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Career overview · SOC 11-9199

Regulatory Affairs Managers

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Also called: CMC Director (Chemistry, Manufacturing, and Controls Director) · Compliance Director · Global RA Director (Global Regulatory Affairs Director) · Global RA Manager (Global Regulatory Affairs Manager) · RA Director (Regulatory Affairs Director) · RA Manager (Regulatory Affairs Manager)

Median pay (national)
$136,550
$68,860–$227,590 (10th–90th)
Employed (US)
630,980
BLS OEWS, May 2024
Outlook 2024–34
+4.5%
~106,700 openings/yr
Typical entry
Bachelor's degree

What the numbers say

Refit analysis ·Pay for regulatory affairs managers shows an unusually wide range: the top 10% earn $227,590 versus $68,860 at the bottom 10% — 3.3x. The median of $136,550 leaves roughly 67% 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 +4.5% from 2024 to 2034 — faster than the 3% all-occupation average. Even so, BLS projects about 106,700 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, Massachusetts pays the most for this role (median $172,380, +26% vs the national median), while Puerto Rico sits lowest at $78,740 — a 119% spread for the same job title.
Refit analysis ·O*NET rates Writing, Reading Comprehension, Active Listening 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.

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

What they actually do

Core O*NET tasks for this role.

  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.

Tools & technology

  • Microsoft Excel
  • Microsoft Office software
  • Microsoft Outlook
  • Microsoft PowerPoint
  • Microsoft Visio
  • Microsoft Windows
  • SAP software
  • Structured query language SQL
  • Tableau
  • Adlib Express
  • Analyse-it
  • Aris Global Register
  • Axway eSubmissions
  • Database software
  • Datafarm a-Pulse
  • Datafarm eCTDGatekeeper

Knowledge areas

  • English Language
  • Law and Government
  • Administration and Management
  • Biology
  • Education and Training
  • Administrative
  • Chemistry
  • Computers and Electronics