Will AI replace Regulatory Affairs Specialists?

AI can do 97% of the work Regulatory Affairs Specialists do at least twice as fast. People already use it for 3 of their 30 tasks, while 24 more are ready but barely used so far. 3 still need a person.

AI is already doing this3 · 9% of time

People already use AI for these tasks in real work, based on Anthropic's analysis of how Claude is used.

  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.Mostly automated4% of time
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.Mostly automated3% of time
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.Mostly automated3% of time

AI could do this next24 · 88% of time

AI can speed these up by at least half, but real use has not caught up yet. These are next in line.

  • Coordinate efforts associated with the preparation of regulatory documents or submissions.13% of time
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.10% of time
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.6% of time
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.5% of time
  • Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.5% of time
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.5% of time
  • Compile and maintain regulatory documentation databases or systems.5% of time
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.5% of time
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.5% of time
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.4% of time
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.4% of time
  • Write or update standard operating procedures, work instructions, or policies.4% of time
  • Participate in internal or external audits.3% of time
  • Recommend changes to company procedures in response to changes in regulations or standards.3% of time
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.3% of time
  • Identify relevant guidance documents, international standards, or consensus standards.3% of time
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.1% of time
  • Develop or track quality metrics.1% of time
  • Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.1% of time
  • Recommend adjudication of product complaints.1% of time
  • Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.under 1% of time
  • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.under 1% of time
  • Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.under 1% of time
  • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.under 1% of time

Still needs a person3 · 3% of time

No real AI use, no proven AI speedup and no robot that can do it yet. This is the part of the job to build on.

  • Develop or conduct employee regulatory training.1% of time
  • Coordinate recall or market withdrawal activities as necessary.1% of time
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.under 1% of time

Your week is not the average

Describe what you actually do and get a personal report: your own tasks, what AI can already do, what stays yours and a 90 day plan.

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What this means

AI can already do almost all of this work at least twice as fast. Real use is still behind at 8 out of 100, so the change here is only getting started. Expect the role to shift toward deciding what to do, checking AI's work and owning the result.

What to do next

  • Do the 3 tasks AI is already handling with AI yourself. Your peers already are, and it is quickly becoming the baseline.
  • Get ahead on the 24 tasks AI could do next. These move as tools improve, so learning them early pays off.
  • Build on the 3 tasks that stay human. This is where your judgment, skill and relationships matter most.
Compliance Officers81%Environmental Compliance Inspectors67%Equal Opportunity Representatives and Officers73%Government Property Inspectors and Investigators68%Coroners61%Customs Brokers96%

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