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Regulatory Affairs Specialist

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What Does it Take to Be a Regulatory Affairs Specialist?

Occupation 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: What Do They Do?

  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Monitor national or international legislation on ozone-depleting substances or global warming.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.

What Skills Do You Need to Work as a Regulatory Affairs Specialist?

When polled, Regulatory Affairs Specialists say the following skills are most frequently used in their jobs:

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.

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

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

Types of Regulatory Affairs Specialist Jobs

  • Regulatory Affairs Associate
  • Regulatory Affairs Analyst
  • Regulatory Services Consultant
  • Compliance Specialist
  • Quality Assurance Documentation Coordinator

Job Outlook for Regulatory Affairs Specialists

In 2016, there was an estimated number of 288,300 jobs in the United States for Regulatory Affairs Specialist. 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. Due to new job openings and attrition, there will be an average of 25,900 job openings in this field each year.

Forecasted Number of Jobs for Regulatory Affairs Specialists in U.S.

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.

Salary for a Regulatory Affairs Specialist

The average yearly salary of a Regulatory Affairs Specialist ranges between $38,320 and $109,650.

Salary Ranges for Regulatory Affairs Specialists

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

How much do Regulatory Affairs Specialists make in each U.S. state?

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 Visio
  • Microsoft SharePoint
  • Structured query language SQL
  • Microsoft Dynamics
  • FileMaker Pro
  • Microsoft SQL Server
  • LexisNexis
  • Medical procedure coding software
  • MicroStrategy
  • Qlik Tech QlikView

How do I Become a Regulatory Affairs Specialist?

Education needed to be a Regulatory Affairs Specialist:

Regulatory Affairs Specialist Degree Level

What work experience do I need to become a Regulatory Affairs Specialist?

Regulatory Affairs Specialist Work Experience

Regulatory Affairs Specialists Sector

Regulatory Affairs Specialist Sectors

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

Regulatory Affairs Specialist Industries

References:

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More about our data sources and methodologies.

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