Will AI replace Regulatory Affairs Specialists?
AI reaches most of this job’s work.
68/100
Very high exposure
More exposed to AI than 96% of US workers.
- AI already used in
- 9% of the work
- As AI tools mature: up to
- 91% of the work
What the job involves
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.
Where AI reaches the work
The job’s main tasks, heaviest first, by how far AI reaches them.
Already happening(3)
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
Within reach(23)
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
and 18 more
Out of reach(3)
- Coordinate recall or market withdrawal activities as necessary.
- Develop or conduct employee regulatory training.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
Also called
Regulatory Specialist · QA Specialist (Quality Assurance Specialist) · RA Associate (Regulatory Affairs Associate) · Regulatory Consultant · QA Specialist · RA Associate · Drug Regulatory Affairs Specialist · RA Analyst (Regulatory Affairs Analyst)
Related jobs
What these numbers mean
The score is the share of this job’s work, weighted by how important and frequent each task is, that AI could do in half the time: tasks an AI model could do alone count in full, tasks that need software built on AI count half.
“AI already used” is the share of the work in tasks where people are recorded using AI today. “As AI tools mature” counts every task AI could halve, with or without extra software.
The percentile compares the score with every job’s, weighted by how many people in the US do each one. Exposure means AI could change how the work is done, not that the job goes away. These are estimates for the typical job, not predictions.
Sources
- O*NET 31.0 Database, U.S. Department of Labor, Employment and Training Administration
- GPTs are GPTs: Labor market impact potential of LLMs (task labels), Eloundou, Manning, Mishkin & Rock (2023), OpenAI and University of Pennsylvania
- Anthropic Economic Index: labor market impacts (task penetration), Anthropic
- Occupational Employment and Wage Statistics, May 2025 (national and metropolitan areas), U.S. Bureau of Labor Statistics