Regulatory Affairs Specialists

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Career Profile

Regulatory Affairs Specialists

What they do

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, Regulatory Affairs Analyst (RA Analyst), Regulatory Affairs Associate (RA Associate), Regulatory Affairs Consultant (RA Consultant), Regulatory Affairs Specialist (RA Specialist), Regulatory Affairs Strategist (RA Strategist), Regulatory Engineer, Regulatory Services Consultant, Regulatory Specialist, Regulatory Submissions Associate, Drug Regulatory Affairs Specialist, Regulatory Affairs Analyst (RA Analyst), Regulatory Affairs Associate (RA Associate), Regulatory Affairs Consultant (RA Consultant), Regulatory Affairs Specialist (RA Specialist), Regulatory Affairs Strategist (RA Strategist), Regulatory Engineer, Regulatory Services Consultant, Regulatory Specialist, Regulatory Submissions Associate

Job Data & Employment

*National data provided by O*NET & BLS
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$48,220
Starting Salary (2025)
$80,730
Median Salary (2025)
3.0%
Projected Job Growth
417,070
Employment (2025)

Typical Tasks

Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Coordinate efforts associated with the preparation of regulatory documents or submissions.
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

What kind of work is this?

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

What personality traits do you need to succeed?

Attention to Detail
Integrity
Dependability
Cooperation
Persistence
Analytical Thinking

What key skills are needed for this job?

Writing
Active Listening
Speaking
Judgment and Decision Making
Reading Comprehension
Critical Thinking

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.
Biology
Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.

Common Activities

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.
Getting Information
Observing, receiving, and otherwise obtaining information from all relevant sources.
Communicating with Supervisors, Peers, or Subordinates
Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.

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 80%
  • Master's degree 10%
  • Post-doctoral training 5%
  • Post-baccalaureate certificate 5%
Source: O*NET Education, Training & Experience data

Related Careers

Regulatory Affairs Managers
Compliance Managers
Environmental Compliance Inspectors
Government Property Inspectors and Investigators
Quality Control Systems 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.