Regulatory Affairs Specialists Career, Salary and Skills
Regulatory Affairs Specialists have a BLS-reported national median annual wage of $80,730 based on the 2025 OEWS dataset, with reported national employment of 417,070. Wage data is published for 445 locations.
Occupation description
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.
O*NET code
13-1041.07
Job zone
4
Typical education
Bachelor's Degree
Experience
Over 2 years, up to and including 4 years
National salary and employment
Median annual
$80,730
Hourly median
$38.81
Employment
417,070
Data year
2025
National salary distribution
Top skills
| Skill | Importance | Level |
|---|---|---|
| Reading Comprehension | 4.00 | 4.88 |
| Speaking | 4.00 | 4.50 |
| Active Listening | 4.00 | 4.25 |
| Judgment and Decision Making | 4.00 | 4.25 |
| Writing | 4.00 | 4.50 |
| Critical Thinking | 4.00 | 4.62 |
| Complex Problem Solving | 3.88 | 4.00 |
| Systems Analysis | 3.88 | 4.12 |
| Active Learning | 3.75 | 4.12 |
| Systems Evaluation | 3.75 | 4.00 |
Typical tasks
- 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, prepare, or review regulatory submissions for domestic or international projects.
Technology
- Adobe Acrobat
- Analyse-it
- Atrion Intelligent Authoring
- DataVision
- FileMaker Pro
- Fund accounting software
- Healthcare common procedure coding system HCPCS
- Human resource management software HRMS
- Integrated development environment IDE software
- LexisNexis
- McAfee
- Medical procedure coding software
- Microsoft Access
- Microsoft Dynamics
Regulatory Affairs Specialists salary by location
Areas with the highest reported employment for this occupation.
- Regulatory Affairs Specialists Salary in CAMedian $96,980 · Employment 49,880
- Regulatory Affairs Specialists Salary in TXMedian $75,370 · Employment 42,900
- Regulatory Affairs Specialists Salary in FLMedian $74,920 · Employment 29,680
- Regulatory Affairs Specialists Salary in NYMedian $90,080 · Employment 23,500
- Regulatory Affairs Specialists Salary in New York, NYMedian $101,050 · Employment 23,380
- Regulatory Affairs Specialists Salary in PAMedian $85,580 · Employment 19,810
- Regulatory Affairs Specialists Salary in Los Angeles, CAMedian $94,810 · Employment 17,700
- Regulatory Affairs Specialists Salary in VAMedian $80,380 · Employment 15,190
- Regulatory Affairs Specialists Salary in GAMedian $70,200 · Employment 14,390
- Regulatory Affairs Specialists Salary in Washington, DCMedian $100,200 · Employment 13,820
- Regulatory Affairs Specialists Salary in NJMedian $100,000 · Employment 13,310
- Regulatory Affairs Specialists Salary in MAMedian $102,060 · Employment 13,190
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Career and skills data: O*NET 31.0 (onetcenter.org). Salary and employment data: U.S. Bureau of Labor Statistics OEWS, 2025 (bls.gov/oes). Figures are published survey estimates, not real-time market data.