Moving from FDA into industry regulatory affairs

Most of the career essays in this space describe moving sideways — clinical into regulatory, a CRO into sponsor-side, quality into regulatory and back again. Moving from FDA into industry is a different kind of move, because it is the one direction where federal law follows you out the door. You are not just learning a new vocabulary or a new set of priorities. You are starting an industry job with a legal map of exactly what you can and cannot touch, and that map does not come from your new employer.

The restriction follows the matter, not the industry

The lifetime bar in § 207(a)(1) is narrower than most people assume on first reading it, and that is exactly where the confusion starts. It does not say a former FDA employee can never work in regulatory affairs, or never touch a product area they used to review. It says you can never represent another person or company back to the government, with intent to influence, on the same particular matter involving specific parties that you personally and substantially participated in while you were there — a named company’s 510(k), a specific firm’s warning letter response, a particular investigation. Walk into a new product area, or a company whose specific filings never crossed your desk, and the lifetime bar has nothing to say about it. § 207(c) works differently: for employees above a seniority threshold OGE sets, it adds a one-year window after leaving during which you cannot communicate with, or appear before, your former agency on any matter pending there, intending to influence the outcome — even one you never personally worked. It is broader in what it covers and shorter in how long it lasts. Confusing the two, or assuming either one amounts to a blanket ban on the industry, is the single most common misreading of this law.

Why this is not your new employer’s call to make

A hiring manager can tell you what the job requires. They cannot tell you, with any legal reliability, which specific matters you personally and substantially participated in at FDA, because they were not in the room. Only your former agency’s ethics office has that record, and the standard practice — expected, not exceptional — is to request a written ethics opinion before you accept an offer that would put you anywhere near your old caseload. That opinion becomes the reference document you and your new employer both work from, and it is worth more than any verbal assurance from either side. Skipping that step does not make the restriction disappear; it just means the first time anyone checks is after you have already acted on the wrong assumption.

What does transfer cleanly is the fluency itself — a working sense of how a division actually reads a submission, which questions a reviewer asks because the regulation requires it and which ones reflect personal judgment. Pairing that fluency with a deliberately slow first 90 days gives you room to rebuild the advocacy instincts the job now asks for, the same instincts a clinical-to-regulatory move or any other sideways transition has to build from a different starting point.