Career Details

Core

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