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Regulatory Affairs Managers

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

    Work Activities
    • Provide responses to regulatory agencies regarding product information or issues.
    • 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.
    • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
    • Manage activities such as audits, regulatory agency inspections, or product recalls.
    • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
    • Maintain current knowledge of relevant regulations, including proposed and final rules.
    • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
    • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
    • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
    • Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
    • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
    • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
    • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
    • Train staff in regulatory policies or procedures.
    • Develop and maintain standard operating procedures or local working practices.
    • Participate in the development or implementation of clinical trial protocols.
    • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
    • Contribute to the development or implementation of business unit strategic and operating plans.
    • Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
    • Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
    • Coordinate internal discoveries and depositions with legal department staff.
    • Establish regulatory priorities or budgets and allocate resources and workloads.
    • Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
    • Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
    • Monitor regulatory affairs trends related to environmental issues.
    • Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
    Skills
    • Reading Comprehension

      Understanding written sentences and paragraphs in work related documents.

    • Speaking

      Talking to others to convey information effectively.

    • Writing

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

    WorkKeys®
    Applied Math
    5
    Workplace Documents
    5
    Graphic Literacy
    5
    Abilities
    • Written Comprehension

      The ability to read and understand information and ideas presented in writing.

    • Oral Comprehension

      The ability to listen to and understand information and ideas presented through spoken words and sentences.

    • Oral Expression

      The ability to communicate information and ideas in speaking so others will understand.

    Knowledge
    • 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.

    Career Video
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    Pay
    • Ohio Annual Salary $97,600/yr
    • Typical Salary
    • Ohio Hourly Wage $46.92/hr
    • Typical Hourly Wage
    Ohio Employment Trends
    • Currently Employed 24,170
    • Yearly Projected Openings 1,930
    Typical Education
    Personality
    Enterprising: 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
    • Stress Tolerance
    • Leadership
    • Analytical Thinking
    Tools
    • Special purpose telephones
    • Personal computers
    • Notebook computers
    • Laser printers
    • Desktop computers
    Technology
    • Project management software
    • Document management software
    • Data base user interface and query software
    • Compliance software
    • Analytical or scientific software
    Tags
    • InDemand occupations are considered a priority by the state of Ohio.
    • Green occupations are jobs that contribute to energy conservation, development of alternative energy, reducing pollution, or recycling.