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.

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