CAREER

Regulatory Affairs Specialists

Overview

Salary Median (2020)

$71,100

Projected Job Growth (2019-2029)

+4.6% (slower than the average)

Most Common Level of Education

Bachelor's degree

Career

What Regulatory Affairs Specialists 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.

Other Job Titles Regulatory Affairs Specialists May Have

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

How Leaders Describe a Typical Day at Work

Process Coordinator ,

Capital One

Most of what they would see is me sitting in front of a computer! A great day is where I get into a great flow and am able to get a large amount of work done.

Principal Operations Production Coordinator ,

Capital One

I pull reports, review them for errors, and send the errors to the business for remediation. The errors are then analyzed for trends to share with the business and suggest training/coaching options.


Tasks & Responsibilities May Include

  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.

This page includes information from theO*NET 26.1 Databaseby the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA). Used under theCC BY 4.0license. O*NET® is a trademark of USDOL/ETA.