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US job code 13-1041.07Very high change by 2035

Regulatory Affairs Specialists

Machines can already do 47% of this job's tasks. By 2035 that rises to 76%. The job changes before it disappears.

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Share of the work machines can do

Worldwide baseline, 2026 to 2050

100%75%50%25%20262035205047%Half: 2028

Regulatory Affairs Specialists in 2026: the short answer

  • Today: machines can do 47% of this job's tasks, and AI use is already seen in 12% of them.
  • Forecast: machines can do half of its tasks by 2028, and 76% by 2035, according to the 311 Strategic Intelligence Unit.
  • Size: 417,070 people do this job in the United States, on a median pay of $80,730 a year.
  • Contact with people: it scores 62% for contact with people.
  • Also called: Drug Regulatory Affairs Specialist, QA Specialist (Quality Assurance Specialist), RA Analyst (Regulatory Affairs Analyst), RA Associate (Regulatory Affairs Associate).

Updated by the 311 Strategic Intelligence Unit. These are worldwide baseline figures; the Workforce Starburst shows them for your country. Go deeper: How ready am I? or an executive briefing.

Machines can do today
47%of the tasks, 2026
By 2035
76%half the tasks by 2028
US median pay
$80,730a year, May 2025
US jobs
417k417,070 people
Contact with people
62%how people-facing
Step 1AnticipateWhat is changing? Free to everyone

How the work changes, task by task

The tasks that take up most of the day, with the share of each that machines can do in 2026 (dark) and 2035 (pink). Worldwide baseline.

TaskShare of the dayMachines can do2026 to 2035
Coordinate efforts associated with the preparation of regulatory documents or submissions12%
25% to 55%
Coordinate, prepare, or review regulatory submissions for domestic or international projects10%
48% to 75%
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies6%
50% to 85%
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review5%
55% to 85%
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies5%
25% to 55%
Prepare or maintain technical files as necessary to obtain and sustain product approval5%
70% to 95%
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues5%
35% to 65%
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation5%
25% to 55%
Step 2AssessWhy should I care? Free to everyone

The skills this job runs on

The skills regulatory affairs specialists use most, most used first.

Professionalism and work ethicMoral intelligence and integrityCommunicationLearning aptitude and mindsetCritical thinking and problem solvingAnalysis and dataManagementLegal knowledgeCollaborationInterpersonal skillsAdaptability and resilienceEntrepreneurial mindsetLeadershipSelf-management

Safer jobs nearby

Jobs with a similar skill shape where machines can do less of the work by 2035.

Step 3ActWhat do I do about it? Free plan and up
What do I do about it

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Questions

When will machines do half of the tasks of Regulatory Affairs Specialists?

Machines can do half of its tasks by 2028. That is the worldwide baseline from the 311 Workforce Starburst, before adjusting for country.

Will AI take the job of regulatory affairs specialists?

Machines can do 47% of the tasks of regulatory affairs specialists today and 76% by 2035. Most of the routine work moves to machines, and the people in the job move to oversight, judgement and client work.

Sources and citing

Tasks and their share of the day: O*NET 31.0, occupation 13-1041.07 (US Department of Labor, CC BY 4.0). Pay and jobs: US Bureau of Labor Statistics, Occupational Employment and Wage Statistics, May 2025. AI use today: Anthropic Economic Index (CC BY). Scoring and forecast: the 311 Strategic Intelligence Unit; after 2035 the figures extend each trend, with lower confidence. Foresight, not advice.

Cite as: 311 Institute (2026). Regulatory Affairs Specialists: the outlook to 2050. 311 Workforce Starburst. https://www.311institute.com/jobs/regulatory-affairs-specialists/