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Regulatory Affairs Managers

Also called: Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Affairs Director, Regulatory Affairs Manager

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What they do:
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
On the job, you would:
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.


Arts and Humanities
  • English language
Safety and Government
  • law and government
  • medicine and dentistry
  • management


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


  • read and understand what is written
  • communicate by speaking
Ideas and Logic
  • notice when problems happen
  • use rules to solve problems


People interested in this work like activities that include leading, making decisions, and business.
They do well at jobs that need:
  • Integrity
  • Attention to Detail
  • Dependability
  • Initiative
  • Leadership
  • Stress Tolerance


You might use software like this on the job:

Document management software
  • Adlib Express
  • Adobe Systems Adobe Acrobat Hot Technology
Compliance software
  • MediRegs Regulation and Reimbursement Suite
  • Thomson Reuters Liquent InSight Suite
Data base user interface and query software
  • Microsoft Access Hot Technology
  • Structured query language SQL Hot Technology


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

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See more details at O*NET OnLine about regulatory affairs managers.