Will regulatory affairs managers be replaced by AI?
Updated
Regulatory affairs managers score 50 of 100 for AI exposure. The largest share of their task time, 75%, is work AI speeds up while they stay in charge. AI can take over 14% outright, and 11% stays with people.
- 14% AI can do it
- 75% AI helps
- 11% Needs a person
High exposure
Higher than 75% of the 923 occupations we scored.
Task by task
We graded 27 tasks, listed here from most to least exposed. AI can do 4 of them today, speeds up 20 and leaves 3 to people.
| Task | AI exposure |
|---|---|
| Maintain current knowledge of relevant regulations, including proposed and final rules. AI monitors and summarizes rule changes; person reviews impact. | 65% AI can do it |
| Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met. AI screens marketing and manual text against regulatory requirements. | 65% AI can do it |
| Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. AI checks submissions against checklists; expert signs off. | 60% AI helps |
| Develop and maintain standard operating procedures or local working practices. AI drafts SOPs well; approval and local fit need people. | 60% AI helps |
| Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes. AI scans and summarizes industry regulatory trends; person reviews impact. | 60% AI can do it |
| Monitor regulatory affairs trends related to environmental issues. AI monitors environmental regulatory trends and summarizes changes. | 60% AI can do it |
| Direct the preparation and submission of regulatory agency applications, reports, or correspondence. AI drafts applications and reports; manager directs and approves. | 50% AI helps |
| Provide responses to regulatory agencies regarding product information or issues. AI drafts agency responses; accountable person reviews and sends. | 50% AI helps |
| Direct documentation efforts to ensure compliance with domestic and international regulations and standards. AI drafts and checks compliance documents; manager oversees content. | 50% AI helps |
| Develop regulatory strategies and implementation plans for the preparation and submission of new products. AI drafts strategy options; lead still is responsible for submission decisions. | 45% AI helps |
Show the other 17 tasks
| Task | AI exposure |
|---|---|
| Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. AI drafts briefings and summaries; checking understanding needs people. | 45% AI helps |
| Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. AI drafts policies and procedures; leadership approves and implements. | 45% AI helps |
| Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary. AI triages complaints and drafts reports; investigation needs people. | 40% AI helps |
| Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. AI answers routine guidance questions; teams need expert judgment. | 40% AI helps |
| Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations. AI monitors complaint queues and trends; resolution needs investigators. | 40% AI helps |
| Train staff in regulatory policies or procedures. AI builds training content and Q&A; delivery needs a person. | 40% AI helps |
| Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives. AI tracks activities and flags sustainability gaps; people decide. | 40% AI helps |
| Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation. AI analyzes chemical and carbon data; expert judgment validates results. | 40% AI helps |
| Participate in the development or implementation of clinical trial protocols. AI drafts protocol sections; clinical judgment stays with experts. | 35% AI helps |
| Establish procedures or systems for publishing document submissions in hardcopy or electronic formats. Publishing tools automate formatting; setup and QC need people. | 35% AI helps |
| Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions. AI researches software options; agency talks and selection stay human. | 35% AI helps |
| Contribute to the development or implementation of business unit strategic and operating plans. AI helps draft plan sections; strategy choices need executives. | 30% AI helps |
| Coordinate internal discoveries and depositions with legal department staff. AI helps sort discovery documents; depositions and legal coordination need people. | 30% AI helps |
| Manage activities such as audits, regulatory agency inspections, or product recalls. AI helps prep audit documents and tracking; inspections stay in person. | 25% AI helps |
| Establish regulatory priorities or budgets and allocate resources and workloads. Priorities and budget allocation rest on leadership judgment and tradeoffs. | 18% Needs a person |
| Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. Live representation and negotiation with agencies needs human presence. | 15% Needs a person |
| Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations. Building agency relationships depends on in-person trust and dialogue. | 10% Needs a person |
How regulatory affairs managers compare
All occupations (923)
Management (56)
Pay and outlook in the US
- Median pay
- $141,900 a year, May 2025
- People employed
- 103,698 in the US, May 2025
- Projected change in jobs
- +4.9% from 2024 to 2034
Skills to build
- Run impact reviews on proposed and final rule changes
- Sign off submissions that AI has checked against agency checklists
- Write and approve SOPs in Microsoft Word and SharePoint
- Lead agency meetings and negotiations in person
- Hold the RAPS Regulatory Affairs Certification (RAC)
- Manage audit and inspection readiness in Microsoft Project
Safer roles nearby
5 related occupations with lower scores.
Questions about regulatory affairs managers and AI
Will AI replace regulatory affairs managers?
Partly. About 4 in 10 working hours go to tasks AI can already do, mostly keeping up with regulations and reviewing marketing literature and user manuals against agency requirements. What stays with people is signing off submissions, negotiating with agencies, and deciding priorities and budgets.
Which tasks is AI taking over for regulatory affairs managers?
AI takes over rule monitoring and first pass document screening. Keeping up with proposed and final rules scores 65 on exposure, so AI tracks changes and summarizes them while a person reviews the impact on the business. Checking marketing literature and user manuals against agency requirements also scores 65, because that text follows fixed rules a model can match.
Which tasks stay human for regulatory affairs managers?
Agency relationships, live representation, and budget decisions stay with people. Building trust with state and federal environmental agencies depends on in-person dialogue, and representing a company before regulators on major policy matters needs a person in the room. Setting priorities and allocating budgets rests on leadership judgment and tradeoffs.
How do regulatory affairs managers stay valuable?
Take responsibility for the review and sign off step on every AI drafted output. Check AI screened submissions against agency checklists before signing, and adapt SOP drafts to local working practice in SharePoint. Put the hours freed from rule monitoring into agency meetings and audit readiness tracked in Microsoft Project.
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