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Regulatory Affairs Managers

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Regulatory Affairs Managers: Job Description

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

The Daily Work of Regulatory Affairs Managers Take On?

The core tasks performed by regulatory affairs managers cover:

  • 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.

What Regulatory Affairs Managers Need to Know

Top regulatory affairs managers rely on a mix of skills and domain knowledge.

Most Important Skills

These are the skills most important for this role, rated on an importance scale of 0 to 5:

Writing  4.2 / 5
0
5
Reading Comprehension  4.1 / 5
0
5
Active Listening  4.0 / 5
0
5
Speaking  4.0 / 5
0
5
Critical Thinking  3.9 / 5
0
5
Systems Evaluation  3.8 / 5
0
5

Knowledge Areas

English Language  4.6 / 5
0
5
Law and Government  4.0 / 5
0
5
Administration and Management  3.7 / 5
0
5
Biology  3.4 / 5
0
5
Education and Training  3.1 / 5
0
5
Administrative  3.0 / 5
0
5

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)

Job Outlook

There are roughly 187,752 regulatory affairs managers working in the United States today. Demand is forecast to grow by +9.9% over the projection horizon.

Forecasted number of jobs for Regulatory Affairs Managers

Salary for Regulatory Affairs Managers

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

Compensation varies based on experience, location, and industry.

Salary ranges for Regulatory Affairs Managers

How Much Do Regulatory Affairs Managers Make in Different U.S. States?

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

Earnings for regulatory affairs managers shift depending on where you work. Top regions by median wage:

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

Top Metro Areas

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

Industry Breakdown

Most regulatory affairs managers are found across these industries:

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
Regulatory Affairs Managers sectors

The table below shows some of the most common industries where those employed in this career field work.

Regulatory Affairs Managers industries

Tech Stack

  • 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)

The Day-to-Day Environment

The work environment for regulatory affairs managers tends to involve the following characteristics:

  • E-Mail
  • Work With or Contribute to a Work Group or Team
  • Spend Time Sitting
  • Face-to-Face Discussions with Individuals and Within Teams
  • Telephone Conversations

Getting Started in This Career

Entry-level regulatory affairs managers positions require a bachelor’s degree as the typical entry-level education. This career aligns with Considerable Preparation Needed (Job Zone 4), signaling the level of preparation typically expected.

Similar Occupations

Similar Occupations

Where to Study

Future regulatory affairs managers often complete programs in:

Social Sciences

40 programs across 14 majors

15 programs across 5 majors

Multi/Interdisciplinary Studies

12 programs across 10 majors

1 programs across 1 majors

Natural Resources and Conservation

1 programs across 1 majors

Sources

Data on this page comes 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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