Life As 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.
What Do Regulatory Affairs Specialists Do On a Daily Basis?
- Recommend changes to company procedures in response to changes in regulations or standards.
- Develop or track quality metrics.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
What a Regulatory Affairs Specialist Should Know
Below is a list of the skills most Regulatory Affairs Specialists say are important on the job.
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
- Quality Assurance Specialist
- Compliance Analyst
- Drug Regulatory Affairs Specialist
- Research Quality Assurance Analyst
- Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist)
What Kind of Regulatory Affairs Specialist Job Opportunities Are There?
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. 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.
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|
|District of Columbia||$93,240|
Tools & Technologies Used by Regulatory Affairs Specialists
Although they’re not necessarily needed for all jobs, the following technologies are used by many Regulatory Affairs Specialists:
- 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
What education or degrees do I need to become 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.
More about our data sources and methodologies.
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