarnelli is Senior Vice President and Global Head of Regulatory Affairs and Clinical Quality at Amylyx Pharmaceuticals. She has over 35 years of regulatory experience spanning Biogen (27 years), Bioverativ, EMD Serono (Merck KGaA), and Amylyx, working across therapeutic areas and organization sizes with a sustained focus on rare disease. She holds a Master's degree in Public Administration from Suffolk University and a Bachelor's degree in Biology from Saint Anselm College.
About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
