The first ninety days in a new regulatory affairs role are not about producing your best work. They are about learning where the real information lives, who actually signs off on what, and how this particular employer does the things you already know how to do somewhere else.
Learn the system before you touch the queue
Every employer’s document control system organizes controlled procedures, forms, and records a little differently, even though the underlying regulatory requirement behind it — a documented quality system under the QMSR, 21 CFR Part 820, for device makers — is the same everywhere. Spend real time in it before generating anything of your own: find the current procedure that governs the kind of work you’ll be doing, find who owns it, and read two or three of the most recently closed files start to finish. That shows you what “done” actually looks like at this employer, which is not always the same as what the procedure says it should look like on paper — a gap that matters more day to day than most of what a textbook covers, closer to the ground-level view in a day in regulatory affairs than to any formal training.
Ask sharper questions than “what do I do”
A new hire who asks “what do I do” gets a generic answer. A new hire who asks “who has final sign-off on a submission like this one” or “has this kind of question come up before, and how was it handled” gets something specific, and starts building an internal map that no textbook has — closer to the informal, relationship-based learning covered in finding a mentor in regulatory affairs. It also helps to ask who is actually accountable for a decision, not just who happened to answer first; the fastest reply in a new building is not reliably the most authoritative one.
- Find the document control system and learn its naming and numbering convention.
- Identify who holds final sign-off on a submission or change, not just who reviews it.
- Read two or three recently closed files start to finish, not just the current procedure.
- Ask about one live open question this quarter, instead of a hypothetical one.
Two habits that slow a new hire down
Mistaking early confidence for competence
Regulatory judgment is built by pattern-matching across many submissions over time. A strong opinion formed from one or two files at a new employer is usually a guess wearing more certainty than it has earned.
Learning the rules but skipping the people
The regulation is the same everywhere. How a specific employer actually gets a submission signed, and by whom, is rarely written down as clearly — and it is usually the thing that actually slows a new hire down.
Sources & further reading
- FDA — Quality Management System Regulation, 21 CFR Part 820 ecfr.gov
- Regulatory Academy — A Day in Regulatory Affairs regulatoryacademy.com
- Regulatory Academy — Finding a Mentor in Regulatory Affairs regulatoryacademy.com
- Regulatory Academy — How to Get Into Regulatory Affairs 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.
