Jobs / Management and business operations / 13-1041.07
Regulatory Affairs Specialists
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.
- US jobs
- 417,070 (SOC 13-1041 group, "Compliance Officers")
- Median wage
- $80,730 a year
- Job family
- Management and business operations
Can agents do the work of regulatory affairs specialists?
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.
14% of this occupation's work, by O*NET work activities, is measured by a direct benchmark (figures for the SOC 13-1041 group).
- 7%Investigate criminal or legal mattersNot measured
- 7%Examine materials or documentation for accuracy or complianceMeasured
- 7%Provide information to guests, clients, or customersNot measured
- 6%Prepare legal or regulatory documentsNot measured
- 5%Monitor operations to ensure compliance with regulations or standardsMeasured
- 4%Direct organizational operations, activities, or proceduresNot measured
- 4%Advise others on legal or regulatory mattersNot measured
- 4%Inspect facilities or equipmentNot measured
Benchmarks for this occupation
These benchmarks name this occupation in their job mapping.
Direct evidence
Work benchmarks mapped primary to this family. They set the step when they report how many tasks agents complete.
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.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Coordinate recall or market withdrawal activities as necessary.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Develop regulatory strategies for products.
- Identify relevant guidance documents, international standards, or consensus standards.
Other job titles for this occupation (24)
Drug Regulatory Affairs Specialist · QA Specialist (Quality Assurance Specialist) · RA Analyst (Regulatory Affairs Analyst) · RA Associate (Regulatory Affairs Associate) · RA Consultant (Regulatory Affairs Consultant) · RA Strategist (Regulatory Affairs Strategist) · Regulatory Consultant · Regulatory Services Consultant · Regulatory Specialist · Regulatory Submissions Associate · QA Documentation Coordinator (Quality Assurance Documentation Coordinator) · QA Documentation Specialist (Quality Assurance Documentation Specialist) · RA Coordinator (Regulatory Affairs Coordinator) · Regulatory Affairs Scientist (RA Scientist) · Regulatory Analyst · Regulatory Compliance Associate · Regulatory Compliance Specialist · Regulatory Coordinator · Regulatory Reporting Analyst · Regulatory Scientist · Research Compliance Specialist · Research QA Analyst (Research Quality Assurance Analyst) · Research QA Specialist (Research Quality Assurance Specialist) · Risk and Compliance Analyst