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.
Life As a Regulatory Affairs Specialist: What Do They Do?
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Monitor national or international legislation on ozone-depleting substances or global warming.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
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.
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
- Regulatory Affairs Associate
- Regulatory Affairs Analyst
- Regulatory Services Consultant
- Compliance Specialist
- Quality Assurance Documentation Coordinator
Job Outlook for Regulatory Affairs Specialists
In 2016, there was an estimated number of 288,300 jobs in the United States for Regulatory Affairs Specialist. 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.
Salary for a Regulatory Affairs Specialist
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|
|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 Visio
- Microsoft SharePoint
- Structured query language SQL
- Microsoft Dynamics
- FileMaker Pro
- Microsoft SQL Server
- Medical procedure coding software
- Qlik Tech QlikView
How do I Become a Regulatory Affairs Specialist?
Education needed to be a Regulatory Affairs Specialist:
What work experience do I need to become a Regulatory Affairs Specialist?
Regulatory Affairs Specialists Sector
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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