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There's a question that sits underneath a lot of career decisions in regulatory affairs: where can you create the greatest impact?
Is it in a large organization with deep resources but layers of silos and stakeholders? Or is it in a small company where you're wearing every hat but moving at a pace that can directly shape a product's trajectory?
The answer, it turns out, depends less on company size than most people might think.
Our own Nick Capman recently sat down with Tammy Sarnelli, Senior Vice President/Global Head Regulatory Affairs and Clinical Quality at Amylyx Pharmaceuticals, to talk through the distinct pressures regulatory leaders face in large and small organizations, and the capabilities that matter regardless of where you sit.
Tammy brings over 35 years of regulatory experience spanning organizations of very different sizes and structures. She spent 27 years at Biogen as Senior Director, then moved to Bioverativ (a rare disease spinout later acquired by Sanofi) as Executive Director, served as Head of Global Regulatory Affairs at EMD Serono (part of Merck KGaA), and has spent the past five-plus years at Amylyx Pharmaceuticals, where she now leads both regulatory affairs and clinical quality.
That range — from one of the industry’s largest organizations to a small, rare disease-focused company — gives her an unusually grounded perspective on what actually changes between environments and what stays the same.
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Tammy’s key insights and practical takeaways
If you’re short on time, here are the most important lessons from the discussion.
Regulatory expectations are the same regardless of company size. The day-to-day experience is what differs. Whether you’re at a large pharma or a five-person regulatory team at a startup, the job is the same: provide a clear regulatory strategy that guides clinical design, CMC planning, safety strategies, and commercial readiness. You’re still scanning the horizon, researching guidance and precedent, developing trusted dynamics with regulators, and delivering complete, consistent, persuasive documents, first time, on time. What changes is the workload and how it’s distributed. At a large company, you’re likely managing multiple programs across multiple indications with different challenges and approaches. At a small company, there are fewer programs (sometimes just one), but you’re often jumping between fires, filling multiple roles (developing strategy, writing documents, publishing them, pulling references) all in the same day.
Organizational silos are one of the hardest friction points in large companies. Large organizations have large teams, often separated by therapeutic area or indication, and communication doesn’t always flow freely between them. When information is restricted, collaboration suffers, transparency drops, and knowledge sharing stalls. Regulatory strategy isn’t black and white! The landscape is always evolving. Without sharing openly cross-functionally, opportunities to adjust, adapt, pivot, or expedite development get missed. It also fragments how a company approaches health authority interactions: different therapeutic areas may take entirely different approaches rather than aligning on a consistent company-level strategy. Tammy’s view is that intentional, thoughtful relationship building and knowledge sharing across regulatory teams is critically important for reducing misalignment.
In small companies, limited resources force sharper prioritization. With fewer people and tighter budgets, leaders have to work more efficiently. Decision-making can actually be faster since there are fewer consultations needed to reach alignment. But that speed comes with a tradeoff: you need to be on top of every potential expedited regulatory mechanism (fast track designations, new pilot programs like the START program) and constantly evaluate whether your program is eligible. Tammy describes this as “all-in thinking” — at a small company with one or two products, everyone in the organization is working on the same thing and can be flexible with workload. You’re constantly asking: what is the most important thing I need to work on today?
Larger companies have earlier access to regulatory intelligence; smaller ones have to build their own. Large organizations are more likely to have dedicated regulatory intelligence teams monitoring the landscape, government affairs colleagues gathering information directly from health authorities, and the resources to participate in trade associations like PhRMA and BIO that advocate for policy and guidance. At a smaller company, you’re relying on public information from trade publications, scouring health authority websites, and by the time something is published, the landscape has already progressed further. Tammy’s advice: master and grow your professional network. Consulting with other professionals about what they’re seeing can help close the intelligence gap.
Breaking down silos requires curiosity and authentic relationship building, not just process. Tammy’s approach in large organizations has been rooted in asking questions — being genuinely curious about what colleagues are working on, connecting both professionally and personally, and leaving space for information gathering and sharing. That curiosity builds the relationships that actually break down silos. It’s not a communication framework or governance mechanism. It’s the willingness to be authentic with colleagues and to make time for the connections that allow information to flow.
Risk tolerance is about culture, not company size, and it directly affects speed. Tammy draws a clear distinction: a risk-tolerant organization doesn’t eliminate risk: it means aligning strategy with action, socializing risk, understanding what actions you can take, and sometimes accepting risk. She used the example of pursuing a Fast Track designation, which requires demonstrating that a therapy “has the potential to improve” — not proof, potential. That potential isn’t always fully understood early in development. An organization has to decide whether it’s worth investing time and resources in that request when the outcome isn’t guaranteed. When people know they won’t be punished for thoughtful, good-faith decisions that involve risk, they make decisions faster. That mindset catalyzes speed. Employees aren’t waiting for certainty, they’re optimizing for informed movement.
“Failure” in regulatory can mean not taking a chance when you had one. Tammy reframes the idea of regulatory failures and near misses. In large organizations, teams may avoid pursuing riskier health authority interactions (breakthrough therapy designation, PRIME in Europe) because success isn’t guaranteed, so why allocate resources? But for smaller organizations, especially in rare disease, the calculus is different. Patients living with these diseases don’t have time for teams to hold back. Near misses, in Tammy’s framing, are the opportunities you didn’t pursue.
AI is reshaping regulatory work, but adoption depends on resources. New technologies and AI are reshaping the landscape for companies of all sizes, but the ability to adopt them differs. Larger companies, with more workforce and budget dedicated to researching and evaluating new tools, may adopt faster. Smaller companies face financial constraints that require calculated choices about when and what to introduce. One area Tammy sees evolving rapidly is AI in medical writing. AI can now accelerate accurate, efficient documentation within a structured framework, including drafting clinical study reports. What it can’t do is interpret results. The opportunity is to shift medical writing’s focus from structured formatting and comment reconciliation toward strategy, messaging, and interpretation of content.
There’s no right answer on company size, just the right fit for the right person. Tammy’s closing point is straightforward: the choice between a structured enterprise and a dynamic startup is ultimately about risk tolerance in your career. Startups bring risk, but also an enormous opportunity to learn about the work and about yourself. Large organizations offer different learning, different growth. She’s found value in every environment she’s worked in because she learned something new each time.
One thing to bring back to your team
Consider where your organization sits on the spectrum of regulatory risk tolerance, and whether that positioning is intentional or inherited.
Ask:
When your team decides not to pursue an expedited designation or a novel health authority interaction, is that a strategic decision with documented reasoning, or is it avoidance of uncertainty?
Are your regulatory professionals empowered to make good-faith decisions that involve risk, or does your culture require certainty before action?
If you’re in a large organization, is information flowing across therapeutic areas and functions, or are silos creating blind spots in your regulatory strategy?
If you’re in a small organization, have you built the network you need to stay ahead of landscape changes, or are you relying solely on public information?
The organizations that move products forward effectively are the ones that build cultures where informed risk-taking is supported, where people aren’t waiting for certainty, and where regulatory leaders can focus on the path most likely to get a therapy to patients.
Tammy Sarnelli is Senior Vice President/Global Head Regulatory Affairs and Clinical Quality at Amylyx Pharmaceuticals, where she has led regulatory strategy for over five years. Prior to Amylyx, she served as Head of Global Regulatory Affairs at EMD Serono (part of Merck KGaA), Executive Director at Bioverativ (a rare disease-focused company later acquired by Sanofi), and Senior Director at Biogen, where she spent 27 years. Across her career, Tammy has worked across therapeutic areas and organization sizes — from large structured enterprises to resource-constrained startups — with a sustained focus on rare disease.
Connect with Tammy on LinkedIn here.
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