The Standard · Legal, Risk and Compliance

Regulatory Affairs

Tracks and interprets regulation with AI and verifies every citation before relying on it.

You track guidance, interpret requirements, and prepare accurate submissions, responses, and compliance documents. An AI assistant extends searches and comparisons, but can invent citations, miss changes, or misread authority requirements.

The exam for Regulatory Affairs is not open yet. A skill opens once its questions are approved and tested.

What it measures

Whatever the skill, the exam rates your work in the same six areas of the Standard. Three are for the value you get from the assistant, and three for the control you keep. Each area gets one of 4 ratings (Emerging, Developing, Proficient, Accomplished). For Regulatory Affairs, a strong performance looks like this. What each area includes and excludes.

Value

What you get from the assistant: how far it takes the work, how well you brief it, and the piece you hand in.

Reaching further

You use the reply to reveal overlooked requirements, guidance changes, authority questions, and alternatives for the regulatory reader.

Using the assistant to produce work beyond what you could have produced alone, rather than the same work faster.

Briefing the assistant

You brief the assistant with the regulatory audience, purpose, source requirements, citation standard, format, and required coverage.

Giving the assistant the reader, purpose and source facts the work depends on, and the form, length and contents you need back.

The finished piece

You turn the reply into precise, neutral regulatory prose, adding traceable reasoning and adapting it for its audience.

Turning the assistant's output into something a colleague could use: editing it, combining it and adding original thinking.

Control

What you keep in hand: checking its work, keeping information safe, and deciding what stays with a person.

Checking its work

You check each regulatory claim, citation, date, and interpretation against the governing source before relying on the work.

Checking the assistant's claims, figures and assumptions against the source before the work is used.

Safety and confidentiality

You keep confidential trial, patient, and commercially restricted information out of the brief and delivered regulatory text.

Handling confidential and personal data, seeing compliance, ethical and reputational risk, and declining unsafe requests.

Knowing what to delegate

You keep submission-critical judgements with people, state confirmed facts, and name approvers for open regulatory decisions.

Deciding what to hand to the assistant and what to keep, and at what stakes, before any output exists.

What you do in the exam

Every skill of the Standard is examined the same way, at the same pass mark, in the Applied AI Badge. Two tasks with the assistant and two sets of questions, over 15 minutes. You do real work with an AI assistant beside you, hand in what you would send, then answer follow-up questions about your own work.

  1. 01

    A requirements matrix from guidance documents and submission evidence.

  2. 02

    A response draft from a deficiency letter and verified source material.

  3. 03

    A citation-checked regulatory document from supplied source requirements.

These are the kinds of task the exam sets. Your exam draws its own from a bank the Examination Board has approved.

Price
US$19
Length
15 minutes
Attempts
One for each purchase, then a 7-day wait

What the badge certifies

What an employer reads

Passed an Institute exam in regulatory affairs. They briefed the assistant with requirements and citation rules, caught unsupported claims, and delivered a traceable submission section.

You earn it in one exam, never by finishing a course.

Name on the certificate
Applied AI Badge: Regulatory Affairs
Who it is for
Regulatory affairs specialists, managers, and submission leads who verify regulated content with AI.
Valid for
2 years, then renew
Verification
Every badge has a public verification page an employer can open, and a place in the public register if you choose it.
Marked by
An AI examiner marks your work against a marking guide and quotes your own words as evidence. A person checks anything borderline.

Near it in the Standard

  • Document Review

    Reviews documents with AI at scale and catches what the tool misses or invents.

    Practice only

  • Risk Management

    Identifies and weighs risks with AI's help and owns the call on each one.

  • Ethical AI Use in Practice

    Applies AI ethically in practice: consent, fairness, transparency and knowing when not to use it.

  • Contract Review

    Reviews contracts with AI, confirms every clause against the text and escalates what matters.

  • ESG & Sustainability Reporting

    Prepares ESG and sustainability reporting with AI, with every metric evidenced.

  • Quality Assurance

    Uses AI in quality assurance to find defects and never to sign off on its own.

  • Monitoring & Evaluation

    Designs monitoring and evaluation with AI and validates indicators against real data.

Everything in Legal, Risk and Compliance, including the level exams that name the whole function.

Practise it before you pay for it

Practice is free (up to 50 sessions a day) and shaped like the exam, with a coach that tells you what to change. It never counts towards a credential, and an exercise you practised is kept out of your exam.

How practice worksTake the free AI skills exam

Want to learn it first? AI+ Regulatory Affairs covers this skill. No book is required to pass.