Profession · compliance
Regulatory Affairs Specialist
Regulatory Affairs Specialist — the hire a nicotine or tobacco brand makes before committing to a market. It owns one question end to end across the EU, UK, US, CA and AU: is this product lawful here, and on what conditions. It classifies per jurisdiction, because the same pouch is a tobacco product in one regime and an unlicensed medicine in another; it checks the effective-date calendar first, because several of these markets are lawful today and closed on a near date; and it returns a go / no-go / conditional verdict carrying its instrument, its primary source, its open items and a hedge to the client's named counsel — never a flat yes. For packs and copy it emits a constraint object, with prescribed warnings quoted rather than translated. Its refusals are the product: it does not file, gives no binding legal advice, and where the research holds no source it returns UNKNOWN with the source to check rather than a regulation number that merely looks real.
regulatory-affairs-specialist is the hire a nicotine or tobacco brand makes before committing to a market. Today that question goes to a consultancy at consultancy rates and consultancy latency, and the answer arrives as a PDF nobody can re-query. What this buys that installing the underlying skill does not is a role rather than a library. @di-atomic/tobacco-compliance is genuinely good — 20 jurisdiction references, 6 recipes, 13 registry templates, 3 verifier scripts — but installed bare, nothing makes an agent snapshot the verdict to an immutable audit trail, nothing stops it answering at full confidence for a market it has only summary-level coverage of, nothing stops it dropping the counsel hedge on the fourth answer of a long session, and nothing stops it agreeing to file the EU-CEG notification. This profession is the layer that cannot do those things. Its refusals are what the buyer is purchasing: it will not file, will not give binding legal advice, will not return a flat yes, will not soften a qualification to read more cleanly, and where the research holds no source it returns UNKNOWN and names the primary source to check — because a fabricated citation is not a weaker answer but a negative one, exposing a client to acting on false law in the belief that somebody checked. It does not write the copy either: it emits a constraint object for @di-atomic/copy-engine and @di-atomic/voice-builder, pointedly not linked, because a role that sets the constraint and then writes to it is grading its own homework. The honest limits ship with it. At v0.1.0 it refuses the chemicals half of its own field — REACH, CLP, biocides, SDS, GHS, HS-code — by name, because Di-Atomic's heritage there is real and the skill behind it is not built yet. Priority-2 markets are answered as summary-level or escalated, never as if fully covered. And it does not decide whether a market is worth entering — only what entering it lawfully requires.
What this profession guarantees
Cites, or says it does not know
Every rule in a verdict carries its instrument and a live primary source, gated by a citation verifier that blocks delivery on FAIL. Where the research holds no source the answer is UNKNOWN plus the source to check — never a regulation number that merely looks real.
Checks the calendar before it answers
Several of these markets are lawful today and closed on a near date, and one major EU instrument is in flight rather than in force. The effective-date check runs before the verdict is written, and a scheduled change is stated on the face of the answer.
Classifies per jurisdiction, not per product
The same nicotine pouch is a smokeless tobacco product in one market, a consumer nicotine product in the second and an unlicensed medicine in the third. The rules attach to the class, and the class is decided market by market rather than taken from the label.
Leaves an audit trail as a side effect
Every verdict lands in agentdocs as a new immutable versioned page with its sources, retrieval dates and open items. That record is what a client's counsel or a regulator actually asks for, and it accumulates from asking questions rather than from a project nobody funds.
Will not file, and will not pretend to
EU-CEG, PMTA, MHRA and TGA are operator portals with operator credentials and operator liability. It produces the notification checklist and the documentation set; a human with the account submits.
The craft it carries
Where it operates
Package
- Registry id
- @di-atomic/regulatory-affairs-specialist
- Version
- 0.1.0
- Published by
- Di-Atomic