Business Operations Specialists

How to become a Regulatory Affairs Specialist

Official title: Regulatory Affairs Specialists

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

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.

Main tasks

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.

How to become one

Compliance officers typically need a bachelor's degree to enter the occupation. They often receive training on the job. Employers may prefer or require candidates to have experience related to the position.

Typical education to start: Bachelor's degree

Read the full guide from the U.S. Bureau of Labor Statistics

Ways in

Apprenticeship: Regulatory Affairs Specialist.
College: Science degrees, Offered by 36 universities in the US

Pay · Outlook · AI and this job

Median pay: $80,730 a year The middle half earn $61,280 to $109,010.
About 436,400 people work in this job now, and about 453,100 are projected by 2035. (+3.8%)
People already use generative AI for some of this work. Microsoft Research rates its AI applicability as medium.

Questions people ask

How do I become a Regulatory Affairs Specialist?

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

Median full-time pay is $80,730 a year (U.S. Bureau of Labor Statistics). The middle half earn $61,280 to $109,010.

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

Yes. Employment is projected to grow 4% by 2035, from about 436,400 to about 453,100 people (U.S. Bureau of Labor Statistics).

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

Usually. 65% of people in this job hold a bachelor's degree or higher.

Will AI change the work of a Regulatory Affairs Specialist?

People already use generative AI for some of this work. Microsoft Research rates its AI applicability as medium.

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 Outlook Handbook (2025-35 edition (published 2026-08-27)), Public domain (BLS); photographs excluded, 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.