Regulatory Affairs Managers: Job Description
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
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What Tasks Do Regulatory Affairs Managers Do?
The day-to-day responsibilities of regulatory affairs managers include:
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Provide responses to regulatory agencies regarding product information or issues.
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
Key Skills and Knowledge
Successful regulatory affairs managers rely on a mix of skills and domain knowledge.
Key Skills
The competencies most central to this role, rated on an importance scale of 0 to 5:
Knowledge Areas
Other Regulatory Affairs Managers Job Titles
Common job titles for this role include:
- CMC Director (Chemistry, Manufacturing, and Controls Director)
- CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager)
- Compliance Director
- Global RA Director (Global Regulatory Affairs Director)
- Global RA Manager (Global Regulatory Affairs Manager)
- International Regulatory Affairs Specialist
- RA Director (Regulatory Affairs Director)
- RA Manager (Regulatory Affairs Manager)
Employment and Demand
There are about 187,752 regulatory affairs managers working in the United States today. This occupation is expected to grow by +9.9% over the projection horizon.
How Much Do Regulatory Affairs Managers Make?
| Statistic | Value |
|---|---|
| Annual median | $77,828 |
| Hourly median | $37.42 |
| 10th percentile | $50,724 |
| 25th percentile | $64,276 |
| 75th percentile | $91,380 |
| 90th percentile | $104,932 |
Wages vary widely based on experience, location, and industry.
Pay by State
| State | Annual median salary |
|---|---|
| Massachusetts | $172,380 |
| District of Columbia | $171,910 |
| California | $170,740 |
| Delaware | $170,310 |
| Washington | $165,080 |
| Colorado | $164,010 |
| New Jersey | $163,630 |
| Virginia | $162,610 |
| New York | $161,360 |
| Minnesota | $158,680 |
| Connecticut | $149,690 |
| Maryland | $148,680 |
| Rhode Island | $147,240 |
| New Hampshire | $142,650 |
| Illinois | $134,810 |
| Texas | $133,070 |
| Michigan | $133,040 |
| Arizona | $132,040 |
| North Carolina | $131,990 |
| Pennsylvania | $129,170 |
| Iowa | $127,680 |
| New Mexico | $127,060 |
| Ohio | $126,600 |
| West Virginia | $126,250 |
| Oklahoma | $124,800 |
| Oregon | $124,190 |
| Maine | $123,950 |
| Vermont | $123,930 |
| Alaska | $123,160 |
| Kentucky | $123,010 |
| Hawaii | $122,520 |
| Georgia | $120,810 |
| South Carolina | $120,640 |
| Kansas | $118,310 |
| North Dakota | $118,010 |
| Wyoming | $117,060 |
| Missouri | $117,050 |
| Alabama | $116,830 |
| Nebraska | $114,050 |
| South Dakota | $111,630 |
| Idaho | $107,800 |
| Montana | $105,840 |
| Wisconsin | $105,690 |
| Florida | $102,670 |
| Louisiana | $100,890 |
| Nevada | $99,590 |
| Mississippi | $97,780 |
| Guam | $97,210 |
| Virgin Islands | $92,270 |
| Tennessee | $88,110 |
| Arkansas | $84,610 |
| Indiana | $79,080 |
| Puerto Rico | $78,740 |
Pay by U.S. Region
Pay for regulatory affairs managers vary by region. These regions lead on median pay:
| Region | Median annual wage | Share of U.S. jobs | Location quotient |
|---|---|---|---|
| Far Western US | $160,982 | 22.6% | 1.34 |
| New England | $156,233 | 3.9% | 0.83 |
| Middle Atlantic | $153,807 | 17.6% | 2.07 |
| Southwest | $132,453 | 11.2% | 0.90 |
| Plains States | $126,095 | 4.1% | 0.64 |
| Southeast | $116,490 | 29.4% | 1.35 |
| Rocky Mountains | $112,945 | 3.8% | 1.01 |
| Great Lakes | $112,898 | 6.4% | 0.72 |
Highest-Paying Metro Areas for Regulatory Affairs Managers
| Metro area | State | Median annual wage | Employment |
|---|---|---|---|
| San Jose-Sunnyvale-Santa Clara, CA | CA | $215,120 | 13,530 |
| San Francisco-Oakland-Fremont, CA | CA | $203,030 | 22,980 |
| Lewiston-Auburn, ME | ME | $190,070 | 100 |
| Kennewick-Richland, WA | WA | $175,070 | 400 |
| Boston-Cambridge-Newton, MA-NH | MA | $174,840 | 9,240 |
| Boulder, CO | CO | $173,490 | 1,080 |
| Binghamton, NY | NY | $171,190 | 190 |
| Seattle-Tacoma-Bellevue, WA | WA | $168,750 | 7,580 |
Which Industries Hire Regulatory Affairs Managers
Most regulatory affairs managers are concentrated in the following sectors:
| Industry | Employment | Median annual wage |
|---|---|---|
| Professional, Scientific, and Technical Services | 94,490 | $164,060 |
| Management of Companies and Enterprises | 50,980 | $163,830 |
| Manufacturing | 46,390 | $160,640 |
| Finance and Insurance | 44,890 | $162,780 |
| Information | 38,680 | $167,740 |
| Educational Services | 32,840 | $102,450 |
| Administrative and Support and Waste Management and Remediation Services | 32,500 | $109,990 |
| Health Care and Social Assistance | 31,360 | $108,810 |
The table below shows some of the most common industries where those employed in this career field work.
Tools and Technology
- 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)
- Process mapping and design software: Microsoft Visio (hot technology)
- Operating system software: Microsoft Windows (hot technology)
- Word processing software: Microsoft Word (hot technology)
- Enterprise resource planning ERP software: SAP software (hot technology)
What the Workplace Is Like
The on-the-job environment of regulatory affairs managers reflects the following characteristics:
- Work With or Contribute to a Work Group or Team
- Spend Time Sitting
- Face-to-Face Discussions with Individuals and Within Teams
- Telephone Conversations
Education and Training
Entry-level regulatory affairs managers 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)
- Medical and Health Services Managers (Supplemental)
- Natural Sciences Managers (Supplemental)
- Compliance Managers (Primary-Short)
- Compliance Officers (Primary-Long)
- Environmental Compliance Inspectors (Primary-Short)
- Government Property Inspectors and Investigators (Supplemental)
- Regulatory Affairs Specialists (Primary-Short)
Where to Study
Aspiring regulatory affairs managers commonly pursue programs in:
Social Sciences
40 programs across 14 majors
- Economics
- Political Science & Government
- Sociology
- General Social Sciences
- International Relations & Security
- Anthropology
- Criminology
- Geography & Cartography
- Other Social Sciences
- Urban Studies
- Sociology & Anthropology
- Archeology
- Demography & Population Studies
- Geography and Anthropology
Psychology
28 programs across 4 majors
Business, Management, Marketing, and Related Support Services
15 programs across 5 majors
- Business Administration & Management
- Business & Commerce
- Entrepreneurial Studies
- Hospitality Management
- Telecommunications Management
Multi/Interdisciplinary Studies
12 programs across 10 majors
- Systems Theory
- History and Language/Literature
- Philosophy, Politics, and Economics
- Digital Humanities and Textual Studies
- Economics and Computer Science
- History and Political Science
- Historic Preservation
- Geoarcheaology
- Linguistics and Anthropology
- Economics and Foreign Language/Literature
Homeland Security, Law Enforcement, Firefighting and Related Protective Services
9 programs across 4 majors
History
9 programs across 1 majors
Sources
Statistics shown above are sourced from 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: 11-9199.01 (Managers, All Other).
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