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Regulatory Affairs Specialists

Regulatory Affairs Specialists score 54 out of 100, which is elevated exposure to AI. That ranks #156 of 923 US occupations, where #1 is the most exposed. Of the 32 tasks in this job, AI could speed up 3 on its own and 28 more with extra software built on top of it. In April–May 2026, 13 of these tasks showed up in real conversations with Claude, Anthropic's AI assistant.

54/ 100
Elevated
Rank
#156of 923 jobs
US workers
417,070for Compliance Officers
Median pay
$80,730a year
In real AI use
13 of 32tasks, April–May 2026

Task by task

Each task this job involves, as listed by O*NET, rated on whether a large language model like GPT-4 could cut the time it takes by at least half at the same quality. Tasks marked Seen in real AI use appeared in conversations with Claude in April–May 2026 (Anthropic Economic Index).

  • AI can speed this up on its own: 3 (9%)
  • AI can speed this up with extra software: 28 (88%)
  • Little or no AI speed-up: 1 (3%)
  • Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.AI can speed this up on its own · core task
  • Write or update standard operating procedures, work instructions, or policies.AI can speed this up on its own · core task · Seen in real AI use
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.AI can speed this up on its own · supplemental task · Seen in real AI use
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.AI can speed this up with extra software · core task
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.AI can speed this up with extra software · core task
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.AI can speed this up with extra software · core task
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.AI can speed this up with extra software · core task · Seen in real AI use
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.AI can speed this up with extra software · core task · Seen in real AI use
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.AI can speed this up with extra software · core task · Seen in real AI use
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.AI can speed this up with extra software · core task
  • Coordinate recall or market withdrawal activities as necessary.AI can speed this up with extra software · core task
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.AI can speed this up with extra software · core task · Seen in real AI use
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.AI can speed this up with extra software · core task
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.AI can speed this up with extra software · core task · Seen in real AI use
  • Identify relevant guidance documents, international standards, or consensus standards.AI can speed this up with extra software · core task · Seen in real AI use
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.AI can speed this up with extra software · core task
  • Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.AI can speed this up with extra software · core task
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.AI can speed this up with extra software · core task
  • Recommend changes to company procedures in response to changes in regulations or standards.AI can speed this up with extra software · core task · Seen in real AI use
  • Participate in internal or external audits.AI can speed this up with extra software · core task · Seen in real AI use
  • Compile and maintain regulatory documentation databases or systems.AI can speed this up with extra software · core task · Seen in real AI use
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.AI can speed this up with extra software · core task
  • Develop or track quality metrics.AI can speed this up with extra software · core task · Seen in real AI use
  • Develop or conduct employee regulatory training.AI can speed this up with extra software · core task
  • Recommend adjudication of product complaints.AI can speed this up with extra software · core task · Seen in real AI use
  • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.AI can speed this up with extra software · supplemental task
  • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.AI can speed this up with extra software · supplemental task
  • Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.AI can speed this up with extra software · supplemental task
  • Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.AI can speed this up with extra software · supplemental task
  • Obtain clearances for the use of recycled plastics in product packaging.AI can speed this up with extra software · supplemental task
  • Monitor national or international legislation on ozone-depleting substances or global warming.AI can speed this up with extra software · supplemental task
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.Little or no AI speed-up · supplemental task

Similar jobs, lower exposure

Related occupations that score at least 10 points lower.

Other jobs in this field

Business and Financial Operations occupations close to this one.

Questions about regulatory affairs specialists and AI

Will AI replace regulatory affairs specialists?

Not entirely. Parts of the job are likely to change as AI takes over routine tasks. Regulatory Affairs Specialists score 54 out of 100 (elevated exposure), #156 of 923 US jobs. AI could speed up 31 of the job's 32 tasks, 3 of them on its own, while 1 see little or no speed-up. Exposure means the work is likely to change, not that the job will disappear.

Which regulatory affairs specialists tasks can AI do?

The most exposed tasks include "Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation"; "Write or update standard operating procedures, work instructions, or policies"; "Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires".

Which regulatory affairs specialists tasks are hardest for AI?

Tasks with little or no AI speed-up include "Direct the collection and preparation of laboratory samples as requested by regulatory agencies".

Are people already using AI for this work?

Yes. In April–May 2026, 13 of the 32 tasks showed up in real conversations with Claude, according to the Anthropic Economic Index.

How many people work as regulatory affairs specialists, and what do they earn?

About 417,070 people in the US (figure for Compliance Officers), with median pay of $80,730 a year (BLS, May 2025).

How to read this score. Exposure measures how much of the work AI could speed up, not whether the job will disappear. A highly exposed job can change shape, with people spending less time on routine tasks and more on the rest. The score counts tasks AI can speed up on its own in full, and tasks that need extra software at half weight.

The ratings come from published research based on GPT-4 (2023). To show what's happening now, each task is also checked against the latest Anthropic Economic Index, which records which tasks people actually use AI for. That data is refreshed automatically when Anthropic publishes a new release. Read the full method.

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