Regulatory Affairs Specialists
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.
Also called: Drug Regulatory Affairs Specialist, QA Documentation Coordinator (Quality Assurance Documentation Coordinator), QA Documentation Specialist (Quality Assurance Documentation Specialist), QA Specialist (Quality Assurance Specialist), RA Analyst (Regulatory Affairs Analyst), RA Associate (Regulatory Affairs Associate)
Median pay
$80,730
Pay for the broader BLS group “Compliance Officers”
Pay range (10th–90th)
$48,220 – $133,720
People employed
417,070
Whole BLS group
Holland code
CEI
Conventional · Enterprising · Investigative
Updated October 2026 · Data: O*NET 31.0 and BLS OEWS May 2025 · How we match careers
Is this career right for you?
These are the things that stand out in this job compared with other U.S. jobs (O*NET 31.0 work context). Answer honestly.
- 1.Are you comfortable sitting at a desk most of the day?
- 2.Do you prefer working indoors?
- 3.Do you want a job with little physical risk?
- 4.Are you comfortable following clear instructions?
- 5.Would you rather not deal with customers or the public?
- 6.Do you want to lead or coordinate other people’s work?
The hard parts
- Tight deadlines are common
Regulatory Affairs Specialists pay by state
Highest-paying states
Annual median pay by state (50 states and DC with published data). Source: BLS OEWS May 2025, for the broader group “Compliance Officers”.
What regulatory affairs specialists do
- 01Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- 02Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- 03Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- 04Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- 05Coordinate efforts associated with the preparation of regulatory documents or submissions.
- 06Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Skills that matter most
- Speaking
- Writing
- Critical Thinking
- Reading Comprehension
- Active Listening
- Active Learning
Knowledge
- English Language
- Law and Government
- Administration and Management
- Administrative
- Computers and Electronics
Work styles that stand out
- Dependability
- Attention to Detail
- Integrity
- Cautiousness
- Intellectual Curiosity
Education and first steps
Share of workers by required education, as reported to O*NET.
How people get started
- Usually needs a bachelor's degree (O*NET Job Zone 4).
- Related work experience: over 2 years, up to and including 4 years.
- On-the-job training: over 3 months, up to and including 6 months.
- A certification can help.
Most common answers from O*NET 31.0 Education, Training and Experience.
Interest fit (Holland code)
O*NET occupational interest scores, scale 1–7. Take the Free Career Test to compare with your own.
Career changes
Change from regulatory affairs specialists
- Regulatory Affairs Managers95% · group pay
- Compliance Managers89% · group pay
- Document Management Specialists86% · group pay
- Clinical Data Managers82% · group pay
- Financial Examiners79% · —
Change into regulatory affairs specialists
Jobs whose skills carry over best (skill match, their median pay).
- Regulatory Affairs Managers95% · $141,900
- Compliance Managers89% · $141,900
- Clinical Data Managers82% · $120,230
- Document Management Specialists79% · $116,580
- Financial Examiners76% · $94,160
Majors that lead here
- Environmental Studies
- Environmental Science
- Environmental/Natural Resources Law Enforcement and Protective Services
- Energy and Environmental Policy
- Environmental Geosciences
- Suspension and Debarment Investigation
- Medical Staff Services Technology/Technician
- Regulatory Science/Affairs
- Patient Safety and Healthcare Quality
- Human Resources Management/Personnel Administration, General
- Labor and Industrial Relations
From the NCES CIP 2020 to SOC 2018 crosswalk.