What You Need to Know About Regulatory Affairs Specialist
Job Description & Duties 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.
A Day in the Life of a Regulatory Affairs Specialist
- Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
- Compile and maintain regulatory documentation databases or systems.
- Develop or conduct employee regulatory training.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
What a Regulatory Affairs Specialist Should Know
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
- Compliance Consultant
- Product Safety Specialist
- Quality Assurance Documentation Coordinator
- Regulatory Submissions Associate
- Compliance Specialist
Regulatory Affairs Specialist Employment Estimates
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. There will be an estimated 25,900 positions for Regulatory Affairs Specialist per 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.
What is the Average Salary of a Regulatory Affairs Specialist
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|
|District of Columbia||$93,240|
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
- Microsoft Project
- Adobe Systems Adobe Acrobat
- Microsoft Visio
- Microsoft SharePoint
- Structured query language SQL
- Microsoft Dynamics
- FileMaker Pro
- Microsoft SQL Server
- Medical procedure coding software
- Qlik Tech QlikView
How to Become a Regulatory Affairs Specialist
Education needed to be a Regulatory Affairs Specialist:
How Long Does it Take to Become a Regulatory Affairs Specialist?
Who Employs Regulatory Affairs Specialists?
The table below shows some of the most common industries where those employed in this career field work.
More about our data sources and methodologies.
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