Gini Loh System Tools

AI Automation Index

Will AI Replace Regulatory Affairs Specialists?

Task-level automation exposure for Regulatory Affairs Specialists: 30 O*NET tasks scored against their work activities, plus the simulator.

E-E-A-T Verified
Developed & audited by Gini Loh

Automation Exposure

67% weighted task index

30 of 30 tasks scored

Median Salary

$80,730 / year

BLS OEWS, May 2025 — this exact occupation

Employment Level

Very High

417,070 people hold this job — size, not growth

Projected 2025–35

+3.8% employment change

32,700 openings a year · BLS line item

Pay by state

BLS OEWS publishes 54 state estimates for this occupation. Each is its own survey estimate, not the national median adjusted for local prices.

$48,950 – $111,030

Highest medians

District of Columbia $111,030
Massachusetts $102,060
New Jersey $100,000
California $96,980
Connecticut $91,810

Lowest medians

Puerto Rico $48,950
Oklahoma $63,000
Tennessee $63,960
West Virginia $64,270
Arkansas $64,680

State figures come from the 13-1041 row in the May 2025 state panel. States where the estimate was suppressed or too small to publish are absent.

What the score is made of

Each task is mapped to its work activities, scored for AI automation potential, and weighted by how important those activities are to the job. These are the components.

Automation potential 67%

Importance-weighted mean of the scored tasks. This is the headline index.

Physical work 0%

Share of weighted tasks in hands-on or machine-operating work activities.

Judgment & influence 60%

Share in analysis, decisions, teaching, directing, advising, or caring for others.

Routine administration 19%

Share in documenting, recording, and administrative activities.

Rewritten by O*NET 0%

Share of weighted tasks O*NET rewrote in a recent update. Reported, not folded into the score.

Consequence of error 11/100 Low

O*NET's own rating of how serious an uncorrectable mistake would be here — respondents, not us. Deliberately not in the index: the score measures what AI can do with the task content, and multiplying it by stakes would be our judgment dressed as data.

Constituent Task Mix

30 tasks for this occupation, weighted by work-activity importance. Shares below are of total task weight, not task count.

High exposure (≥ 60% of the task is automatable) 76%

22 tasks

Medium exposure (≥ 35%) 24%

8 tasks

Low exposure (below 35%) 0%

0 tasks

How would you survive?

Move your week away from the high-exposure tasks and toward the ones that need judgment. The simulator recalculates the index as you shift the mix.

Simulate Upskilling →

Constituent Tasks

#18048 · Core · 71% automatable

Coordinate, prepare, or review regulatory submissions for domestic or international projects.

text generation — Track and draft regulatory documentation; human verifies

Prepare regulatory or compliance documentation. Coordinate regulatory documentation activities.
#18045 · Core · 55% automatable

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

information retrieval — Documentation research aided; formal filing human

Obtain documentation to authorize activities.
#18058 · Core · 80% automatable

Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

information retrieval — AI tracks regulatory changes; human confirms applicability

Update knowledge of legal or regulatory environments.
#18070 · Core · 78% automatable

Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

information retrieval — Product compliance check against regulations, human verifies

Examine product information to ensure compliance with regulations.
#18054 · Core · 72% automatable

Coordinate efforts associated with the preparation of regulatory documents or submissions.

text generation — Track and draft regulatory documentation; human verifies

Coordinate regulatory documentation activities.
#18061 · Core · 72% automatable

Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

text generation — Track and draft regulatory documentation; human verifies

Coordinate regulatory documentation activities.
#18055 · Core · 65% automatable

Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.

information retrieval — Law-to-activity mapping; human owns compliance

Evaluate applicable laws and regulations to determine impact on organizational activities.
#18062 · Core · 70% automatable

Prepare or maintain technical files as necessary to obtain and sustain product approval.

text generation — Draft regulatory docs; human owns compliance

Prepare regulatory or compliance documentation.
#18067 · Core · 40% automatable

Coordinate recall or market withdrawal activities as necessary.

interpersonal — Overseeing business processes requires human accountability

Oversee business processes.
#21095 · Core · 55% automatable

Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.

text generation — Drafting agency communications aided; relationships human

Communicate with government agencies.
#24014 · Core · 63% automatable

Develop regulatory strategies for products.

text generation — Draft regulatory docs; human owns compliance

Develop business or market strategies. Prepare regulatory or compliance documentation.
#21094 · Core · 76% automatable

Identify relevant guidance documents, international standards, or consensus standards.

text generation — Technical documentation compilation, human reviews accuracy

Compile technical information or documentation. Review documents or materials for compliance with policies or regulations. Evaluate applicable laws and regulations to determine impact on organizational activities.
#18052 · Core · 55% automatable

Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.

decision support — Compliance guidance drafted; human verifies and owns

Advise others on legal or regulatory compliance matters.
#18049 · Core · 62% automatable

Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

information retrieval — AI explains policies; human handles live questions

Explain regulations, policies, or procedures.
#18050 · Core · 72% automatable

Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

text generation — Track and draft regulatory documentation; human verifies

Coordinate regulatory documentation activities.
#18051 · Core · 78% automatable

Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.

information retrieval — Product compliance check against regulations, human verifies

Examine product information to ensure compliance with regulations.
#18065 · Core · 65% automatable

Review clinical protocols to ensure collection of data needed for regulatory submissions.

information retrieval — Law-to-activity mapping; human owns compliance

Evaluate applicable laws and regulations to determine impact on organizational activities.
#18060 · Core · 60% automatable

Participate in internal or external audits.

data analysis — Analyzes records and processes; human confirms conclusions

Examine financial records or processes.
#18053 · Core · 85% automatable

Compile and maintain regulatory documentation databases or systems.

data analysis — Enter and maintain data in information systems

Maintain data in information systems or databases.
#18063 · Core · 55% automatable

Recommend changes to company procedures in response to changes in regulations or standards.

decision support — Compliance guidance drafted; human verifies and owns

Advise others on legal or regulatory compliance matters.
#18059 · Core · 80% automatable

Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.

information retrieval — AI tracks regulatory changes; human confirms applicability

Update knowledge of legal or regulatory environments.
#18056 · Core · 55% automatable

Develop or conduct employee regulatory training.

text generation — Procedural training content AI-assisted; delivery human

Train personnel in organizational or compliance procedures.
#18066 · Core · 69% automatable

Write or update standard operating procedures, work instructions, or policies.

text generation — Standard financial documents drafted from data

Establish organizational guidelines or policies. Prepare financial documents.
#18068 · Core · 72% automatable

Develop or track quality metrics.

data analysis — Business indicator dashboards are AI-monitorable with human review

Monitor business indicators.
#18064 · Core · 72% automatable

Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.

text generation — Written correspondence to customers is largely automatable

Correspond with customers to answer questions or resolve complaints.
#21096 · Supplemental · 59% automatable

Recommend adjudication of product complaints.

data analysis — Diagnoses operational problems from data; human acts

Investigate system, equipment, or product failures. Analyze data to identify or resolve operational problems. Recommend changes or corrective procedures.
#19554 · Supplemental · 70% automatable

Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.

information retrieval — Regulation-to-compliance mapping; human verifies

Analyze environmental regulations to ensure organizational compliance.
#19553 · Supplemental · 70% automatable

Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.

information retrieval — Regulation-to-compliance mapping; human verifies

Analyze environmental regulations to ensure organizational compliance.
#19552 · Supplemental · 70% automatable

Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.

information retrieval — Regulation-to-compliance mapping; human verifies

Analyze environmental regulations to ensure organizational compliance.
#18069 · Supplemental · 40% automatable

Direct the collection and preparation of laboratory samples as requested by regulatory agencies.

interpersonal — Overseeing business processes requires human accountability

Oversee business processes.
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Method

How this was scored

  1. 1. Tasks. O*NET task statements for this occupation, from a release whose newest record is dated 08/2026.
  2. 2. Work activities. Each task maps to 1–5 Detailed Work Activities; each activity belongs to one of 41 Generalized Work Activities that O*NET rates for importance (1–5) in this occupation.
  3. 3. Automation potential. Every work activity carries one score for how far current AI can perform it end-to-end. Tasks inherit the mean of their activities.
  4. 4. Weighting. Task weight = 0.35 + 0.65 × (importance − 1)/4, scaled by how often the task is performed and by 0.7 for Supplemental tasks. Importance is the task's own O*NET rating where it exists (18,369 of 18,838 tasks); the rest inherit their work activities' importance. The index is the weighted mean.

Check: across the 910 occupations where O*NET also rates how far machine speed sets the pace, this index moves opposite to it (Spearman ρ = -0.49). The more a job is paced by equipment, the less of its task content AI can address — the relationship you would expect if the scoring is working.

Sources · O*NET 31.0 (task records to 08/2026) · BLS OEWS May 2025 · BLS projections 2025-2035 · rubric v2.1 · tasks for O*NET, not a forecast

See the full method →

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