All About Regulatory Affairs Specialists
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.
Regulatory Affairs Specialist Responsibilities
- 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.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Write or update standard operating procedures, work instructions, or policies.
- Recommend changes to company procedures in response to changes in regulations or standards.
What Skills Do You Need to Work as a Regulatory Affairs Specialist?
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.
Related Job Titles
- Research Compliance Specialist
- Regulatory Affairs Strategy Specialist
- Compliance Specialist
- Product Safety Specialist
- Compliance Analyst
Regulatory Affairs Specialist Employment Estimates
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. 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.
What is the Average Salary of a Regulatory Affairs Specialist
The typical yearly salary for Regulatory Affairs Specialists is somewhere 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|
|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
What education or degrees do I need to become a Regulatory Affairs Specialist?
How many years of work experience do I need?
Where Regulatory Affairs Specialists Work
The table below shows the approximate number of Regulatory Affairs Specialists employed by various industries.
More about our data sources and methodologies.
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