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 for the whole job family, Management and business operations: Some tasks (first measured in the last 12 months)
Agents complete 20% or more of the tasks (or projects) on a direct benchmark.
Evidence: SOP-Bench, 72.4% of tasks completed.
12% of this occupation's work, by O*NET work activities, is measured by a direct benchmark (figures for the SOC 11-9199 group).
- 6%Maintain operational recordsMeasured
- 6%Direct organizational operations, activities, or proceduresNot measured
- 5%Develop organizational policies, systems, or processesNot measured
- 4%Monitor operations to ensure compliance with regulations or standardsNot measured
- 4%Train others on operational or work proceduresNot measured
- 4%Implement procedures or processesMeasured
- 3%Develop sustainable organizational or business policies or practicesNot measured
- 3%Estimate project development or operational costsNot measured
Benchmarks for the job family
These cover work in management and business operations, not always this occupation's tasks.
Direct evidence
Work benchmarks mapped primary to this family. They set the step when they report how many tasks agents complete.
Also relevant
These benchmarks cover part of this family's work, or have no result yet. They do not set its step.
- 45.9%Claude Opus 4.6 · 16 Mar 2026Emerging
- 64.8%Claude Code + Opus 5.5 (max) · 6 Oct 2026Strong
Context only
These benchmarks span many occupations, or they test how agents behave. They give context but do not set the step.
- 42.9%TTE-MatrixAgent + DeepSeek-V3.2 · 10 Nov 2025Emerging
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