The FDA Group’s Nick Capman sits down with Carlos Carrillo, PhD, MSc, Senior Vice President of Regulatory Affairs & Quality Assurance at SAB Biotherapeutics. With nearly 30 years of experience across Operations, R&D, Regulatory Affairs, Quality Assurance, and Project Management, Carlos has led global regulatory strategy for small- and large-molecule programs from Phase 1 through launch. He has prepared IND/IMPD/CTA/CTR/BLA/MAA submissions across multiple regions, secured expedited designations, managed FDA and ex-US health authority meetings, and built RA/QA systems for growing biotech organizations.
Carlos shares practical, experience-tested guidance on how small and mid-size biotech companies can build regulatory resilience: strengthening governance, preparing for FDA interactions, improving documentation discipline, and integrating external partners without losing control.
He also breaks down how to evaluate vendors, structure joint governance, embed QA into outsourced workflows, and design audit-ready data flows that prevent institutional knowledge loss.
Topics discussed include:
Why early regulatory infrastructure prevents costly rework
Leadership behaviors that shape regulatory culture
How to prepare for high-stakes FDA and ex-US health authority meetings
The risks of “tribal knowledge” in fast-moving organizations
A structured model for evaluating and managing external partners
How small companies can stay inspection-ready with lean teams
One takeaway: External partners can be force multipliers or liabilities—the sponsor’s structure and oversight determine which.
About The FDA Group:
The 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 specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations.
https://www.thefdagroup.com/
