11-9199.01 · Task explorer
Regulatory Affairs Managers: reported tasks and exploration worksheet
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
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Read the task inventory
This source lists 27 tasks, including 26 marked Core and 1 marked Supplemental. Labels and dates are retained below. Employers can combine or divide these responsibilities differently; explore the task itself before assuming it belongs in every version of the role.
Task source dates: 08/2024.
27 tasks shown
Core · Task 18026 · 08/2024 · Occupational Expert
Develop regulatory strategies and implementation plans for the preparation and submission of new products.
Core · Task 18037 · 08/2024 · Occupational Expert
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
Core · Task 18022 · 08/2024 · Occupational Expert
Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
Core · Task 18029 · 08/2024 · Occupational Expert
Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
Core · Task 18035 · 08/2024 · Occupational Expert
Provide responses to regulatory agencies regarding product information or issues.
Core · Task 18036 · 08/2024 · Occupational Expert
Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
Core · Task 18024 · 08/2024 · Occupational Expert
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
Core · Task 18031 · 08/2024 · Occupational Expert
Manage activities such as audits, regulatory agency inspections, or product recalls.
Core · Task 18025 · 08/2024 · Occupational Expert
Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
Core · Task 18030 · 08/2024 · Occupational Expert
Maintain current knowledge of relevant regulations, including proposed and final rules.
Core · Task 18023 · 08/2024 · Occupational Expert
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Core · Task 21087 · 08/2024 · Occupational Expert
Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
Core · Task 18038 · 08/2024 · Occupational Expert
Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
Core · Task 18034 · 08/2024 · Occupational Expert
Participate in the development or implementation of clinical trial protocols.
Core · Task 18028 · 08/2024 · Occupational Expert
Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
Core · Task 18043 · 08/2024 · Occupational Expert
Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
Core · Task 18027 · 08/2024 · Occupational Expert
Establish regulatory priorities or budgets and allocate resources and workloads.
Core · Task 18039 · 08/2024 · Occupational Expert
Train staff in regulatory policies or procedures.
Core · Task 18042 · 08/2024 · Occupational Expert
Develop and maintain standard operating procedures or local working practices.
Core · Task 18040 · 08/2024 · Occupational Expert
Contribute to the development or implementation of business unit strategic and operating plans.
Core · Task 19531 · 08/2024 · Occupational Expert
Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
Core · Task 18041 · 08/2024 · Occupational Expert
Coordinate internal discoveries and depositions with legal department staff.
Core · Task 18032 · 08/2024 · Occupational Expert
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
Core · Task 19529 · 08/2024 · Occupational Expert
Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
Core · Task 19532 · 08/2024 · Occupational Expert
Monitor regulatory affairs trends related to environmental issues.
Core · Task 19530 · 08/2024 · Occupational Expert
Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
Supplemental · Task 18044 · 08/2024 · Occupational Expert
Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
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- For each, write an example you can discuss or a question that would change your understanding of the role.
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Source and practice material
Occupational context uses the O*NET® 31.0 Database from the U.S. Department of Labor, Employment and Training Administration, under CC BY 4.0. View the occupation.
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