What is a Regulatory Affairs Specialist?
Career 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.
Life As a Regulatory Affairs Specialist
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Compile and maintain regulatory documentation databases or systems.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
What Skills Do You Need to Work as a Regulatory Affairs Specialist?
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.
Critical Thinking: Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
Judgment and Decision Making: Considering the relative costs and benefits of potential actions to choose the most appropriate one.
Related Job Titles for this Occupation:
- Compliance Analyst
- Compliance Specialist
- Regulatory Services Consultant
- Quality Assurance Documentation Coordinator
- Research Quality Assurance Analyst
Job Demand for Regulatory Affairs Specialists
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. 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.
Regulatory Affairs Specialist Salary
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|
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
- Microsoft Project
- Adobe Systems Adobe Acrobat
- Microsoft SharePoint
- Microsoft Visio
- Structured query language SQL
- Microsoft Dynamics
- FileMaker Pro
- Microsoft SQL Server
- Medical procedure coding software
- Human resource management software HRMS
How do I 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 Are Employed
Regulatory Affairs Specialists work in the following industries:
More about our data sources and methodologies.
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