Will AI replace regulatory affairs managers?

AI already handles some of this work on its own in real use, for tasks like “Review all regulatory agency submission materials to ensure timeliness”. That's 2h 5m of a typical shift; 5h 55m still has no AI or robot evidence. BLS expects about 4.9% more of these jobs by 2035.

Time card for regulatory affairs managers showing a typical 8-hour shift: 5h 55m done by people, 2h 5m by AI.
Each mark is 5 minutes of a typical shift for regulatory affairs managers, colored by who does that task today. Estimates from O*NET tasks and Anthropic Economic Index data. How it's made

Home / Management / Regulatory Affairs Managers

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Time card

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MineTask, by time spentHumanWith AIAIRobot
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.49m a shift · Observed in AI useTypical AI request: about 8h 8m alone, 37m with AI
Why this label?Marked AI because this task shows up regularly in real AI conversations (Anthropic Economic Index, 2025 usage), and in most of them AI does the task on its own rather than helping a person. Many workplaces may not use AI for it at all. How labels work
Direct the preparation and submission of regulatory agency applications, reports, or correspondence.49m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Develop regulatory strategies and implementation plans for the preparation and submission of new products.38m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.38m a shift · Observed in AI useTypical AI request: about 7h 28m alone, 43m with AI
Why this label?Marked AI because this task shows up regularly in real AI conversations (Anthropic Economic Index, 2025 usage), and in most of them AI does the task on its own rather than helping a person. Many workplaces may not use AI for it at all. How labels work
Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.27m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Maintain current knowledge of relevant regulations, including proposed and final rules.27m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Provide responses to regulatory agencies regarding product information or issues.22m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Manage activities such as audits, regulatory agency inspections, or product recalls.22m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Direct documentation efforts to ensure compliance with domestic and international regulations and standards.22m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.22m a shift · Observed in AI use
Why this label?Marked AI because this task shows up regularly in real AI conversations (Anthropic Economic Index, 2025 usage), and in most of them AI does the task on its own rather than helping a person. Many workplaces may not use AI for it at all. How labels work
Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.16m a shift · Observed in AI use
Why this label?Marked AI because this task shows up regularly in real AI conversations (Anthropic Economic Index, 2025 usage), and in most of them AI does the task on its own rather than helping a person. Many workplaces may not use AI for it at all. How labels work
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.16m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Establish regulatory priorities or budgets and allocate resources and workloads.16m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Develop and maintain standard operating procedures or local working practices.16m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.11m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Participate in the development or implementation of clinical trial protocols.11m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Train staff in regulatory policies or procedures.11m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Contribute to the development or implementation of business unit strategic and operating plans.11m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.11m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.5m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.5m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.5m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Coordinate internal discoveries and depositions with legal department staff.5m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.5m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Monitor regulatory affairs trends related to environmental issues.5m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.5m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work
Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.5m a shift · No AI or robot evidence found
Why this label?No AI use or robot deployment showed up for this task in our data. That isn't proof it's safe; it may just be rare in the data. How labels work

Clock history

  1. 2h 5m touchedFirst published: O*NET 30.1, Anthropic Economic Index (2025 usage and September 2026 robot study), BLS May 2025

When new data changes this clock, the date, the new numbers and the reason are logged here. Company news alone never moves the clock.

On the floor

  1. Rolling outU.S. Food and Drug Administration
    FDA launches agencywide generative AI tool Elsa for reviewers

    The FDA rolled out Elsa weeks ahead of schedule to help review clinical protocols, summarize adverse events and generate database code. The agency said the tool is not trained on data submitted by drug and device makers.

    Axios

Ask the clock

Will AI replace regulatory affairs managers?

Some tasks are already being done by AI or machines; the rest still needs a person. About 2h 5m of a typical shift is made up of tasks that AI or robots have done on their own in real use somewhere. That doesn't mean those hours are automated in a typical workplace. The other 5h 55m (74%) stays with people. Separately, BLS expects about 4.9% more of these jobs by 2035 (all jobs: +3.5%).

What can AI already do for regulatory affairs managers?

AI shows up regularly in 4 of 27 tasks, about 2h 5m of a typical shift. The biggest ones:

  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. (49m a shift, AI mostly does it alone)
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. (38m a shift, AI mostly does it alone)
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met. (22m a shift, AI mostly does it alone)
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary. (16m a shift, AI mostly does it alone)
What still needs a person?

5h 55m of a typical shift, or 74%, goes to tasks with no AI or robot evidence yet. No AI usage or robot deployment has shown up for these so far. The biggest:

  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence. (49m a shift)
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products. (38m a shift)
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. (27m a shift)
  • Maintain current knowledge of relevant regulations, including proposed and final rules. (27m a shift)
  • Provide responses to regulatory agencies regarding product information or issues. (22m a shift)
Why is that work hard to automate?

Much of it comes down to where and how the work happens. In-person, hands-on and high-stakes work is where AI and robots have made the least headway so far. In the official O*NET survey of people in this job:

  • 73% talk face to face with others every day
What are companies actually doing?

We track 1 sourced company move that affects this job. Most recent:

  • Jun 2, 2025: FDA launches agencywide generative AI tool Elsa for reviewers (Rolling out)
How much time does AI save on these tasks?

For the 2 tasks in this job where AI shows up and timing data exists, a typical request takes about 7h 48m for a person alone and about 40m with AI. These are Claude's own estimates from real conversations in April and May 2026 (Anthropic Economic Index). They describe single requests, not whole workdays, and time saved on a task doesn't mean jobs are cut. The biggest gaps:

  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards (about 8h 8m alone, 37m with AI)
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products (about 7h 28m alone, 43m with AI)
Are employers still hiring regulatory affairs managers?

On Indeed, job postings in the Management sector are at 104% of their February 2020 level (all U.S. postings: 104%), up 8.3% from a year earlier, as of Oct 9, 2026. BLS separately expects about 101,000 openings a year in this job through 2035. Across all U.S. postings, 7.3% now mention AI skills. Sector postings cover more than this one job and move for many reasons besides AI.

How much do regulatory affairs managers make?

The median pay is about $141,900 a year ($68.22 an hour), 178% above the median for all U.S. jobs ($50,980). Most people in this job earn between $74,300 and $238,270 a year; that range covers the middle 80%. Pay figures are from BLS, May 2025, and vary a lot by state and employer. Pick a state to compare:

Is this job growing or shrinking?

BLS projects growth of 4.9% from 2025 to 2035, compared with 3.5% growth for all jobs. That's about 1.4 million jobs in 2035. It expects about 101,000 openings a year, mostly from people retiring or changing careers. These projections don't single out AI as a cause.

How many regulatory affairs managers are there in the U.S.?

About 622,000 people in the U.S., roughly 0.40% of all workers (BLS, May 2025). That makes it the 67th largest of the 796 jobs on this site. BLS expects about 1.4 million in 2035.

What training do regulatory affairs managers need?

The most common requirement is a bachelor's degree: about 74% of people in the job said so in the official O*NET survey. O*NET rates the job at level 4 of 5 for preparation, which usually means: bachelor's degree. Requirements vary by state and employer, especially for licensed work.

What should I learn to stay ahead of AI?

These come from the job's official skill ratings and from the tasks that AI and robots touch least today. Building them keeps you strong in the parts of the work that still need a person:

  • Skills that matter more here than in most jobs: Systems Evaluation, Systems Analysis, Writing, Time Management
  • Get strong at the parts of the job that stay with people (listed above), which take 5h 55m of a typical shift
  • Tools employers list: Microsoft PowerPoint, Microsoft Outlook, Microsoft Office software, Microsoft Excel, Adobe Acrobat
  • Learn to use AI well on the tasks where it already shows up in this job (listed above)
What other jobs could regulatory affairs managers move into?

These use similar skills, with less of a typical shift touched by AI or robots. Matches come from 109 official ratings of skills, knowledge and work activities, and each needs the same or less preparation unless the official list relates the jobs directly:

  • Regulatory Affairs Specialists (44m touched, $81k median pay)
  • Compliance Managers (54m touched, $142k median pay)
How solid are these numbers?

Each task carries its own evidence label. For this job: 4 observed in real AI use, 23 with no AI or robot evidence found. The minutes per task are estimates, not measured hours, and "no evidence" doesn't prove a task is safe.

Tools in demand

  • Adobe Acrobat
  • Microsoft Access
  • Microsoft Project
  • Microsoft SharePoint

Plus everyday office tools: Microsoft PowerPoint, Microsoft Outlook, Microsoft Office software, Microsoft Excel.

Also called

CMC Director (Chemistry, Manufacturing, and Controls Director), CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager), Compliance Director, Global RA Director (Global Regulatory Affairs Director), Global RA Manager (Global Regulatory Affairs Manager), RA Director (Regulatory Affairs Director), RA Manager (Regulatory Affairs Manager), RA QA Director (Regulatory Affairs Quality Assurance Director), RA VP (Regulatory Affairs Vice President), RA and Compliance Director (Regulatory Affairs and Compliance Director), Regulatory Affairs Executive, Regulatory Director, Regulatory Manager, Regulatory Oversight Manager