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Regulatory Affairs Specialists

  • Government and Public Administration

Tasks

What tasks do Regulatory Affairs Specialists perform?

  • Coordinate efforts associated with the preparation of regulatory documents or submissions.

  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.


Knowledge

What do Regulatory Affairs Specialists need to know?

  • English Language

    Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

  • Law and Government

    Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.

  • Biology

    Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.


Skills

What skills do Regulatory Affairs Specialists need?

  • Writing

    Communicating effectively in writing as appropriate for the needs of the audience.

  • Speaking

    Talking to others to convey information effectively.

  • Active Listening

    Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.



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Data on career profiles are based on information supplied by the O*NET Program, sponsored by U.S. Department of Labor, Employment, and Training Administration.