Regulatory Affairs Managers

Career Overview

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

Also Known As

• Compliance Director
• Global RA Manager (Global Regulatory Affairs Manager)
• RA Director (Regulatory Affairs Director)
• RA Manager (Regulatory Affairs Manager)

Alternate Job Titles

• CMC Director (Chemistry, Manufacturing, and Controls Director)
• CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager)
• Compliance Director
• Global RA Director (Global Regulatory Affairs Director)
• Global RA Manager (Global Regulatory Affairs Manager)
• International Regulatory Affairs Specialist
• RA and Compliance Director (Regulatory Affairs and Compliance Director)
• RA Director (Regulatory Affairs Director)
• RA Manager (Regulatory Affairs Manager)
• RA QA Director (Regulatory Affairs Quality Assurance Director)
• RA VP (Regulatory Affairs Vice President)
• Regulatory Affairs Executive
• Regulatory Affairs Project Manager (Regulatory Affairs PM)
• Regulatory Director
• Regulatory Manager

What You'll Do

In this role, your typical responsibilities include:

• 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.

Emerging Responsibilities

As this field evolves, you may also:

• Develop and review regulatory strategies, development plans, and implementation plans for the preparation and submission of new products.

Knowledge You'll Use

You'll need solid knowledge in these areas:

• English Language
• Law and Government
• Administration and Management

Essential Skills

Success in this career requires strong skills in:

1. Writing
2. Reading Comprehension
3. Active Listening
4. Speaking
5. Critical Thinking
6. Complex Problem Solving
7. Judgment and Decision Making
8. Systems Analysis
9. Systems Evaluation
10. Monitoring

Key Abilities

This career requires key abilities in:

• Written Expression
• Oral Comprehension
• Oral Expression
• Written Comprehension
• Inductive Reasoning
• Deductive Reasoning
• Speech Recognition
• Near Vision
• Speech Clarity
• Problem Sensitivity

Work Style

People who excel in this career typically demonstrate:

• Attention to Detail
• Integrity
• Dependability
• Cautiousness
• Leadership Orientation

What Matters in This Career

This career tends to satisfy these work values:

• Achievement
• Independence
• Working Conditions
• Support
• Recognition

Education & Preparation

Typical Education: Bachelor's Degree

Related Work Experience Needed: Over 2 years, up to and including 4 years

On-the-Job Training: Over 6 months, up to and including 1 year

Education Details: Most of these occupations require a four-year bachelor's degree, but some do not.

Experience Required: A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.

Technology You'll Use

Popular Technologies & Software

• Adobe Acrobat
• Microsoft Access
• Microsoft Excel
• Microsoft Office software
• Microsoft Outlook
• Microsoft PowerPoint
• Microsoft Project
• Microsoft SharePoint
• Microsoft Visio
• Microsoft Windows

Tools & Equipment

• Computer laser printers
• Desktop computers
• Laptop computers
• Laser facsimile machines
• Multi-line telephone systems
• Personal computers
• Photocopying equipment

Work Environment

• E-Mail
• Work With or Contribute to a Work Group or Team
• Spend Time Sitting
• Face-to-Face Discussions with Individuals and Within Teams
• Telephone Conversations

Salary & Job Market

Wages reported for the broader Managers, All Other occupational group (BLS 2024), which includes Regulatory Affairs Managers.

Salary Percentile	Annual Wage
Entry-Level (10th percentile)	$68,860
Median	$136,550
Top Earners (90th percentile)	$227,590

Workers Employed Nationally: 630,980

Related Careers

If you're interested in this career, you might also consider:

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Occupational data sourced from the O*NET OnLine database, developed by the U.S. Department of Labor, Employment and Training Administration. Wage data from the U.S. Bureau of Labor Statistics Occupational Employment and Wage Statistics (OEWS), 2024.