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Regulatory Affairs Managers

The occupation Regulatory Affairs Managers covers people who plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures. O*NET rates it as considerable preparation, which usually means a bachelor’s degree plus a period of work experience. It leans on writing, reading comprehension, and speaking. Expect to develop regulatory strategies and implementation plans for the preparation and submission of new products. The strongest interest signal is Enterprising (6.6 of 7), then Conventional (5.7) and Investigative, which gives it the code ECI. You may also need to review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. People who want leading, persuading and making business decisions usually fit better here than those who need creative work with room for original expression.

What they do

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Main tasks

  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.

Skills

  • Writing
  • Reading Comprehension
  • Speaking
  • Active Listening
  • Critical Thinking
  • Systems Evaluation

Who this career fits

May suit you if

  • You like taking the lead and making the call.
  • You like clear rules and getting the details right.
  • You are ready to spend around four years on a degree, then build experience.
  • You are comfortable relying on writing and reading comprehension.

May not suit you if

  • You would rather not persuade, sell or manage other people.
  • You need creative expression to be a big part of your day. Artistic rates 1.3 out of 7 here.
  • You want to avoid a four-year degree or its equivalent.

Interest profile

O*NET rates each occupation from 1 to 7 on six interest types. The code ECI takes the three highest, and Enterprising comes first here.

Preparation

Considerable preparation. Most jobs here ask for a bachelor’s degree, and employers usually expect a few years of related experience as well.

Most-reported requirement in the O*NET survey: Bachelor's Degree. This reflects what workers reported most often and is not a legal minimum. Licensing rules can differ by state or industry, so confirm what applies where you plan to work.

Also called

  • CMC Director (Chemistry, Manufacturing, and Controls Director)
  • Compliance Director
  • Global RA Director (Global Regulatory Affairs Director)
  • Global RA Manager (Global Regulatory Affairs Manager)
  • RA Director (Regulatory Affairs Director)

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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.