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Regulatory Affairs Specialists

Under the title Regulatory Affairs Specialists, workers coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. O*NET rates it as considerable preparation, which usually means a bachelor’s degree plus a period of work experience. It leans on writing, speaking, and reading comprehension. The job can ask you to coordinate, prepare, or review regulatory submissions for domestic or international projects. Its interest code is CEI. Conventional leads at 6.3 out of 7, so expect orderly work with data, records and clear procedures, with Enterprising next at 4.5. Expect to communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. People who want orderly work with data, records and clear procedures usually fit better here than those who need creative work with room for original expression.

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.

Main tasks

  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

Skills

  • Writing
  • Speaking
  • Reading Comprehension
  • Judgment and Decision Making
  • Critical Thinking
  • Active Listening

Who this career fits

May suit you if

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

May not suit you if

  • You get restless with routine, records and exact procedures.
  • You need creative expression to be a big part of your day. Artistic rates 1.0 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 CEI takes the three highest, and Conventional 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

  • Drug Regulatory Affairs Specialist
  • QA Specialist (Quality Assurance Specialist)
  • RA Analyst (Regulatory Affairs Analyst)
  • RA Associate (Regulatory Affairs Associate)
  • RA Consultant (Regulatory Affairs Consultant)

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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.