Skip navigation

Regulatory Affairs Managers - 11-9199.01

O*NET-SOC Description

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Sample of Reported Job Titles

No information available.

SOC Occupation Groups

11-0000 Management Occupations
11-9000 Other Management Occupations
11-9190 Miscellaneous Managers
11-9199.00 Managers, All Other
11-9199.01 Regulatory Affairs Managers

Related Occupations

Tasks

  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • 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.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.
  • Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • 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.
  • 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.
  • Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
  • Participate in the development or implementation of clinical trial protocols.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • 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.

Detailed Work Activities

  • Advise others on legal or regulatory compliance matters.
  • Communicate organizational policies and procedures.
  • Conduct employee training programs.
  • Confer with organizational members to accomplish work activities.
  • Coordinate operational activities with external stakeholders.
  • Coordinate with external parties to exchange information.
  • Develop operating strategies, plans, or procedures.
  • Develop organizational goals or objectives.
  • Develop organizational methods or procedures.
  • Develop organizational policies or programs.
  • Establish interpersonal business relationships to facilitate work activities.
  • Evaluate environmental impact of operational or development activities.
  • Evaluate potential of products, technologies, or resources.
  • Examine marketing materials to ensure compliance with policies or regulations.
  • Implement organizational process or policy changes.
  • Maintain knowledge of current developments in area of expertise.
  • Maintain regulatory or compliance documentation.
  • Manage control system activities in organizations.
  • Monitor external affairs or events affecting business operations.
  • Monitor organizational compliance with regulations.
  • Monitor organizational procedures to ensure proper functioning.
  • Prepare operational budgets.
  • Prepare reports related to compliance matters.
  • Prepare staff schedules or work assignments.
  • Represent the organization in external relations.
  • Review documents or materials for compliance with policies or regulations.

Military Crosswalk Titles

No information available.

Apprenticeship Crosswalk Titles

No information available.

DOT Crosswalk Titles

No information available.