Regulatory Affairs Managers

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Career Profile

Regulatory Affairs Managers

What they do

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), RA QA Director (Regulatory Affairs Quality Assurance Director), RA VP (Regulatory Affairs Vice President), Regulatory Director, Vaccine RA Director (Vaccine Regulatory Affairs Director), 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), RA QA Director (Regulatory Affairs Quality Assurance Director), RA VP (Regulatory Affairs Vice President), Regulatory Director, Vaccine RA Director (Vaccine Regulatory Affairs Director)

Job Data & Employment

*National data provided by O*NET & BLS
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$74,300
Starting Salary (2025)
$141,900
Median Salary (2025)
4.5%
Projected Job Growth
622,190
Employment (2025)

Typical Tasks

Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
Contribute to the development or implementation of business unit strategic and operating plans.
Develop and maintain standard operating procedures or local working practices.
Develop regulatory strategies and implementation plans for the preparation and submission of new products.
Direct documentation efforts to ensure compliance with domestic and international regulations and standards.

A day in the life

What kind of work is this?

Enterprising
Business based Work
Conventional
Organized, Procedural Work
Investigative
Studying, Research based work

What personality traits do you need to succeed?

Integrity
Attention to Detail
Dependability
Stress Tolerance
Leadership
Analytical Thinking

What key skills are needed for this job?

Writing
Speaking
Reading Comprehension
Critical Thinking
Monitoring
Coordination

Expected Knowledge

English Language
Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Law and Government
Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
Administration and Management
Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.

Common Activities

Getting Information
Observing, receiving, and otherwise obtaining information from all relevant sources.
Evaluating Information to Determine Compliance with Standards
Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
Making Decisions and Solving Problems
Analyzing information and evaluating results to choose the best solution and solve problems.

Education & Preparation

Some occupations may require additional education, advanced degrees, and years of experience in the field.
Talk to your support team on campus about this career pathway and additional degree information.
Job Zone 4

Considerable Preparation Needed

Education

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

Experience

A considerable amount of work-related skill, knowledge, or experience is needed for these occupations.

Training

Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.

Typical Education Required

Education a new hire may need

  • Bachelor's degree 75%
  • Master's degree 14%
  • Post-master's certificate 4%
  • Professional degree 4%
  • Associate's degree 4%
Source: O*NET Education, Training & Experience data

Related Careers

Regulatory Affairs Specialists
Compliance Managers
Management Analysts
Clinical Data Managers

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*Data on career profiles are based on information supplied by the O*NET Program, sponsored by U.S. Department of Labor, Employment, and Training Administration.