AI exposure: Regulatory Affairs Specialists
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.
Reading this score
computed46.3% of this occupation's weighted task load is exposed, which puts Regulatory Affairs Specialists at the 84th percentile of 923 occupations. The capability is largely there. Its average task scores 3.1 out of 4 on what a current system can produce, and the frictions that hold other jobs in place are comparatively weak here.
What holds the line here is verification cost. Across this occupation's 30 tasks it averages 2.02 out of 3, the highest of the five friction dimensions. In plain terms, checking the output costs more than producing it. Where an undetected error is expensive, dangerous or irreversible, the economics change. Someone has to verify the work, and verifying can cost as much as doing it. This is the friction most likely to fall as tools for checking improve.
The most exposed thing this job does is Compile and maintain regulatory documentation databases or systems, at 73.3%. The least is Develop or conduct employee regulatory training, at 20.0%. A gap of 53.3% between two parts of the same job is the reason this index publishes at task level. An occupation-wide number would have hidden both.
Within business and financial operations occupations, this one is less exposed than the median of 47.5% across the group's 48 roles, with 27 scoring higher. Being in an exposed family does not make a particular job exposed, and the reverse holds too.
What would move this score. Of 30 tasks, 27 are currently banded exposed, 3 assisted and 0 untouched. For that distribution to shift materially would take a change in who is permitted to sign the work, which is a question for regulators rather than for engineers. The score is re-computed every quarter against a fresh capability reference, and the change is published rather than quietly applied.
Task by task
30 tasks, O*NET 31.0| Task | Exposed | Assisted | Untouched | Importance | Band |
|---|---|---|---|---|---|
| Compile and maintain regulatory documentation databases or systems. | 73.3% | 26.7% | 0.0% | 4.04 | exposed |
| Develop or track quality metrics. | 73.3% | 26.7% | 0.0% | 3.53 | exposed |
| Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. | 73.3% | 26.7% | 0.0% | 3.28 | exposed |
| Identify relevant guidance documents, international standards, or consensus standards. | 53.7% | 29.6% | 16.7% | 4.26 | exposed |
| Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. | 50.0% | 25.0% | 25.0% | 4.65 | exposed |
| Coordinate recall or market withdrawal activities as necessary. | 50.0% | 25.0% | 25.0% | 4.38 | exposed |
| Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. | 50.0% | 25.0% | 25.0% | 3.95 | exposed |
| Direct the collection and preparation of laboratory samples as requested by regulatory agencies. | 50.0% | 25.0% | 25.0% | 3.70 | exposed |
| Write or update standard operating procedures, work instructions, or policies. | 49.6% | 37.9% | 12.5% | 3.61 | exposed |
| Recommend adjudication of product complaints. | 48.3% | 26.7% | 25.0% | 4.07 | exposed |
| Develop regulatory strategies for products. | 47.5% | 27.5% | 25.0% | 4.32 | exposed |
| Coordinate, prepare, or review regulatory submissions for domestic or international projects. | 45.0% | 30.0% | 25.0% | 4.78 | exposed |
| Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. | 45.0% | 30.0% | 25.0% | 4.74 | exposed |
| Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines. | 45.0% | 30.0% | 25.0% | 4.62 | exposed |
| Coordinate efforts associated with the preparation of regulatory documents or submissions. | 45.0% | 30.0% | 25.0% | 4.61 | exposed |
| Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. | 45.0% | 30.0% | 25.0% | 4.61 | exposed |
| Prepare or maintain technical files as necessary to obtain and sustain product approval. | 45.0% | 30.0% | 25.0% | 4.43 | exposed |
| Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. | 45.0% | 30.0% | 25.0% | 4.26 | exposed |
| Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. | 45.0% | 30.0% | 25.0% | 4.22 | exposed |
| Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. | 45.0% | 30.0% | 25.0% | 4.18 | exposed |
| Participate in internal or external audits. | 45.0% | 30.0% | 25.0% | 4.05 | exposed |
| Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. | 40.0% | 35.0% | 25.0% | 4.52 | exposed |
| Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors. | 40.0% | 35.0% | 25.0% | 4.32 | exposed |
| Review clinical protocols to ensure collection of data needed for regulatory submissions. | 40.0% | 35.0% | 25.0% | 4.14 | exposed |
| Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances. | 40.0% | 35.0% | 25.0% | 3.83 | exposed |
| Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste. | 40.0% | 35.0% | 25.0% | 3.80 | exposed |
| Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste. | 40.0% | 35.0% | 25.0% | 3.71 | exposed |
| Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. | 35.0% | 40.0% | 25.0% | 4.26 | assisted |
| Recommend changes to company procedures in response to changes in regulations or standards. | 35.0% | 40.0% | 25.0% | 4.00 | assisted |
| Develop or conduct employee regulatory training. | 20.0% | 30.0% | 50.0% | 3.74 | assisted |
Task text and importance ratings sourced from O*NET 31.0. Shares computed. The occupation score is the importance-weighted mean.
Where the score comes from
judgedEvery task is scored through the standardised work activities it maps to. These are this occupation’s averages on the six rubric dimensions. Capability is what AI can do; the other five are what stands in the way.
| Dimension | Mean | Scale |
|---|---|---|
| Capability | 3.09 | 0-4 |
| Embodiment | 0.09 | 0-3 |
| Presence | 0.26 | 0-3 |
| Accountability | 1.75 | 0-3 |
| Context | 1.93 | 0-3 |
| Verification cost | 2.02 | 0-3 |
What this means in practice
Where most of a role's weighted task load is exposed, the work that survives is usually the part of the job nobody wrote into the job description: deciding what should be produced rather than producing it, and being answerable for the result. The tasks lowest on this page are a better guide to where to spend your time than any general advice about the future of work.
Occupations either side of this one
The four closest scores in the same occupational family, then the four closest anywhere in the index.
Read this carefully. Exposure is not displacement. A high score means current AI systems can produce this work, not that anyone will stop paying a person to do it. Adoption depends on economics, regulation and inertia that this index deliberately does not model. How the score is built.