Regulatory Affairs Specialists: Career Profile
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.
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The Daily Work of Regulatory Affairs Specialists Take On?
The core tasks performed by regulatory affairs specialists include:
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Coordinate recall or market withdrawal activities as necessary.
What Regulatory Affairs Specialists Need to Know
Successful regulatory affairs specialists draw on a mix of skills and domain knowledge.
Top Skills
The competencies that matter most in this role, rated on an importance scale of 0 to 5:
Top Knowledge Areas
Related Job Titles
Common job titles for this role include:
- Anti Money Laundering Compliance Analyst (AML Compliance Analyst)
- CMC Regulatory Affairs Manager (Chemistry, Manufacturing, and Controls Regulatory Affairs Manager)
- Clinical Quality Assurance Associate
- Clinical Quality Assurance Specialist
- Drug Regulatory Affairs Specialist
- Product Safety Specialist
- Product Stewardship Specialist
- Quality Assurance Documentation Coordinator
Employment and Demand
There are roughly 326,183 regulatory affairs specialists working in the United States today. This occupation is expected to grow by +14.4% over the projection horizon.
How Much Do Regulatory Affairs Specialists Make?
| Statistic | Value |
|---|---|
| Annual median | $85,399 |
| Hourly median | $41.06 |
| 10th percentile | $53,889 |
| 25th percentile | $69,644 |
| 75th percentile | $101,153 |
| 90th percentile | $116,908 |
Pay can vary substantially based on experience, location, and industry.
Regulatory Affairs Specialists Salary by State
| State | Annual median salary |
|---|---|
| District of Columbia | $103,010 |
| New Jersey | $93,520 |
| Massachusetts | $92,890 |
| California | $92,350 |
| Alaska | $88,730 |
| Vermont | $88,550 |
| Delaware | $88,450 |
| Maryland | $87,580 |
| Connecticut | $87,210 |
| Maine | $86,940 |
| New York | $86,880 |
| Washington | $86,200 |
| Minnesota | $85,220 |
| Oregon | $84,210 |
| Rhode Island | $83,200 |
| New Hampshire | $82,530 |
| Virginia | $80,990 |
| Hawaii | $80,930 |
| Colorado | $80,590 |
| Wyoming | $80,150 |
| Illinois | $79,350 |
| Nevada | $78,940 |
| North Dakota | $78,450 |
| South Carolina | $76,200 |
| Wisconsin | $75,780 |
| Michigan | $75,300 |
| Ohio | $75,030 |
| North Carolina | $74,810 |
| Pennsylvania | $73,840 |
| Iowa | $73,530 |
| Arizona | $73,070 |
| Texas | $72,050 |
| Indiana | $71,980 |
| South Dakota | $71,700 |
| Florida | $70,460 |
| Alabama | $70,190 |
| New Mexico | $67,640 |
| Kentucky | $67,490 |
| Kansas | $66,980 |
| Nebraska | $65,960 |
| Idaho | $65,350 |
| Virgin Islands | $65,210 |
| Mississippi | $65,150 |
| Missouri | $64,960 |
| Utah | $64,730 |
| West Virginia | $64,040 |
| Georgia | $63,990 |
| Tennessee | $63,760 |
| Louisiana | $63,730 |
| Arkansas | $63,560 |
| Montana | $63,330 |
| Oklahoma | $61,730 |
| Puerto Rico | $46,570 |
Where Regulatory Affairs Specialists Earn the Most
Pay for regulatory affairs specialists vary by region. The following regions pay the most:
| Region | Median annual wage | Share of U.S. jobs | Location quotient |
|---|---|---|---|
| Far Western US | $89,808 | 17.1% | 1.04 |
| New England | $89,791 | 5.3% | 1.22 |
| Middle Atlantic | $86,241 | 16.5% | 1.15 |
| Great Lakes | $75,873 | 10.3% | 0.74 |
| Rocky Mountains | $73,182 | 3.7% | 0.94 |
| Plains States | $72,241 | 6.5% | 0.97 |
| Southwest | $71,347 | 14.4% | 1.17 |
| Southeast | $70,480 | 24.9% | 1.08 |
Top Metro Areas
| Metro area | State | Median annual wage | Employment |
|---|---|---|---|
| San Jose-Sunnyvale-Santa Clara, CA | CA | $118,490 | 2,690 |
| Lexington Park, MD | MD | $105,610 | 150 |
| Brunswick-St. Simons, GA | GA | $104,330 | 640 |
| San Francisco-Oakland-Fremont, CA | CA | $104,000 | 7,350 |
| Washington-Arlington-Alexandria, DC-VA-MD-WV | DC | $102,500 | 14,110 |
| Bellingham, WA | WA | $101,870 | 650 |
| El Centro, CA | CA | $101,110 | 850 |
| San Diego-Chula Vista-Carlsbad, CA | CA | $98,190 | 6,000 |
Top Industries Employing Regulatory Affairs Specialists
Most regulatory affairs specialists work in these industries:
| Industry | Employment | Median annual wage |
|---|---|---|
| Finance and Insurance | 46,410 | $79,920 |
| Professional, Scientific, and Technical Services | 38,020 | $90,990 |
| Health Care and Social Assistance | 32,070 | $68,590 |
| Management of Companies and Enterprises | 22,870 | $89,740 |
| Administrative and Support and Waste Management and Remediation Services | 18,660 | $60,800 |
| Manufacturing | 18,630 | $85,040 |
| Educational Services | 15,080 | $74,650 |
| Transportation and Warehousing | 14,480 | $63,430 |
The table below shows some of the most common industries where those employed in this career field work.
Software Regulatory Affairs Specialists Use
- Document management software: Adobe Acrobat (hot technology)
- Data base user interface and query software: Microsoft Access (hot technology)
- Spreadsheet software: Microsoft Excel (hot technology)
- Office suite software: Microsoft Office software (hot technology)
- Electronic mail software: Microsoft Outlook (hot technology)
- Presentation software: Microsoft PowerPoint (hot technology)
- Project management software: Microsoft Project (hot technology)
- Document management software: Microsoft SharePoint (hot technology)
- Data base user interface and query software: Microsoft SQL Server (hot technology)
- Process mapping and design software: Microsoft Visio (hot technology)
- Development environment software: Microsoft Visual Basic (hot technology)
- Word processing software: Microsoft Word (hot technology)
What the Workplace Is Like
The work environment for regulatory affairs specialists is shaped by the following characteristics:
- Spend Time Sitting
- Indoors, Environmentally Controlled
- Work With or Contribute to a Work Group or Team
- Telephone Conversations
Education and Training
Entry-level regulatory affairs specialists positions require a bachelor’s degree as the typical entry-level education. The role falls in Considerable Preparation Needed (Job Zone 4), reflecting the level of preparation typically expected.
Related Careers
Similar Occupations
- Quality Control Systems Managers (Primary-Long)
- Clinical Research Coordinators (Supplemental)
- Regulatory Affairs Managers (Primary-Short)
- Compliance Managers (Primary-Short)
- Compliance Officers (Primary-Short)
- Environmental Compliance Inspectors (Primary-Short)
- Equal Opportunity Representatives and Officers (Primary-Long)
- Government Property Inspectors and Investigators (Primary-Short)
Degree Programs
Students preparing for regulatory affairs specialists often complete programs in:
Natural Resources and Conservation
4 programs across 2 majors
Business, Management, Marketing, and Related Support Services
2 programs across 1 majors
Multi/Interdisciplinary Studies
1 programs across 1 majors
Sources
This profile draws on the following authoritative sources:
- U.S. Bureau of Labor Statistics — Occupational Employment and Wage Statistics (OEWS) for employment and wage data by state and industry.
- BLS Employment Projections for total employment and growth forecasts.
- O*NET (Occupational Information Network) for skills, knowledge, tasks, work activities, work context, technology, and education-zone data.
SOC code: 13-1041.07 (Compliance Officers).
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