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), RA QA Director (Regulatory Affairs Quality Assurance Director), RA VP (Regulatory Affairs Vice President), Regulatory Director, Vaccine RA Director (Vaccine Regulatory Affairs Director), CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager), International Regulatory Affairs Specialist, RA and Compliance Director (Regulatory Affairs and Compliance Director), Regulatory Affairs Executive, Regulatory Affairs Project Manager (Regulatory Affairs PM), Regulatory Manager, Regulatory Operations Manager (Regulatory Ops Manager), Regulatory Oversight Manager, Regulatory Process Manager, Regulatory Program Manager, Regulatory Reporting Manager, Regulatory Reports Manager

This is a career information profile, not an advertised job opening.

What the worker does

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.

Skills, machines and equipment

Writing
Reading Comprehension
Active Listening
Speaking
Critical Thinking
Complex Problem Solving
Judgment and Decision Making
Systems Analysis
Systems Evaluation
Monitoring
Time Management
Active Learning

Education and training

Most frequently reported education in the O*NET survey: Bachelor's Degree (73.91% of responses). This is survey context, not a universal hiring requirement. Most of these occupations require a four-year bachelor's degree, but some do not.

O*NET Job Zone 4: Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training. 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. This is broad occupational preparation context; confirm the requirements for a specific employer or apprenticeship.

Apprenticeships

Ask an employer or registered apprenticeship sponsor about current programs, eligibility, training and pay. A career profile does not confirm that a program is available.

Salary reference

102,880–186,300 USD per year · United States · 2025. Source: BLS OEWS via O*NET · 25th–75th percentiles · SOC 11-9199.

Occupational-group wage references are not guaranteed pay for this specialty or an employer's offer.

Career advancement

Suggested development: build experience in safety leadership, staff development, budgeting, and continuous improvement before seeking responsibility for a larger department or plant.
Possible next steps include broader operations or multi-site leadership; vacancies, qualifications, and advancement are employer-specific, not guaranteed.

How Do I Get This Job?

Review the skills and responsibilities above.
Most frequently reported education in the O*NET survey: Bachelor's Degree (73.91% of responses). This is survey context, not a universal hiring requirement. Most of these occupations require a four-year bachelor's degree, but some do not.
O*NET Job Zone 4: Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training. 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. This is broad occupational preparation context; confirm the requirements for a specific employer or apprenticeship.
Compare real openings and confirm requirements directly with the employer.

View available jobs — availability is not guaranteed; sample listings are not real openings.

Related career information

Sources and limitations

O*NET® 31.0 Database, U.S. Department of Labor, Employment and Training Administration, under CC BY 4.0. ShopFloor adapted occupational grouping, selected manufacturing-relevant occupations, and retained seven legacy guide titles. Specialties and alternative titles are grouped under O*NET occupations; these occupations can also occur outside manufacturing. Source: https://www.onetcenter.org/database.html. No wage, vacancy, certification, or video data is implied. ShopFloor advancement suggestions are general editorial guidance, not O*NET findings or guaranteed career progression. BLS wage ranges, when available, are national 25th–75th percentiles for the source occupational grouping, across industries; they are not local, apprentice, entry-level, or specialty-specific offers.

Regulatory Affairs Managers