Regulatory Affairs Managers

• 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.
• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
• Manage activities such as audits, regulatory agency inspections, or product recalls.
• 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.
• Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• 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.
• Coordination - Adjusting actions in relation to others' actions.
• Time Management - Managing one's own time and the time of others.
• 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.