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