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Career overview · SOC 13-1041

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 · Regulatory Affairs Analyst (RA Analyst) · Regulatory Affairs Associate (RA Associate) · Regulatory Affairs Consultant (RA Consultant) · Regulatory Affairs Specialist (RA Specialist) · Regulatory Affairs Strategist (RA Strategist)

Median pay (national)
$78,420
$46,230–$130,030 (10th–90th)
Employed (US)
397,770
BLS OEWS, May 2024
Outlook 2024–34
+3%
~33,300 openings/yr
Typical entry
Bachelor's degree

What the numbers say

Refit analysis ·Pay for regulatory affairs specialists shows an unusually wide range: the top 10% earn $130,030 versus $46,230 at the bottom 10% — 2.8x. The median of $78,420 leaves roughly 66% of headroom to the 90th percentile, which is where seniority, specialization, and the skills below tend to pay off.
Refit analysis ·Employment is projected to change +3% from 2024 to 2034 — about as fast as the 3% all-occupation average. Even so, BLS projects about 33,300 openings a year, mostly to replace workers who retire or change careers.
Refit analysis ·Where you work moves the number a lot. Across the 53 states with released data, District of Columbia pays the most for this role (median $103,010, +31% vs the national median), while Puerto Rico sits lowest at $46,570 — a 121% spread for the same job title.
Refit analysis ·O*NET rates Active Listening, Writing, Speaking as the highest-importance skills here — so a resume aimed at this role should lead with evidence of those, not a generic skills list. On the tools side, O*NET flags Microsoft Excel, Microsoft Office software, Microsoft Outlook, Microsoft PowerPoint as in-demand technologies for this role.

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Top skills employers ask for

Ranked by O*NET importance for this occupation.

  • Active Listening
  • Writing
  • Speaking
  • Reading Comprehension
  • Critical Thinking
  • Active Learning
  • Monitoring
  • Learning Strategies
  • Mathematics
  • Science

What they actually do

Core O*NET tasks for this role.

  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Coordinate recall or market withdrawal activities as necessary.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

Tools & technology

  • Microsoft Excel
  • Microsoft Office software
  • Microsoft Outlook
  • Microsoft PowerPoint
  • Microsoft Word
  • Microsoft SQL Server
  • Microsoft Visio
  • Microsoft Visual Basic
  • SAP software
  • Structured query language SQL
  • Yardi software
  • Analyse-it
  • Atrion Intelligent Authoring
  • DataVision
  • FileMaker Pro
  • Fund accounting software

Knowledge areas

  • English Language
  • Law and Government
  • Biology
  • Computers and Electronics
  • Administration and Management
  • Administrative
  • Chemistry
  • Medicine and Dentistry