Career Details for Regulatory Affairs Specialists

Regulatory Affairs Specialists

Also called:

Drug Regulatory Affairs Specialist, Regulatory Affairs Associate, Regulatory Affairs Specialist, Regulatory Submissions Associate

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.

lightbulb KNOWLEDGE

Arts and Humanities

  • English language

Safety and Government

  • law and government

Business

  • administrative services

pencil 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

trophy 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

user PERSONALITY

People interested in this work like activities that include data, detail, and regular routines.

  • Integrity
  • Attention to Detail
  • Dependability
  • Adaptability/Flexibility
  • Analytical Thinking
  • Stress Tolerance

computer TECHNOLOGY

You might use software like this on the job:

Data base user interface and query software

  • FileMaker Pro
  • Microsoft Access

Medical software

  • Healthcare common procedure coding system HCPCS
  • Medical procedure coding software

Document management software

  • Adobe Systems Adobe Acrobat
  • Atrion Intelligent Authoring

book EDUCATION

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bachelor's degree usually needed

suitcase JOB OUTLOOK

outlook
BRIGHT

New job opportunities are very likely in the future.

SALARY
$66,540


per year, on average

This career is part of the green economy!

This career is part of the green economy.
See more details at O*NET OnLine about Regulatory Affairs Specialists
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