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What is a regulatory affairs director and how to become one
Starting a new company requires regulatory paperwork. Instead of doing this yourself, you can hire a regulatory affairs director to do it. A regulatory affairs director fills all the necessary applications and handles government interactions. They do this to ensure the completion of the regulation process for products that require the government's approval. Basically, the regulatory director ensures the company is regulation compliant.
The director serves as the point person in communicating with regulatory bodies to obtain necessary licenses for all projects and products. They also prepare an overall regulatory strategy that forecasts and prevents problems related to non-compliance with any regulation.
A regulatory affairs director must have at least a bachelor's degree and five or more years of managerial experience to be qualified for this position.
Avg. Salary $122,617
Avg. Salary $59,228
American Indian and Alaska Native 0.66%
Asian 8.66%
Black or African American 7.53%
Hispanic or Latino 12.61%
Unknown 4.69%
White 65.85%
Genderfemale 44.21%
male 55.79%
Age - 47American 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 - 47Stress level is high
7.1 - high
Complexity level is challenging
7 - challenging
Work life balance is fair
6.4 - fair
Regulatory affairs director career paths
Key steps to become a regulatory affairs director
Explore regulatory affairs director education requirements
Start to develop specific regulatory affairs director skills
Skills Percentages Regulatory Affairs 12.62% FDA 8.21% Regulatory Strategy 7.11% Global Regulatory 6.98% Regulatory Agencies 6.76% Complete relevant regulatory affairs director training and internships
Accountants spend an average of 3-6 months on post-employment, on-the-job training. New regulatory affairs directors 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 director based on U.S. Bureau of Labor Statistics data and data from real regulatory affairs director resumes.Research regulatory affairs director duties and responsibilities
- Implement ISO 9001complaint quality system and manage surveillance audits.
- Assess state Medicaid manage care contract and vendor contract requirements to create compliance audit plans.
- Manage customer complaints, including MDR submissions, maintenance of complaint database, and correspondence with the customer.
- Provide subject matter expertise involving applicable FDA regulations, EU directives, ISO and ASTM standards, and applicable ICH guidelines.
Get regulatory affairs director experience
Generally, it takes 2-4 years to become a regulatory affairs director. The most common roles before becoming a regulatory affairs director include regulatory affairs manager, regulatory affairs specialist team lead and director.Prepare your regulatory affairs director resume
When your background is strong enough, you can start writing your regulatory affairs director 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 director 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 director resume templates
Build a professional regulatory affairs director 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 director resume.
Apply for regulatory affairs director jobs
Now it's time to start searching for a regulatory affairs director 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 director job
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Average regulatory affairs director salary
The average regulatory affairs director salary in the United States is $122,617 per year or $59 per hour. Regulatory affairs director salaries range between $81,000 and $184,000 per year.
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Updated January 8, 2025
