According to people in this career, the main tasks are...
| Task | Importance |
|---|---|
| Provide responses to regulatory agencies regarding product information or issues. | 95% |
| Direct the preparation and submission of regulatory agency applications, reports, or correspondence. | 92% |
| Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. | 92% |
| Develop regulatory strategies and implementation plans for the preparation and submission of new products. | 91% |
| Manage activities such as audits, regulatory agency inspections, or product recalls. | 90% |
| Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. | 90% |
| Maintain current knowledge of relevant regulations, including proposed and final rules. | 89% |
| Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met. | 88% |
| Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. | 87% |
| Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. | 86% |
| Direct documentation efforts to ensure compliance with domestic and international regulations and standards. | 85% |
| Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes. | 85% |
| Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary. | 84% |
| Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. | 80% |
| Train staff in regulatory policies or procedures. | 80% |
| Develop and maintain standard operating procedures or local working practices. | 78% |
| Participate in the development or implementation of clinical trial protocols. | 75% |
| Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations. | 74% |
| Contribute to the development or implementation of business unit strategic and operating plans. | 72% |
| Establish procedures or systems for publishing document submissions in hardcopy or electronic formats. | 70% |
| Coordinate internal discoveries and depositions with legal department staff. | 70% |
| Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations. | 70% |
| Establish regulatory priorities or budgets and allocate resources and workloads. | 68% |
| Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions. | 64% |
| Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives. | 62% |
| Monitor regulatory affairs trends related to environmental issues. | 56% |
| Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation. | 52% |
