AI exposure by occupation, O*NET 13-1041.07

Will AI replace Regulatory Affairs Specialists?

Regulatory Affairs Specialists: AI can already handle 9 of 30 tasks; the work mostly needs a standard-tier model.

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Every task, scored

The 30 tasks O*NET 30.3 lists for Regulatory Affairs Specialists, from most to least exposed. 9 reach 60 or more, the level at which AI already handles a task.

Task AI exposure Evidence Model tier Importance
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. 90 Estimated Standard 4.4
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. 90 Estimated Standard 4.3
Compile and maintain regulatory documentation databases or systems. 80 Estimated Standard 3.8
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. 65 Estimated Efficient 4.5
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. 65 Estimated Standard 4.4
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines. 65 Estimated Standard 4.3
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. 65 Estimated Frontier 4.2
Review clinical protocols to ensure collection of data needed for regulatory submissions. 65 Estimated Standard 4.0
Recommend adjudication of product complaints. 60 Estimated Efficient 3.2
Coordinate efforts associated with the preparation of regulatory documents or submissions. 50 Estimated Frontier 4.6
Coordinate recall or market withdrawal activities as necessary. 50 Estimated Frontier 4.4
Develop or track quality metrics. 50 Estimated Standard 3.3
Develop or conduct employee regulatory training. 50 Estimated Standard 3.2
Coordinate, prepare, or review regulatory submissions for domestic or international projects. 40 Observed Efficient 4.5
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. 40 Observed Standard 4.3
Identify relevant guidance documents, international standards, or consensus standards. 40 Observed Efficient 4.3
Recommend changes to company procedures in response to changes in regulations or standards. 40 Observed Efficient 4.0
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. 30 Estimated Standard 4.5
Participate in internal or external audits. 30 Estimated Efficient 3.8
Write or update standard operating procedures, work instructions, or policies. 30 Estimated Standard 3.5
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. 30 Estimated Efficient 3.5
Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste. 30 Estimated Efficient 3.3
Direct the collection and preparation of laboratory samples as requested by regulatory agencies. 30 Estimated Standard 3.2
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. 30 Estimated Efficient 2.9
Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops. 30 Estimated Efficient 2.4
Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste. 30 Estimated Efficient 2.3
Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances. 30 Estimated Efficient 2.2
Prepare or maintain technical files as necessary to obtain and sustain product approval. 20 Estimated Efficient 4.5
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. 20 Estimated Efficient 4.0
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors. 20 Estimated Efficient 4.0

Observed: scored from AI use recorded in the Anthropic Economic Index (June 2026 release), 4 of 30 tasks. Estimated: scored from the task's O*NET 30.3 work activity, 26 of 30. Importance is O*NET's 1 to 5 rating of how central the task is. Model tier is the lowest tier that can do the task under the published rubric; "No tier" marks hands-on work.

The model tier this role needs

A standard-tier model or lower covers 88% of the role's importance-weighted task work. 100% of the work is something AI can address at some tier.

Efficient, standard and frontier tiers come from the JobRoute model tier reference. The recommended tier is the lowest one that covers 80% of the work AI can address. How the method works.

Wages, employment and outlook

US employment
417,070
Median annual wage
$80,730
Middle half of earners
$61,280 to $109,010
Projected change, 2024 to 2034
+3.0%

Employment and wages: BLS Occupational Employment and Wage Statistics, May 2025, national. Projection: BLS Employment Projections 2024 to 2034. BLS publishes these figures by SOC code, so O*NET occupations that share a SOC code show the same figures.

Adjacent roles

The occupations that reuse the most of this role's skills, with the usual time to move. These are the first places to look when you plan to redeploy or retrain people in this role.

Skill overlap and transition time from the JobRoute role adjacency graph on O*NET 30.3 skills.

Questions about Regulatory Affairs Specialists and AI

Will AI replace Regulatory Affairs Specialists?

AI already handles 9 of the 30 tasks O*NET lists for this occupation, at a task exposure of 60 or more, and the role's importance-weighted exposure is 47 out of 100. JobRoute scores tasks, not whole jobs, so the score shows how much of the work changes rather than whether the job disappears. BLS projects employment to change by +3.0% from 2024 to 2034.

What is the AI exposure of Regulatory Affairs Specialists?

47 out of 100 on JobRoute's task exposure measure, the importance-weighted average of the role's O*NET task scores. Higher means more of the work is AI-doable today. 4 of the 30 task scores are observed in the Anthropic Economic Index (June 2026 release), and the other 26 are estimated from each task's O*NET work activity.

Which Regulatory Affairs Specialists tasks can AI already do?

The tasks with the highest exposure are: Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes; Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies; Compile and maintain regulatory documentation databases or systems. They are three of the 9 tasks that reach 60 or more.

What AI model tier does this role need?

A standard-tier model or lower covers 88% of the role's importance-weighted task work. JobRoute assigns each task the lowest tier that can do it under a published rubric and recommends the lowest tier that covers 80% of the work AI can address.

How many people work as Regulatory Affairs Specialists, and what do they earn?

417,070 people in the United States, with a median annual wage of $80,730 (BLS Occupational Employment and Wage Statistics, May 2025). BLS Employment Projections expect a change of +3.0% from 2024 to 2034.

How to cite

Data version 2026-11-02, JobRoute method v1.0.0. Download all occupations or this occupation as JSON. Methodology.

JobRoute (2026). AI exposure: Regulatory Affairs Specialists. Data version 2026-11-02, method v1.0.0. Built on O*NET 30.3, BLS OEWS May 2025 and the Anthropic Economic Index (June 2026). CC BY 4.0. https://www.jobroute.ai/jobs/regulatory-affairs-specialists

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