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 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.
- 1846 EloClaude Opus 5.5 (Adaptive Reasoning, Max Effort, Default Fallback) · 23 Sep 2026Unrated
- 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