Jobs / Management and business operations / 11-9199.01

Regulatory Affairs Managers

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

US jobs
622,190 (SOC 11-9199 group, "Managers, All Other")
Median wage
$141,900 a year
Job family
Management and business operations

Can agents do the work of regulatory affairs managers?

We read the evidence at the level of the job family, Management and business operations:

  • Task levelPartialOnly adjacent evidence. On TheAgentCompany, which gives agents workplace tasks inside a simulated software company, the best agent resolves 42.9% of tasks (a November 2025 result). No task-level benchmark in our collection maps directly to management or business operations.
  • Project levelPartialMixed. OpenAI reports that GPT-5.5's GDPval deliverables won or tied against professionals' work in 84.9% of comparisons, and the best agent passes 73.5% of APEX-Agents tasks on the first try. Running a business is weaker: on Vending-Bench 2 the best model ends a simulated year with $15,515, about a quarter of Andon Labs' estimate for a good strategy.

Benchmarks for the job family

These cover work in management and business operations, not always this occupation's tasks.

Typical tasks

From O*NET 31.0. Core tasks first. Few of these tasks have a benchmark today.

  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
Other job titles for this occupation (22)

CMC Director (Chemistry, Manufacturing, and Controls Director) · 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) · Regulatory Director · Vaccine RA Director (Vaccine Regulatory Affairs Director) · CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager) · International Regulatory Affairs Specialist · RA and Compliance Director (Regulatory Affairs and Compliance Director) · Regulatory Affairs Executive · Regulatory Affairs Project Manager (Regulatory Affairs PM) · Regulatory Manager · Regulatory Operations Manager (Regulatory Ops Manager) · Regulatory Oversight Manager · Regulatory Process Manager · Regulatory Program Manager · Regulatory Reporting Manager · Regulatory Reports Manager