Regulatory Affairs Managers

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

Median Annual Wage: $105,060

Education: Bachelor's degree (64%); Master's degree (21%); Post-baccalaureate certificate (6%)

Projected Growth: Slower than average (3% to 7%)

Related Job Titles: Clinical Trials Systems Administrator; Global Regulatory Affairs Manager; Regulatory Affairs Director; Regulatory Affairs Manager; Regulatory Affairs Portfolio Leader; Regulatory Consultant; Regulatory Leader; Regulatory Product Manager

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Source: O*NET OnLine information for Regulatory Affairs Managers.

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  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
  • Participate in the development or implementation of clinical trial protocols.
  • Develop and maintain standard operating procedures or local working practices.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Train staff in regulatory policies or procedures.
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  • Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
  • Contribute to the development or implementation of business unit strategic and operating plans.

Source: O*NET OnLine information for Regulatory Affairs Managers.

  • Speaking - Talking to others to convey information effectively.
  • Writing - Communicating effectively in writing as appropriate for the needs of the audience.
  • Judgment and Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one.
  • 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.
  • Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
  • Time Management - Managing one's own time and the time of others.
  • Coordination - Adjusting actions in relation to others' actions.
  • Monitoring - Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
  • Systems Analysis - Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.

Source: O*NET OnLine information for Regulatory Affairs Managers.

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