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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.
On the job, you would:
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.

Knowledge

Arts and Humanities
  • English language
Safety and Government
  • law and government
Business
  • administrative services

Skills

Basic Skills
  • reading work related information
  • thinking about the pros and cons of different ways to solve a problem
Problem Solving
  • noticing a problem and figuring out the best way to solve it
People and Technology Systems
  • figuring out how a system should work and how changes in the future will affect it
  • thinking about the pros and cons of different options and picking the best one

Abilities

Verbal
  • read and understand what is written
  • communicate by writing
Ideas and Logic
  • notice when problems happen
  • make general rules or come up with answers from lots of detailed information

Personality

People interested in this work like activities that include data, detail, and regular routines.
They do well at jobs that need:
  • Integrity
  • Attention to Detail
  • Dependability
  • Adaptability/Flexibility
  • Analytical Thinking
  • Stress Tolerance

Technology

You might use software like this on the job:

Document management software
  • Adobe Systems Adobe Acrobat software
  • Atrion Intelligent Authoring
Analytical or scientific software
  • Analyse-it Software
  • Statistical software
Data base user interface and query software
  • FileMaker Pro software
  • Microsoft Access

Education

Education: (rated 4 of 5)
bachelor's degree
usually needed

Get started on your career:

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Job Outlook

Bright Outlook
New job opportunities are very likely in the future.
Salary
$64,340
per year, on average
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See more details at O*NET OnLine about regulatory affairs specialists.