Regulatory Affairs Specialists
SOC code 13-1041 · O*NET-SOC 13-1041.07 · Considerable preparation needed · Business and finance
Regulatory Affairs Specialists pay
U.S. national figures, May 2025 BLS survey · How we got this number
Median pay
$80,730
a year
Hourly
$38.81
per hour
The solid band is the middle 50% of workers; the bar spans the 10th to 90th percentile.
Average pay
$88,400
$42.50 per hour
Middle 50%
$61,280 – $109,010
25th to 75th percentile
Full spread
$48,220 – $133,720
10th to 90th percentile
People employed
417,070
nationwide
National U.S. figure, May 2025. Local pay can be higher or lower.
These pay and employment figures are for the broader BLS group “Compliance Officers”, not this job alone.
- 10th percentile
- $48,220
- $23.18/hr
- 25th percentile
- $61,280
- $29.46/hr
- Median percentile
- $80,730
- $38.81/hr
- 75th percentile
- $109,010
- $52.41/hr
- 90th percentile
- $133,720
- $64.29/hr
Job outlook · federal projection 2024–34
+3%
Growing about as fast as average
418,000
jobs in 2024
430,300
projected for 2034
About 12,300 more jobs
U.S. Bureau of Labor Statistics employment projections, 2024–34. Projections describe the broader occupation group and are estimates, not guarantees.
What does a regulatory affairs specialist do?
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.
The tasks that matter most day to day
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
How to become a regulatory affairs specialist
Most people in this role hold bachelor's degree — 80% of workers surveyed reported it as their level of education.
Preparation level: zone 4 — Considerable preparation needed
- Education
- Most of these occupations require a four-year bachelor's degree, but some do not.
- Experience
- A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.
- Training
- Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
Education reported by people doing this job
- Bachelor's Degree80%
- Master's Degree10%
- Post-Baccalaureate Certificate5%
- Post-Doctoral Training5%
Common questions
How much does a regulatory affairs specialist earn?
The national median is $80,730 a year. The full range runs from $48,220 at the 10th percentile to $133,720 at the 90th — entry pay sits closer to the lower figure, and experience, licensing and specialisation move you up the range.
Can you become a regulatory affairs specialist without a degree?
Not usually — this occupation sits in preparation zone 4, where the typical entry route is most of these occupations require a four-year bachelor's degree, but some do not. The education breakdown above shows what people in the role actually reported.
Is regulatory affairs specialist in demand?
Federal projections expect employment to grow by about 3% between 2024 and 2034 — growing about as fast as average. Openings also come from people retiring or changing jobs, which the growth figure does not count.
Skills and knowledge you need
Core skills
- Reading Comprehension4.0/5
- Active Listening4.0/5
- Writing4.0/5
- Speaking4.0/5
- Critical Thinking4.0/5
- Active Learning3.8/5
Knowledge areas
- English Language4.2/5
- Law and Government3.9/5
- Administration and Management3.4/5
- Administrative3.2/5
- Computers and Electronics3.2/5
- Medicine and Dentistry2.7/5
- Engineering and Technology2.7/5
- Mathematics2.7/5
Transferable strengths: Judgment and Decision Making, Complex Problem Solving, Systems Analysis, Systems Evaluation.