What do Regulatory Affairs Managers 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.
  • 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.
  • Coordinate internal discoveries and depositions with legal department staff.
  • 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.

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Necessary Skills

  • Reading Comprehension
  • Critical Thinking
  • Speaking
  • Writing
  • Active Listening
  • Coordination