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