Law has a bar exam and a clerkship. Medicine has residency. Accounting has a CPA and years under a supervising partner. Regulatory affairs has none of that — no license, no mandatory apprenticeship, no structure that guarantees anyone teaches you how to think about an ambiguous call before you are the one making it. What fills that gap, for the people who turn out good at this work, is almost always a person: someone who let them watch a real decision get made and explained why.
What a regulatory mentor actually gives you
The valuable thing is not an answer key. It is watching someone reason through an ambiguous call in real time: why this labeling change felt like it needed a fresh look, why that predicate argument was weaker than it first appeared, what made them uneasy enough to ask one more question before signing off. That kind of reasoning rarely survives being written down as a rule, which is exactly why it has to be transmitted person to person. A mentor is also, usefully, not the same thing as a manager. A manager has your deadlines and their own incentives bound up in your work; a good regulatory mentor can sit anywhere — quality, clinical, a more senior peer on another team — as long as they are willing to think out loud with you. Our honest map of how people actually get into regulatory affairs covers the earlier version of this problem: almost nobody arrives with a formal credential, and mentorship is a large part of how the gap actually closes.
How the ask actually works
“Can I pick your brain sometime” is easy to say yes to and easy to let quietly expire, because it asks for nothing specific and offers nothing back. A better first ask names one artifact and one kind of feedback: would you read this paragraph and tell me if the risk framing holds up, would you look at how I responded to this reviewer question and tell me what you’d have cut. It is small, it is finishable in fifteen minutes, and it gives the other person something concrete to react to rather than an open-ended obligation. Cross-functional work is where a lot of these relationships actually start, because it puts you next to people whose reasoning you can watch without asking permission first — the same rooms where explaining a regulatory decision to someone outside the function is its own skill worth building. After the ask, the part people skip is closing the loop: going back afterward and saying what you did with the feedback. That single follow-up is most of what makes someone willing to say yes the second time, and the pattern of a normal working day where these moments happen is covered in a day in regulatory affairs.
- Pick one specific artifact — a paragraph, a response, a decision — not a general request for mentorship.
- State exactly what kind of feedback you want: tone, completeness, or whether the risk read is right.
- Keep the first ask under fifteen minutes of their time. Trust is built before it is spent.
- Close the loop afterward, in writing, on what changed because of what they said.
- Offer something back before you are asked — notes from a meeting they missed, a first pass at something tedious.
Two habits that quietly end a mentorship before it starts
Asking to “pick their brain” instead of about one decision
An open-ended request forces the other person to do the work of figuring out what you actually need, which is exactly the work you were hoping to save them. A narrow request about one real decision does that work for them.
Disappearing after getting the answer
Getting feedback and never reporting back what happened to it reads as the exchange being one-directional, even when that was never the intent. The follow-up is not a courtesy; it is most of what makes the next ask easier.
Sources & further reading
- Regulatory Academy — How to Get Into Regulatory Affairs, the honest map regulatoryacademy.com
- Regulatory Academy — A Day in Regulatory Affairs, what the work actually looks like regulatoryacademy.com
- Regulatory Academy — The 510(k) Pathway, a free five-lesson course regulatoryacademy.com
This essay is provided for general educational purposes and reflects the regulatory landscape as of its publication date. It is not legal, regulatory, or career advice.
