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.
Daily Life Of a Regulatory Affairs Specialist
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Develop or track quality metrics.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
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Regulatory Affairs Specialist Skills
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
- Regulatory Affairs Specialist
- Research Quality Assurance Specialist
- Research Compliance Specialist
- Clinical Quality Assurance Associate
- Clinical Quality Assurance Specialist
Regulatory Affairs Specialist Job Outlook
There were about 288,300 jobs for Regulatory Affairs Specialist in 2016 (in the United States). 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.
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.
Do Regulatory Affairs Specialists Make A Lot Of Money?
The average yearly salary of a Regulatory Affairs Specialist ranges between $38,320 and $109,650.
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 to Become a Regulatory Affairs Specialist
What education is needed to be a Regulatory Affairs Specialist?
How Long Does it Take to Become a Regulatory Affairs Specialist?
Regulatory Affairs Specialists Sector
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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