Will AI replace Regulatory Affairs Managers?

AI can do 90% of the work Regulatory Affairs Managers do at least twice as fast. People already use it for 4 of their 27 tasks, while 20 more are ready but barely used so far. 3 still need a person.

AI is already doing this4 · 26% of time

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

  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.Mostly automated10% of time
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.Mostly automated8% of time
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.Mostly automated5% of time
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.Mostly automated3% of time

AI could do this next20 · 64% of time

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

  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.10% of time
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.8% of time
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.6% of time
  • Maintain current knowledge of relevant regulations, including proposed and final rules.6% of time
  • Provide responses to regulatory agencies regarding product information or issues.5% of time
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.3% of time
  • Establish regulatory priorities or budgets and allocate resources and workloads.3% of time
  • Develop and maintain standard operating procedures or local working practices.3% of time
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.2% of time
  • Participate in the development or implementation of clinical trial protocols.2% of time
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.2% of time
  • Train staff in regulatory policies or procedures.2% of time
  • Contribute to the development or implementation of business unit strategic and operating plans.2% of time
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.1% of time
  • Coordinate internal discoveries and depositions with legal department staff.1% of time
  • Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.1% of time
  • Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.1% of time
  • Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.1% of time
  • Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.1% of time
  • Monitor regulatory affairs trends related to environmental issues.1% of time

Still needs a person3 · 10% 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.

  • Manage activities such as audits, regulatory agency inspections, or product recalls.5% of time
  • Direct documentation efforts to ensure compliance with domestic and international regulations and standards.5% of time
  • Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.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 24 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 4 tasks AI is already handling with AI yourself. Your peers already are, and it is quickly becoming the baseline.
  • Get ahead on the 20 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.
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