What does a Regulatory Affair Manager do?
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
- 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.
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
- 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 either in hardcopy or electronic formats.
- Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to 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.
- Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
- Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives.
- Monitor regulatory affairs trends that are related to environmental issues.