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Regulatory Affairs Managers

  • Business, Management and Administration

Tasks

What tasks do Regulatory Affairs Managers perform?

  • 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.


Knowledge

What do Regulatory Affairs Managers 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.

  • Administration and Management

    Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.


Skills

What skills do Regulatory Affairs Managers need?

  • Writing

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

  • Reading Comprehension

    Understanding written sentences and paragraphs in work-related documents.

  • Speaking

    Talking to others to convey information effectively.



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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.