Career profile · 11-9199
Regulatory Affairs Managers
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
What the work can involve
- 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.
Selected core tasks from O*NET 31.0. Responsibilities vary by employer, specialization and experience.
Preparation and entry routes
This O*NET group commonly calls for substantial preparation, often including a bachelor’s degree or considerable relevant experience. An introductory vocational course alone may not provide an entry route.
Check the route for the specific occupation where you plan to work. Education, employer experience requirements, occupational licensing and industry certification can be separate steps.
Understand the different credentials →Skills used in this occupation
- Writing
- Reading Comprehension
- Active Listening
- Speaking
- Critical Thinking
Selected from the highest importance ratings available in O*NET 31.0. These describe the occupation, not a particular school's curriculum.
Knowledge to build
- English Language
- Law and Government
- Administration and Management
- Biology
- Education and Training
Selected from the highest importance ratings available in O*NET 31.0. These describe the occupation, not a particular school's curriculum.
Common work activities
- Evaluating Information to Determine Compliance with Standards
- Communicating with People Outside the Organization
- Communicating with Supervisors, Peers, or Subordinates
- Interpreting the Meaning of Information for Others
- Getting Information
Selected from the highest importance ratings available in O*NET 31.0. These describe the occupation, not a particular school's curriculum.
Training subjects to investigate
The federal education-to-occupation crosswalk connects this role to the subjects below. These links do not endorse a school or guarantee that any particular award qualifies a graduate for the job.
Working conditions to consider
These are the most common published responses to selected O*NET work-setting questions. They describe occupation-level survey findings, not every employer or a particular job.
| Work-setting question | Most common response | Share giving that response |
|---|---|---|
| Contact With Others | Contact with others most of the time | 43.5%08/2024 · sample 23 |
| Exposed to Contaminants | Never | 68.2%08/2024 · sample 22 |
| Exposed to Disease or Infections | Never | 82.6%08/2024 · sample 23 |
| Exposed to Hazardous Conditions | Never | 78.3%08/2024 · sample 23 |
| Spend Time Sitting | Continually or almost continually | 77.3%08/2024 · sample 22 |
| Spend Time Standing | Never | 47.8%08/2024 · sample 23 |
| Spend Time Using Your Hands to Handle, Control, or Feel Objects, Tools, or Controls | Never | 81.8%08/2024 · sample 22 |
| Time Pressure | Once a month or more but not every week | 52.2%08/2024 · sample 23 |
| Wear Common Protective or Safety Equipment such as Safety Shoes, Glasses, Gloves, Hearing Protection, Hard Hats, or Life Jackets | Never | 56.5%08/2024 · sample 23 |
| Work Schedules | Regular (established routine, set schedule) | 91.3%08/2024 · sample 23 |
O*NET 31.0 Work Context, selected topics. Only unsuppressed source responses with sample size at least 10 are shown. A most-common response need not be a majority. Sampling uncertainty applies; source dates vary. Ask employers about actual schedules, accessibility, protective equipment and working conditions.
Software used in the workplace
Use these O*NET examples to ask how a course builds practical digital skills. They are workplace examples, not a required shopping list or confirmation of a school’s curriculum.
- Analytical or scientific software: Analyse-it, Statistical analysis software
- Business intelligence and data analysis software: Tableau
- Compliance software: Aris Global Register, MediRegs E-dition Compliance Monitor, MediRegs Pharmaceutical Regulation Suite, MediRegs Regulation and Reimbursement Suite
- Data base user interface and query software: Database software, Microsoft Access, Structured query language SQL
- Desktop publishing software: Document publishing software
- Development environment software: Integrated development environment IDE software, Software development tools
- Document management software: Adlib Express, Adobe Acrobat, Axway eSubmissions, Datafarm S-Cubed
- Electronic mail software: IBM Notes, Microsoft Outlook
- Enterprise application integration software: XML authoring software
- Enterprise resource planning ERP software: SAP software
- Information retrieval or search software: Dialog DialogLink
- Internet browser software: Web browser software
Selected categories and examples from O*NET 31.0 Software Skills. Products and employer requirements change. These examples are not endorsements; check the complete official occupation profile.
Physical demands and schedule evidence
BLS surveyed jobs in the broader occupation Managers, all other (SOC 11-9199). These preliminary 2025 estimates describe work requirements across surveyed employers. Individual workplaces, adjustments and duties differ.
Explore 55 occupational requirement estimates
| Requirement | Share of workers | Standard error |
|---|---|---|
| Workers that had work schedule variability required | 41.1% | 13.1 percentage points |
| Workers that had the ability to pause work Estimate is greater than 95 percent. This estimate is the mode for the category group. | >95% | Not published The standard error is not available for this estimate. |
| Workers that had the ability to telework | 34.8% | 9.4 percentage points |
| Workers that required on-the-job training This estimate is the mode for the category group. | 67.0% | 9.0 percentage points |
| Workers that required prior work experience Estimate is greater than 99.5 percent. This estimate is the mode for the category group. | >99.5% | Not published The standard error is not available for this estimate. |
| Workers that were not exposed to extreme cold Estimate is greater than 99.5 percent. This estimate is the mode for the category group. | >99.5% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to extreme cold, seldom Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to extreme cold, occasionally Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to extreme cold, frequently Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to extreme cold, constantly Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to extreme cold Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that were not exposed to extreme heat Estimate is greater than 80 percent. This estimate is the mode for the category group. | >80% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to extreme heat, seldom Estimate is less than 20 percent. | <20% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to extreme heat, occasionally Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to extreme heat, frequently Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to extreme heat, constantly Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to extreme heat Estimate is less than 20 percent. | <20% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to quiet noise | 21.6% | 8.3 percentage points |
| Workers that were exposed to moderate noise This estimate is the mode for the category group. | 68.2% | 10.7 percentage points |
| Workers that were exposed to very loud noise Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that used personal protective equipment to mitigate exposure to noise Estimate is less than 40 percent. | <40% | Not published The standard error is not available for this estimate. |
| Workers that were not exposed to outdoors This estimate is the mode for the category group. | 78.0% | 8.3 percentage points |
| Workers that were exposed to outdoors, seldom | 4.5% | 1.9 percentage points |
| Workers that were exposed to outdoors, occasionally | 17.3% | 7.8 percentage points |
| Workers that were exposed to outdoors, frequently Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to outdoors, constantly Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that were exposed to outdoors | 22.0% | 8.3 percentage points |
| Workers that were allowed the choice of sitting or standing This estimate is the mode for the category group. | 71.1% | 10.4 percentage points |
| Workers that were not allowed the choice of sitting or standing | 28.9% | 10.4 percentage points |
| Workers that required climbing ladders, ropes, or scaffolds, seldom Estimate is less than 40 percent. | <40% | Not published The standard error is not available for this estimate. |
| Workers that required climbing ladders, ropes, or scaffolds, occasionally Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that required climbing ladders, ropes, or scaffolds, frequently Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that required climbing ladders, ropes, or scaffolds, constantly Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that required climbing ladders, ropes, or scaffolds Estimate is less than 40 percent. | <40% | Not published The standard error is not available for this estimate. |
| Workers that required driving This estimate is the mode for the category group. | 64.6% | 9.7 percentage points |
| Workers that required low postures, seldom | 19.1% | 7.6 percentage points |
| Workers that required low postures, occasionally | 24.6% | 14.2 percentage points |
| Workers that required low postures, frequently Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that required low postures, constantly Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that required work in low postures | 43.7% | 12.0 percentage points |
| Workers that could choose to crawl when in low postures Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that could choose to stoop when in low postures | 26.4% | 10.4 percentage points |
| Workers that could choose to kneel when in low postures Estimate is less than 45 percent. | <45% | Not published The standard error is not available for this estimate. |
| Workers that required reaching overhead, seldom | 32.6% | 12.0 percentage points |
| Workers that required reaching overhead, occasionally Estimate is less than 30 percent. | <30% | Not published The standard error is not available for this estimate. |
| Workers that required reaching overhead, frequently Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that required reaching overhead, constantly Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that required reaching overhead with one hand | 11.8% | 5.9 percentage points |
| Workers that required reaching overhead with both hands This estimate is the mode for the category group. | 32.4% | 13.4 percentage points |
| Workers that required reaching overhead | 44.2% | 11.8 percentage points |
| Workers that required a sedentary strength level This estimate is the mode for the category group. | 51.1% | 11.4 percentage points |
| Workers that required a light strength level | 23.5% | 10.0 percentage points |
| Workers that required a medium strength level | 23.4% | 13.4 percentage points |
| Workers that required a heavy strength level Estimate is less than 0.5 percent. | <0.5% | Not published The standard error is not available for this estimate. |
| Workers that required a very heavy strength level Estimate is less than 5 percent. | <5% | Not published The standard error is not available for this estimate. |
Use this evidence to ask about the actual work environment and available accommodations. It is not a medical assessment or a reason to rule yourself out of an occupation.
BLS Occupational Requirements Survey, preliminary 2025, released January 16, 2026; samples collected August 2023–July 2025. Source bounds such as “less than” are preserved. Categories are not necessarily additive. Understanding standard errors.
Pay & employment outlook
Salary estimates for regulatory affairs managers
This O*NET specialty shares the BLS 11-9199 occupation series. Pay is measured for Managers, All Other, not separately for this specialty.
The median divides workers into two equally sized groups by pay. It is not a starting salary, a school’s graduate outcome or a promise of employment. Lower percentiles are not automatically new graduates.
National outlook: 2025–2035
- Typical education for entry
- Bachelor's degree
- Related work experience
- Less than 5 years
- Typical on-the-job training
- None
BLS national employment projections, 2025–2035. Openings include people leaving occupations or the labor force; these are not advertised vacancies. Education categories describe typical entry, not legal eligibility or a guarantee that any specific program is sufficient.
Compare wages across 51 state/DC estimates
| State | Annual median | Hourly median | Employment |
|---|---|---|---|
| Alabama | $135,890 | $65.33 | 1,970 |
| Alaska | $127,950 | $61.51 | 1,740 |
| Arizona | $129,870 | $62.44 | 8,540 |
| Arkansas | $87,520 | $42.08 | 5,690 |
| California | $174,560 | $83.92 | 99,580 |
| Colorado | $171,140 | $82.28 | 14,060 |
| Connecticut | $162,690 | $78.22 | 7,330 |
| Delaware | $168,060 | $80.80 | 1,280 |
| District of Columbia | $175,720 | $84.48 | 18,570 |
| Florida | $108,890 | $52.35 | 37,820 |
| Georgia | $125,000 | $60.10 | 34,680 |
| Hawaii | $130,000 | $62.50 | Not published |
| Idaho | $131,550 | $63.24 | 1,230 |
| Illinois | $140,240 | $67.42 | 31,680 |
| Indiana | $79,900 | $38.42 | 6,990 |
| Iowa | $128,080 | $61.58 | 3,600 |
| Kansas | $131,710 | $63.32 | 2,690 |
| Kentucky | $122,930 | $59.10 | 2,390 |
| Louisiana | $103,140 | $49.59 | 13,220 |
| Maine | $115,920 | $55.73 | 1,860 |
| Maryland | $159,040 | $76.46 | 17,530 |
| Massachusetts | $182,950 | $87.96 | 10,630 |
| Michigan | $134,260 | $64.55 | 9,380 |
| Minnesota | $152,600 | $73.37 | 4,160 |
| Mississippi | $101,570 | $48.83 | 960 |
| Missouri | $125,760 | $60.46 | 11,420 |
| Montana | $110,470 | $53.11 | 1,600 |
| Nebraska | $116,430 | $55.98 | 2,640 |
| Nevada | $112,040 | $53.87 | 9,110 |
| New Hampshire | $145,630 | $70.02 | 1,330 |
| New Jersey | $161,510 | $77.65 | 30,270 |
| New Mexico | $123,550 | $59.40 | 3,770 |
| New York | $167,200 | $80.39 | 18,470 |
| North Carolina | $141,160 | $67.87 | 21,830 |
| North Dakota | $126,440 | $60.79 | 2,040 |
| Ohio | $129,940 | $62.47 | 7,360 |
| Oklahoma | $131,870 | $63.40 | 1,340 |
| Oregon | $125,580 | $60.38 | 7,680 |
| Pennsylvania | $131,600 | $63.27 | 20,170 |
| Rhode Island | $165,900 | $79.76 | 790 |
| South Carolina | $129,960 | $62.48 | 2,210 |
| South Dakota | $119,470 | $57.44 | 570 |
| Tennessee | $99,430 | $47.80 | 17,510 |
| Texas | $134,390 | $64.61 | 61,410 |
| Utah | $134,890 | $64.85 | 9,190 |
| Vermont | $125,440 | $60.31 | 1,060 |
| Virginia | $166,230 | $79.92 | 21,560 |
| Washington | $164,160 | $78.92 | 10,490 |
| West Virginia | $124,940 | $60.07 | 3,640 |
| Wisconsin | $107,050 | $51.46 | 14,240 |
| Wyoming | $113,420 | $54.53 | 850 |
Metropolitan and nonmetropolitan wages
Search the 516 published local-area estimates for this occupation. Metropolitan areas can cross state lines; a city’s postal name is not necessarily the statistical area’s name.
Sources: BLS May 2025 OEWS public downloads and 2025–2035 employment projections, retrieved September 9, 2026. Unpublished estimates stay unavailable. “+” means BLS’s upper reporting threshold ($239,200 annually or $115 hourly). Wages exclude self-employment and nonwage benefits. How to interpret these figures.
Compare the route and prepare for work
Questions to test the fit
- What does an entry-level working day look like, and how does it differ from the experienced role described here?
- Which tasks, work environments and schedules would I enjoy or find difficult?
- What education, supervised practice and credentials do local employers actually request?
- Can I speak with someone in the occupation or arrange a suitable workplace visit?
- How does the complete training cost compare with my realistic budget and available routes?
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Related through shared training-subject mappings. Entry requirements can differ substantially.
Sources and attribution
This page includes information from the O*NET 31.0 Database by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under CC BY 4.0. Trade School Guides selects and organizes the material and adds explanatory guidance. USDOL/ETA has not approved, endorsed or tested these modifications. Occupation code: 11-9199.01.
Training connections: CIP 2020–SOC 2018 crosswalk. Snapshot: September 8, 2026. See the methodology.