Regulatory Affairs Specialists

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

Also called: Drug Regulatory Affairs Specialist, QA Specialist (Quality Assurance Specialist), RA Analyst (Regulatory Affairs Analyst), RA Associate (Regulatory Affairs Associate), RA Consultant (Regulatory Affairs Consultant), RA Strategist (Regulatory Affairs Strategist), Regulatory Consultant, Regulatory Services Consultant, Regulatory Specialist, Regulatory Submissions Associate, QA Documentation Coordinator (Quality Assurance Documentation Coordinator), QA Documentation Specialist (Quality Assurance Documentation Specialist), RA Coordinator (Regulatory Affairs Coordinator), Regulatory Affairs Scientist (RA Scientist), Regulatory Analyst, Regulatory Compliance Associate, Regulatory Compliance Specialist, Regulatory Coordinator, Regulatory Reporting Analyst, Regulatory Scientist, Research Compliance Specialist, Research QA Analyst (Research Quality Assurance Analyst), Research QA Specialist (Research Quality Assurance Specialist), Risk and Compliance Analyst

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

What the worker does

Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
Coordinate efforts associated with the preparation of regulatory documents or submissions.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
Prepare or maintain technical files as necessary to obtain and sustain product approval.
Coordinate recall or market withdrawal activities as necessary.
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.

Skills, machines and equipment

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

Education and training

Most frequently reported education in the O*NET survey: Bachelor's Degree (80.00% 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

61,280–109,010 USD per year · United States · 2025. Source: BLS OEWS via O*NET · 25th–75th percentiles · SOC 13-1041.

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

Career advancement

Develop reliable production, safety, quality, and equipment skills; explore additional processes, senior specialist, or team-lead responsibilities relevant to your workplace.
Ask employers which demonstrated skills, education, or credentials are needed for the next role. Related careers are exploration options, not automatic promotions.

How Do I Get This Job?

Review the skills and responsibilities above.
Most frequently reported education in the O*NET survey: Bachelor's Degree (80.00% 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 Specialists