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How exposed to AI is a Regulatory Affairs Specialist?

Of the 32 tasks O*NET lists for regulatory affairs specialists, 13 could be done in half the time with a chat window today. 3 cannot be sped up at all. Here is which.

Exposure means published research judged an AI could halve the time a task takes, at the same quality. It does not mean the task stops needing a person. How to read this

Also called
Drug Regulatory Affairs SpecialistRegulatory Affairs Analyst (RA Analyst)Regulatory Affairs Associate (RA Associate)Regulatory Affairs Consultant (RA Consultant)Regulatory Affairs Specialist (RA Specialist)Regulatory Affairs Strategist (RA Strategist)Regulatory EngineerRegulatory Services ConsultantRegulatory SpecialistRegulatory Submissions Associate
Reachable today Needs software built first Cannot be sped up
32
tasks rated for this occupation
100%
hold a degree, from a survey of 20
334k
people do this job in the US
11 of 48
least protected in business and finance

Every task, and what AI can do with it

These are O*NET's task statements for this occupation, exactly as written, sorted into the three bands by the ratings behind this report. Nothing has been reworded.

Reachable with a chat window today

13
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
  • Prepare or maintain technical files as necessary to obtain and sustain product approval
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies
  • Identify relevant guidance documents, international standards, or consensus standards
  • Review clinical protocols to ensure collection of data needed for regulatory submissions
  • Recommend changes to company procedures in response to changes in regulations or standards
  • Compile and maintain regulatory documentation databases or systems
  • 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
  • Obtain clearances for the use of recycled plastics in product packaging

Only with software built on top

16
  • 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
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines
  • Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
  • Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
  • Participate in internal or external audits
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards
  • Develop or track quality metrics
  • Recommend adjudication of product complaints
  • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste
  • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops
  • Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste
  • Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances
  • Monitor national or international legislation on ozone-depleting substances or global warming

Cannot be sped up

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
What this does not say

This is not a prediction about your job

Nobody surveyed an employer. Tasks are counted equally, so a percentage here is a share of the list rather than a share of your week. And the ratings were made in 2023, which makes every figure a floor rather than a ceiling.

It must never be used to select anyone for redundancy. The full limits are here.

Where to go next

This is the standard task list for the title. The useful next question is which of the tasks you actually do should go near AI, and which should not.

Sort your own tasks Read the full report

Exposure ratings from Eloundou, Manning, Mishkin and Rock, GPTs are GPTs: Labor market impact potential of LLMs, Science 384, 1306–1308, 2024, used under the MIT licence. This page includes information from the O*NET Database by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. O*NET® is a trademark of USDOL/ETA. People Team AI has modified all or some of this information. USDOL/ETA has not approved, endorsed, or tested these modifications. Employment figures from the US Bureau of Labor Statistics.