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What is a regulatory affairs specialist and how to become one
A regulatory affairs specialist ensures that products meet regulatory requirements. They check that products remain safe and effective, and that they comply with regulations. Regulatory affairs specialists monitor changing requirements, submit documentation to regulatory agencies, and provide guidance on regulatory matters. They may also participate in product development, clinical trials, and post-market surveillance. Overall, a regulatory affairs specialist navigates the complex landscape of regulations and ensures that companies sell and market products legally.
Avg. Salary $70,060
Avg. Salary $59,228
American Indian and Alaska Native 0.83%
Asian 8.22%
Black or African American 10.69%
Hispanic or Latino 15.67%
Unknown 4.47%
White 60.13%
Genderfemale 62.46%
male 37.54%
Age - 46American Indian and Alaska Native 3.00%
Asian 7.00%
Black or African American 14.00%
Hispanic or Latino 19.00%
White 57.00%
Genderfemale 47.00%
male 53.00%
Age - 46Stress level is manageable
7.1 - high
Complexity level is challenging
7 - challenging
Work life balance is fair
6.4 - fair
What are the pros and cons of being a regulatory affairs specialist?
Pros
High demand for regulatory affairs specialists
Opportunities for career advancement
Competitive salary and benefits package
Job stability and security
Opportunity to work remotely or from home
Cons
Long hours and overtime may be required during peak times
Risk of burnout due to high workload and job demands
Frequent interactions with government agencies may be frustrating or challenging
May require extensive travel, especially for those working in international regulatory affairs
Limited job opportunities in smaller areas or industries
Regulatory affairs specialist career paths
Key steps to become a regulatory affairs specialist
Explore regulatory affairs specialist education requirements
Start to develop specific regulatory affairs specialist skills
Skills Percentages Regulatory Affairs 10.14% FDA 8.43% Regulatory Agencies 6.58% Medical Devices 6.44% Regulatory Compliance 4.96% Complete relevant regulatory affairs specialist training and internships
Accountants spend an average of 3-6 months on post-employment, on-the-job training. New regulatory affairs specialists learn the skills and techniques required for their job and employer during this time. The chart below shows how long it takes to gain competency as a regulatory affairs specialist based on U.S. Bureau of Labor Statistics data and data from real regulatory affairs specialist resumes.Research regulatory affairs specialist duties and responsibilities
- Gather, evaluating, organizing, managing and collating information in a variety of formats.
- Manage CRO (regulatory) in support of the company's approve product in Europe.
- Manage and submit electronic EPA product registrations.
- Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
Prepare your regulatory affairs specialist resume
When your background is strong enough, you can start writing your regulatory affairs specialist resume.
You can use Zippia's AI resume builder to make the resume writing process easier while also making sure that you include key information that hiring managers expect to see on a regulatory affairs specialist resume. You'll find resume tips and examples of skills, responsibilities, and summaries, all provided by Zippi, your career sidekick.
Choose from 10+ customizable regulatory affairs specialist resume templates
Build a professional regulatory affairs specialist resume in minutes. Browse through our resume examples to identify the best way to word your resume. Then choose from 10+ resume templates to create your regulatory affairs specialist resume.
Apply for regulatory affairs specialist jobs
Now it's time to start searching for a regulatory affairs specialist job. Consider the tips below for a successful job search:
- Browse job boards for relevant postings
- Consult your professional network
- Reach out to companies you're interested in working for directly
- Watch out for job scams
How did you land your first regulatory affairs specialist job
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Average regulatory affairs specialist salary
The average regulatory affairs specialist salary in the United States is $70,060 per year or $34 per hour. Regulatory affairs specialist salaries range between $49,000 and $99,000 per year.
What am I worth?
How do regulatory affairs specialists rate their job?
Regulatory affairs specialist reviews
Challenge is different every day. I constantly learning something new for our industry and take a lot of pride in the fact that I keep us compliant .
It does get overwhelming because there are many categories of compliance company wide that fall to me.
Regulatory affairs specialist FAQs
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Updated January 8, 2025
