Will AI replace Regulatory Affairs Managers?

Many of your tasks are within reach of AI. The role will change, so it pays to act now.

Task exposure to today's AI

52/100

High exposure

This is the occupation's typical task mix. Your own score can be up to 30 points higher or lower depending on how you work: routine share, people contact, judgment and how much you already use AI.

Get your personal score

Will AI replace Regulatory Affairs Managers?

Not entirely. Today's AI tools can take on about 52% of the typical work in this occupation, mostly: maintain current knowledge of relevant regulations, including proposed and final rules. The parts that stay human include: Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.; Direct the preparation and submission of regulatory agency applications, reports, or correspondence.; Develop regulatory strategies and implementation plans for the preparation and submission of new products..

People who learn to use AI for the automatable parts keep the edge. The 3-phase plan below shows where to start.

Which tasks AI can take on

The largest tasks in this occupation, their share of the working week, and how much of each today's AI tools can do.

TaskAutomatable

Maintain current knowledge of relevant regulations, including proposed and final rules. 62%

Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.AI already used 60%

Direct the preparation and submission of regulatory agency applications, reports, or correspondence. 57%

Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.AI already used 55%

Develop regulatory strategies and implementation plans for the preparation and submission of new products. 50%

Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. 45%

+ 21 more tasks (52% of the week) in the full test.

Your human edge

Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
Develop regulatory strategies and implementation plans for the preparation and submission of new products.

AI tools to try

ChatGPT / Claude for drafts and analysisMicrosoft 365 Copilot or Google Gemini for WorkspaceMeeting assistants (e.g. Otter, Fireflies)

Related roles

A 3-phase AI learning plan

Phase 1

AI for the admin load

Meeting notes, summaries and follow-ups with AI.
First drafts of reports, plans and emails.
Spreadsheet analysis with AI (formulas, charts, explanations).

Project

Use AI to transcribe and summarise four weeks of regulatory project meetings into action logs and draft follow-up emails to R&D and QA, and log hours saved per meeting.

Phase 2

Decisions with better input

Use AI to research options and summarise sources, then check them.
Scenario and risk analysis with AI as a sparring partner.
Set team rules for what may and may not go into AI tools.

Project

Have AI summarise public guidance documents for one new product's market pathway, verify every citation against the agency source, and draft a two-page regulatory strategy with three scenarios.

Phase 3

Lead the change

Map which team tasks AI can take over or speed up.
Run a small pilot and measure time and quality.
Plan training and new roles for your team.

Project

Map your team's submission tasks by AI suitability, pilot AI-assisted drafting and compliance review of one module for 3 weeks, and report time saved and error counts versus baseline.

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