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Regulatory Affairs Specialist

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All About Regulatory Affairs Specialists

Position 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.

Life As a Regulatory Affairs Specialist

  • Write or update standard operating procedures, work instructions, or policies.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Participate in internal or external audits.
  • Coordinate recall or market withdrawal activities as necessary.

What a Regulatory Affairs Specialist Should Know

These are the skills Regulatory Affairs Specialists say are the most useful in their careers:

Active Listening: Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.

Writing: Communicating effectively in writing as appropriate for the needs of the audience.

Speaking: Talking to others to convey information effectively.

Reading Comprehension: Understanding written sentences and paragraphs in work related documents.

Critical Thinking: Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

Judgment and Decision Making: Considering the relative costs and benefits of potential actions to choose the most appropriate one.

Other Regulatory Affairs Specialist Job Titles

  • Research Compliance Specialist
  • Regulatory Affairs Consultant (RA Consultant)
  • Quality Assurance Documentation Specialist
  • Regulatory Compliance Specialist
  • Regulatory Services Consultant

Are There Job Opportunities for Regulatory Affairs Specialists?

In the United States, there were 288,300 jobs for Regulatory Affairs Specialist in 2016. New jobs are being produced at a rate of 8.2% which is above the national average. The Bureau of Labor Statistics predicts 23,700 new jobs for Regulatory Affairs Specialist by 2026. The BLS estimates 25,900 yearly job openings in this field.

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The states with the most job growth for Regulatory Affairs Specialist are Utah, Nevada, and Washington. Watch out if you plan on working in Alaska, Maine, or Maryland. These states have the worst job growth for this type of profession.

What is the Average Salary of a Regulatory Affairs Specialist

Regulatory Affairs Specialists make between $38,320 and $109,650 a year.

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Regulatory Affairs Specialists who work in District of Columbia, Alaska, or California, make the highest salaries.

How much do Regulatory Affairs Specialists make in different U.S. states?

State Annual Mean Salary
Alabama $67,700
Alaska $80,840
Arizona $64,340
Arkansas $56,820
California $82,380
Colorado $73,710
Connecticut $84,590
Delaware $77,670
District of Columbia $93,240
Florida $63,890
Georgia $63,030
Hawaii $69,980
Idaho $59,420
Illinois $74,180
Indiana $61,970
Iowa $63,340
Kansas $60,030
Kentucky $58,260
Louisiana $61,230
Maine $66,230
Maryland $77,250
Massachusetts $83,100
Michigan $71,470
Minnesota $76,190
Mississippi $54,700
Missouri $62,180
Montana $62,620
Nebraska $68,610
Nevada $67,540
New Hampshire $70,670
New Jersey $83,210
New Mexico $68,290
New York $76,370
North Carolina $67,100
North Dakota $70,970
Ohio $67,140
Oklahoma $59,340
Oregon $71,860
Pennsylvania $71,090
Rhode Island $76,440
South Carolina $61,390
South Dakota $57,930
Tennessee $61,780
Texas $74,690
Utah $59,470
Vermont $69,520
Virginia $75,900
Washington $84,340
West Virginia $60,740
Wisconsin $62,700
Wyoming $67,370

Tools & Technologies Used by Regulatory Affairs Specialists

Below is a list of the types of tools and technologies that Regulatory Affairs Specialists may use on a daily basis:

  • Microsoft Excel
  • Microsoft Word
  • Microsoft Office
  • Microsoft PowerPoint
  • Microsoft Outlook
  • Web browser software
  • Microsoft Access
  • SAP
  • Microsoft Project
  • Adobe Systems Adobe Acrobat
  • Microsoft SharePoint
  • Microsoft Visio
  • Structured query language SQL
  • Microsoft Dynamics
  • FileMaker Pro
  • Microsoft SQL Server
  • LexisNexis
  • Medical procedure coding software
  • Human resource management software HRMS
  • MicroStrategy

How to Become a Regulatory Affairs Specialist

Learn what Regulatory Affairs Specialist education requirements there are.

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How Long Does it Take to Become a Regulatory Affairs Specialist?

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Where Regulatory Affairs Specialists Work

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The table below shows the approximate number of Regulatory Affairs Specialists employed by various industries.

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References:

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More about our data sources and methodologies.

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