What You Need to Know About Regulatory Affairs Specialist
Example of Regulatory Affairs Specialist Job 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.
Regulatory Affairs Specialist Responsibilities
- Recommend changes to company procedures in response to changes in regulations or standards.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
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What Skills Do You Need to Work as a Regulatory Affairs Specialist?
Regulatory Affairs Specialists state the following job skills are important in their day-to-day work.
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.
Other Regulatory Affairs Specialist Job Titles
- Quality Assurance Documentation Specialist
- Regulatory Affairs Specialist
- Regulatory Affairs Associate
- Regulatory Affairs Strategy Specialist
- Compliance Analyst
Are There Job Opportunities 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. The BLS estimates 25,900 yearly job openings in this field.
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.
Average Regulatory Affairs Specialists Salary
Regulatory Affairs Specialists make between $38,320 and $109,650 a year.
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 |
What Tools do Regulatory Affairs Specialists Use?
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
Becoming a Regulatory Affairs Specialist
What kind of Regulatory Affairs Specialist requirements are there?
How many years of work experience do I need?
Where Regulatory Affairs Specialists Are Employed
The table below shows some of the most common industries where those employed in this career field work.
References:
More about our data sources and methodologies.
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