How to become a Regulatory Affairs Manager

Official title: Regulatory Affairs Managers

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)

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

Main tasks

• 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.

How to become one

Typical education to start: Bachelor's degree

Ways in

• College: Business & Commerce degrees, Offered by 35 universities in the US
• College: Arts & Humanities degrees, Offered by 35 universities in the US

Pay · Outlook · AI and this job

• Median pay: $141,900 a year The middle half earn $102,880 to $186,300.
• About 1,338,800 people work in this job now, and about 1,404,400 are projected by 2035. (+4.9%)
• People use generative AI for relatively little of this work so far. Microsoft Research rates its AI applicability as low.

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Questions people ask

How do I become a Regulatory Affairs Manager?

Ways in include: Business & Commerce degrees; Arts & Humanities degrees.

How much does a Regulatory Affairs Manager earn in the US?

Median full-time pay is $141,900 a year (U.S. Bureau of Labor Statistics). The middle half earn $102,880 to $186,300.

Is a Regulatory Affairs Manager a growing career in the US?

Yes. Employment is projected to grow 5% by 2035, from about 1,338,800 to about 1,404,400 people (U.S. Bureau of Labor Statistics).

Do you need a degree to become a Regulatory Affairs Manager?

Not always. 58% of people in this job hold a bachelor's degree or higher. Ways in include: Business & Commerce degrees; Arts & Humanities degrees.

Will AI change the work of a Regulatory Affairs Manager?

People use generative AI for relatively little of this work so far. Microsoft Research rates its AI applicability as low.

Sources

• Microsoft Research: Working with AI: AI applicability by occupation (2025-12-22 (built on O*NET 29.0)), CC BY 4.0, retrieved 2026-10-03
• U.S. Bureau of Labor Statistics: Employment Projections (2025-35 (released 2026-08-27)), Public domain (BLS), retrieved 2026-10-03
• U.S. Bureau of Labor Statistics: Occupational Employment and Wage Statistics (May 2025), Public domain (BLS), retrieved 2026-10-03

Updated 2026-10-03

This page includes information from the O*NET 31.0 Database by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA). Used under the CC BY 4.0 license. O*NET is a trademark of USDOL/ETA.