Business & Finance
Regulatory Affairs Specialists
Also called: Drug Regulatory Affairs Specialist, QA Specialist (Quality Assurance Specialist), RA Analyst (Regulatory Affairs Analyst), RA Associate (Regulatory Affairs Associate)
US median pay
$80,730
per year, 2025
Job growth 2025–35
+3.8%
about average or slower
Openings a year (US)
32,700
436,400 employed
Typical entry education
Bachelor's degree
Preparation 4/5 · Considerable preparation
What this job is
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.
What they do 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.
- Coordinate recall or market withdrawal activities as necessary.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
Skills and knowledge that matter most
Skills
- Judgment and Decision Making4.0/5
- Systems Analysis3.9/5
- Complex Problem Solving3.9/5
- Systems Evaluation3.8/5
- Coordination3.4/5
- Time Management3.2/5
- Social Perceptiveness3.1/5
- Persuasion3.0/5
Knowledge
- 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
Importance rated by people working in the job (1 = not important, 5 = extremely important).
Education and preparation
Preparation level 4 of 5 — Considerable preparation. Usually a bachelor's degree and several years of related experience.
Typical entry education (BLS): Bachelor's degree.
Highest education of people in this job:
- Bachelor's degree80%
- Master's degree10%
Who this job suits
Mostly Conventional
Organising data, details and procedures
Enterprising
Leading, persuading and starting things
Investigative
Ideas, research and solving problems
Based on the Holland (RIASEC) interest profile for this occupation.