[Core] [20% incumbents] Coordinate efforts associated with the preparation of regulatory documents or submissions.
  DWAs: Coordinate regulatory documentation activities.

[Core] [20% incumbents] Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  DWAs: Obtain documentation to authorize activities.

[Core] [20% incumbents] Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  DWAs: Coordinate regulatory documentation activities.

[Core] [20% incumbents] Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  DWAs: Prepare regulatory or compliance documentation. | Coordinate regulatory documentation activities.

[Core] [20% incumbents] Prepare or maintain technical files as necessary to obtain and sustain product approval.
  DWAs: Prepare regulatory or compliance documentation.

[Core] [20% incumbents] Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  DWAs: Explain regulations, policies, or procedures.

[Core] [20% incumbents] Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  DWAs: Evaluate applicable laws and regulations to determine impact on organizational activities.

[Core] [20% incumbents] Coordinate recall or market withdrawal activities as necessary.
  DWAs: Oversee business processes.

[Core] [20% incumbents] Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  DWAs: Advise others on legal or regulatory compliance matters.

[Core] [20% incumbents] Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  DWAs: Examine product information to ensure compliance with regulations.

[Core] [20% incumbents] Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  DWAs: Examine product information to ensure compliance with regulations.

[Core] [20% incumbents] Identify relevant guidance documents, international standards, or consensus standards.
  DWAs: Compile technical information or documentation. | Review documents or materials for compliance with policies or regulations. | Evaluate applicable laws and regulations to determine impact on organizational activities.

[Core] [20% incumbents] Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  DWAs: Coordinate regulatory documentation activities.

[Core] [20% incumbents] Review clinical protocols to ensure collection of data needed for regulatory submissions.
  DWAs: Evaluate applicable laws and regulations to determine impact on organizational activities.

[Core] [20% incumbents] Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
  DWAs: Communicate with government agencies.

[Core] [20% incumbents] Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  DWAs: Update knowledge of legal or regulatory environments.

[Core] [20% incumbents] Recommend changes to company procedures in response to changes in regulations or standards.
  DWAs: Advise others on legal or regulatory compliance matters.

[Core] [20% incumbents] Participate in internal or external audits.
  DWAs: Examine financial records or processes.

[Core] [20% incumbents] Compile and maintain regulatory documentation databases or systems.
  DWAs: Maintain data in information systems or databases.

[Core] [20% incumbents] Write or update standard operating procedures, work instructions, or policies.
  DWAs: Establish organizational guidelines or policies. | Prepare financial documents.

[Core] [20% incumbents] Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  DWAs: Update knowledge of legal or regulatory environments.

[Core] [20% incumbents] Develop or track quality metrics.
  DWAs: Monitor business indicators.

[Core] [20% incumbents] Develop or conduct employee regulatory training.
  DWAs: Train personnel in organizational or compliance procedures.

[Core] [20% incumbents] Recommend adjudication of product complaints.
  DWAs: Investigate system, equipment, or product failures. | Analyze data to identify or resolve operational problems. | Recommend changes or corrective procedures.

[Supplemental] [20% incumbents] Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
  DWAs: Analyze environmental regulations to ensure organizational compliance.

[Supplemental] [20% incumbents] Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  DWAs: Oversee business processes.

[Supplemental] [20% incumbents] Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  DWAs: Correspond with customers to answer questions or resolve complaints.

[Supplemental] [20% incumbents] Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
  DWAs: Update knowledge of legal or regulatory environments.

[Supplemental] [20% incumbents] Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
  DWAs: Analyze environmental regulations to ensure organizational compliance.

[Supplemental] [20% incumbents] Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
  DWAs: Analyze environmental regulations to ensure organizational compliance.

[EMERGING:New] Develop regulatory strategies for products.

--- SKILLS ---
  Active Listening (imp:4.00 lvl:4.00) — Giving full attention to what other people are saying, taking time to understand
  Writing (imp:4.00 lvl:4.12) — Communicating effectively in writing as appropriate for the needs of the audienc
  Speaking (imp:4.00 lvl:4.12) — Talking to others to convey information effectively.
  Reading Comprehension (imp:3.88 lvl:4.75) — Understanding written sentences and paragraphs in work-related documents.
  Critical Thinking (imp:3.88 lvl:4.25) — Using logic and reasoning to identify the strengths and weaknesses of alternativ
  Active Learning (imp:3.25 lvl:3.88) — Understanding the implications of new information for both current and future pr
  Monitoring (imp:3.25 lvl:3.75) — Monitoring/Assessing performance of yourself, other individuals, or organization
  Learning Strategies (imp:3.00 lvl:3.00) — Selecting and using training/instructional methods and procedures appropriate fo
  Mathematics (imp:2.50 lvl:2.88) — Using mathematics to solve problems.
  Science (imp:1.88 lvl:1.12) — Using scientific rules and methods to solve problems.

--- KNOWLEDGE ---
  English Language (imp:4.50 lvl:4.55) — Knowledge of the structure and content of the English language including the mea
  Law and Government (imp:4.10 lvl:4.55) — Knowledge of laws, legal codes, court procedures, precedents, government regulat
  Biology (imp:3.45 lvl:3.85) — Knowledge of plant and animal organisms, their tissues, cells, functions, interd
  Computers and Electronics (imp:3.40 lvl:3.60) — Knowledge of circuit boards, processors, chips, electronic equipment, and comput
  Administration and Management (imp:3.37 lvl:4.05) — Knowledge of business and management principles involved in strategic planning, 
  Administrative (imp:3.17 lvl:4.11) — Knowledge of administrative and office procedures and systems such as word proce
  Chemistry (imp:2.79 lvl:3.35) — Knowledge of the chemical composition, structure, and properties of substances a
  Medicine and Dentistry (imp:2.79 lvl:2.90) — Knowledge of the information and techniques needed to diagnose and treat human i
  Communications and Media (imp:2.65 lvl:2.80) — Knowledge of media production, communication, and dissemination techniques and m
  Production and Processing (imp:2.60 lvl:3.10) — Knowledge of raw materials, production processes, quality control, costs, and ot
  Education and Training (imp:2.60 lvl:3.30) — Knowledge of principles and methods for curriculum and training design, teaching
  Engineering and Technology (imp:2.58 lvl:2.55) — Knowledge of the practical application of engineering science and technology. Th
  Mathematics (imp:2.55 lvl:3.45) — Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their appl
  Customer and Personal Service (imp:2.45 lvl:2.80) — Knowledge of principles and processes for providing customer and personal servic
  Telecommunications (imp:2.05 lvl:1.25) — Knowledge of transmission, broadcasting, switching, control, and operation of te
  Design (imp:2.00 lvl:1.45) — Knowledge of design techniques, tools, and principles involved in production of 
  Foreign Language (imp:2.00 lvl:1.75) — Knowledge of the structure and content of a foreign (non-English) language inclu
  Public Safety and Security (imp:2.00 lvl:1.75) — Knowledge of relevant equipment, policies, procedures, and strategies to promote
  Sales and Marketing (imp:1.84 lvl:1.79) — Knowledge of principles and methods for showing, promoting, and selling products
  Personnel and Human Resources (imp:1.84 lvl:2.00) — Knowledge of principles and procedures for personnel recruitment, selection, tra
  Geography (imp:1.75 lvl:1.60) — Knowledge of principles and methods for describing the features of land, sea, an
  Psychology (imp:1.67 lvl:1.47) — Knowledge of human behavior and performance; individual differences in ability, 
  Physics (imp:1.65 lvl:1.25) — Knowledge and prediction of physical principles, laws, their interrelationships,
  Economics and Accounting (imp:1.47 lvl:0.89) — Knowledge of economic and accounting principles and practices, the financial mar
  Mechanical (imp:1.45 lvl:0.85) — Knowledge of machines and tools, including their designs, uses, repair, and main
  Sociology and Anthropology (imp:1.45 lvl:0.80) — Knowledge of group behavior and dynamics, societal trends and influences, human 
  Transportation (imp:1.30 lvl:0.90) — Knowledge of principles and methods for moving people or goods by air, rail, sea
  Food Production (imp:1.25 lvl:0.65) — Knowledge of techniques and equipment for planting, growing, and harvesting food
  Therapy and Counseling (imp:1.20 lvl:0.50) — Knowledge of principles, methods, and procedures for diagnosis, treatment, and r
  History and Archeology (imp:1.15 lvl:0.50) — Knowledge of historical events and their causes, indicators, and effects on civi
  Philosophy and Theology (imp:1.15 lvl:0.40) — Knowledge of different philosophical systems and religions. This includes their 
  Building and Construction (imp:1.10 lvl:0.15) — Knowledge of materials, methods, and the tools involved in the construction or r
  Fine Arts (imp:1.00) — Knowledge of the theory and techniques required to compose, produce, and perform

--- ABILITIES ---
  Written Comprehension (imp:4.25 lvl:4.88) — The ability to read and understand information and ideas presented in writing.
  Written Expression (imp:4.12 lvl:4.12) — The ability to communicate information and ideas in writing so others will under
  Oral Comprehension (imp:4.00 lvl:4.88) — The ability to listen to and understand information and ideas presented through 
  Oral Expression (imp:4.00 lvl:4.62) — The ability to communicate information and ideas in speaking so others will unde
  Problem Sensitivity (imp:3.88 lvl:4.00) — The ability to tell when something is wrong or is likely to go wrong. It does no
  Deductive Reasoning (imp:3.88 lvl:4.12) — The ability to apply general rules to specific problems to produce answers that 
  Inductive Reasoning (imp:3.88 lvl:3.88) — The ability to combine pieces of information to form general rules or conclusion
  Speech Clarity (imp:3.88 lvl:3.88) — The ability to speak clearly so others can understand you.
  Speech Recognition (imp:3.75 lvl:3.88) — The ability to identify and understand the speech of another person.
  Information Ordering (imp:3.62 lvl:3.88) — The ability to arrange things or actions in a certain order or pattern according
  Near Vision (imp:3.62 lvl:4.00) — The ability to see details at close range (within a few feet of the observer).
  Fluency of Ideas (imp:3.12 lvl:3.62) — The ability to come up with a number of ideas about a topic (the number of ideas
  Category Flexibility (imp:3.00 lvl:3.50) — The ability to generate or use different sets of rules for combining or grouping
  Mathematical Reasoning (imp:3.00 lvl:3.00) — The ability to choose the right mathematical methods or formulas to solve a prob
  Originality (imp:2.88 lvl:3.25) — The ability to come up with unusual or clever ideas about a given topic or situa
  Flexibility of Closure (imp:2.88 lvl:3.62) — The ability to identify or detect a known pattern (a figure, object, word, or so
  Perceptual Speed (imp:2.88 lvl:2.88) — The ability to quickly and accurately compare similarities and differences among
  Selective Attention (imp:2.88 lvl:2.75) — The ability to concentrate on a task over a period of time without being distrac
  Far Vision (imp:2.88 lvl:2.88) — The ability to see details at a distance.
  Memorization (imp:2.62 lvl:2.62) — The ability to remember information such as words, numbers, pictures, and proced
  Speed of Closure (imp:2.62 lvl:3.00) — The ability to quickly make sense of, combine, and organize information into mea
  Number Facility (imp:2.50 lvl:2.88) — The ability to add, subtract, multiply, or divide quickly and correctly.
  Visualization (imp:2.38 lvl:2.00) — The ability to imagine how something will look after it is moved around or when 
  Time Sharing (imp:2.25 lvl:2.12) — The ability to shift back and forth between two or more activities or sources of
  Finger Dexterity (imp:2.25 lvl:1.62) — The ability to make precisely coordinated movements of the fingers of one or bot
  Auditory Attention (imp:2.12 lvl:1.88) — The ability to focus on a single source of sound in the presence of other distra
  Visual Color Discrimination (imp:2.00 lvl:2.00) — The ability to match or detect differences between colors, including shades of c
  Hearing Sensitivity (imp:2.00 lvl:1.88) — The ability to detect or tell the differences between sounds that vary in pitch 
  Depth Perception (imp:1.88 lvl:1.00) — The ability to judge which of several objects is closer or farther away from you
  Trunk Strength (imp:1.62 lvl:0.88) — The ability to use your abdominal and lower back muscles to support part of the 
  Wrist-Finger Speed (imp:1.25 lvl:0.38) — The ability to make fast, simple, repeated movements of the fingers, hands, and 
  Spatial Orientation (imp:1.00) — The ability to know your location in relation to the environment or to know wher
  Arm-Hand Steadiness (imp:1.00) — The ability to keep your hand and arm steady while moving your arm or while hold
  Manual Dexterity (imp:1.00) — The ability to quickly move your hand, your hand together with your arm, or your
  Control Precision (imp:1.00) — The ability to quickly and repeatedly adjust the controls of a machine or a vehi
  Multilimb Coordination (imp:1.00) — The ability to coordinate two or more limbs (for example, two arms, two legs, or
  Response Orientation (imp:1.00) — The ability to choose quickly between two or more movements in response to two o
  Rate Control (imp:1.00) — The ability to time your movements or the movement of a piece of equipment in an
  Reaction Time (imp:1.00) — The ability to quickly respond (with the hand, finger, or foot) to a signal (sou
  Speed of Limb Movement (imp:1.00) — The ability to quickly move the arms and legs.
  Static Strength (imp:1.00) — The ability to exert maximum muscle force to lift, push, pull, or carry objects.
  Explosive Strength (imp:1.00) — The ability to use short bursts of muscle force to propel oneself (as in jumping
  Dynamic Strength (imp:1.00) — The ability to exert muscle force repeatedly or continuously over time. This inv
  Stamina (imp:1.00) — The ability to exert yourself physically over long periods of time without getti
  Extent Flexibility (imp:1.00) — The ability to bend, stretch, twist, or reach with your body, arms, and/or legs.
  Dynamic Flexibility (imp:1.00) — The ability to quickly and repeatedly bend, stretch, twist, or reach out with yo
  Gross Body Coordination (imp:1.00) — The ability to coordinate the movement of your arms, legs, and torso together wh
  Gross Body Equilibrium (imp:1.00) — The ability to keep or regain your body balance or stay upright when in an unsta
  Night Vision (imp:1.00) — The ability to see under low-light conditions.
  Peripheral Vision (imp:1.00) — The ability to see objects or movement of objects to one's side when the eyes ar
  Glare Sensitivity (imp:1.00) — The ability to see objects in the presence of a glare or bright lighting.
  Sound Localization (imp:1.00) — The ability to tell the direction from which a sound originated.

--- WORK ACTIVITIES ---
  Evaluating Information to Determine Compliance with Standards (imp:4.63 lvl:5.15) — Using relevant information and individual judgment to determine whether events o
  Getting Information (imp:4.60 lvl:5.50) — Observing, receiving, and otherwise obtaining information from all relevant sour
  Communicating with Supervisors, Peers, or Subordinates (imp:4.45 lvl:5.25) — Providing information to supervisors, co-workers, and subordinates by telephone,
  Communicating with People Outside the Organization (imp:4.30 lvl:5.20) — Communicating with people outside the organization, representing the organizatio
  Working with Computers (imp:4.25 lvl:3.37) — Using computers and computer systems (including hardware and software) to progra
  Making Decisions and Solving Problems (imp:4.22 lvl:4.89) — Analyzing information and evaluating results to choose the best solution and sol
  Interpreting the Meaning of Information for Others (imp:4.21 lvl:4.70) — Translating or explaining what information means and how it can be used.
  Updating and Using Relevant Knowledge (imp:4.20 lvl:5.05) — Keeping up-to-date technically and applying new knowledge to your job.
  Establishing and Maintaining Interpersonal Relationships (imp:4.15 lvl:5.20) — Developing constructive and cooperative working relationships with others, and m
  Analyzing Data or Information (imp:4.05 lvl:4.95) — Identifying the underlying principles, reasons, or facts of information by break
  Organizing, Planning, and Prioritizing Work (imp:4.05 lvl:5.30) — Developing specific goals and plans to prioritize, organize, and accomplish your
  Developing Objectives and Strategies (imp:3.85 lvl:4.35) — Establishing long-range objectives and specifying the strategies and actions to 
  Resolving Conflicts and Negotiating with Others (imp:3.79 lvl:4.80) — Handling complaints, settling disputes, and resolving grievances and conflicts, 
  Providing Consultation and Advice to Others (imp:3.75 lvl:4.60) — Providing guidance and expert advice to management or other groups on technical,
  Documenting/Recording Information (imp:3.74 lvl:4.30) — Entering, transcribing, recording, storing, or maintaining information in writte
  Coordinating the Work and Activities of Others (imp:3.70 lvl:4.90) — Getting members of a group to work together to accomplish tasks.
  Scheduling Work and Activities (imp:3.55 lvl:4.50) — Scheduling events, programs, and activities, as well as the work of others.
  Developing and Building Teams (imp:3.55 lvl:4.30) — Encouraging and building mutual trust, respect, and cooperation among team membe
  Processing Information (imp:3.47 lvl:4.55) — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying
  Identifying Objects, Actions, and Events (imp:3.45 lvl:4.55) — Identifying information by categorizing, estimating, recognizing differences or 
  Training and Teaching Others (imp:3.25 lvl:4.15) — Identifying the educational needs of others, developing formal educational or tr
  Performing Administrative Activities (imp:3.25 lvl:3.95) — Performing day-to-day administrative tasks such as maintaining information files
  Judging the Qualities of Objects, Services, or People (imp:3.15 lvl:3.90) — Assessing the value, importance, or quality of things or people.
  Coaching and Developing Others (imp:3.05 lvl:4.05) — Identifying the developmental needs of others and coaching, mentoring, or otherw
  Guiding, Directing, and Motivating Subordinates (imp:2.95 lvl:3.40) — Providing guidance and direction to subordinates, including setting performance 
  Thinking Creatively (imp:2.90 lvl:3.10) — Developing, designing, or creating new applications, ideas, relationships, syste
  Selling or Influencing Others (imp:2.90 lvl:3.20) — Convincing others to buy merchandise/goods or to otherwise change their minds or
  Estimating the Quantifiable Characteristics of Products, Events, or Information (imp:2.80 lvl:3.20) — Estimating sizes, distances, and quantities; or determining time, costs, resourc
  Monitoring Processes, Materials, or Surroundings (imp:2.68 lvl:3.42) — Monitoring and reviewing information from materials, events, or the environment,
  Staffing Organizational Units (imp:2.45 lvl:3.45) — Recruiting, interviewing, selecting, hiring, and promoting employees in an organ
  Monitoring and Controlling Resources (imp:2.45 lvl:2.40) — Monitoring and controlling resources and overseeing the spending of money.
  Inspecting Equipment, Structures, or Materials (imp:2.15 lvl:2.05) — Inspecting equipment, structures, or materials to identify the cause of errors o
  Assisting and Caring for Others (imp:1.85 lvl:1.65) — Providing personal assistance, medical attention, emotional support, or other pe
  Performing for or Working Directly with the Public (imp:1.65 lvl:1.15) — Performing for people or dealing directly with the public. This includes serving
  Drafting, Laying Out, and Specifying Technical Devices, Parts, and Equipment (imp:1.50 lvl:0.80) — Providing documentation, detailed instructions, drawings, or specifications to t
  Performing General Physical Activities (imp:1.40 lvl:0.65) — Performing general physical activities includes doing activities that require co
  Controlling Machines and Processes (imp:1.35 lvl:0.65) — Using either control mechanisms or direct physical activity to operate machines 
  Handling and Moving Objects (imp:1.25 lvl:0.50) — Using hands and arms in handling, installing, positioning, and moving materials,
  Repairing and Maintaining Electronic Equipment (imp:1.25 lvl:0.45) — Servicing, repairing, calibrating, regulating, fine-tuning, or testing machines,
  Repairing and Maintaining Mechanical Equipment (imp:1.15 lvl:0.40) — Servicing, repairing, adjusting, and testing machines, devices, moving parts, an
  Operating Vehicles, Mechanized Devices, or Equipment (imp:1.11 lvl:0.22) — Running, maneuvering, navigating, or driving vehicles or mechanized equipment, s

--- WORK STYLES ---
  Dependability (imp:5.00) — A tendency to be reliable, responsible, and consistent in meeting work-related o
  Attention to Detail (imp:4.00) — A tendency to be detail-oriented, organized, and thorough in completing work.
  Attention to Detail (imp:3.00) — A tendency to be detail-oriented, organized, and thorough in completing work.
  Integrity (imp:3.00) — A tendency to be honest and ethical at work.
  Dependability (imp:2.65) — A tendency to be reliable, responsible, and consistent in meeting work-related o
  Cautiousness (imp:2.62) — A tendency to be careful, deliberate, and risk-avoidant when making work-related
  Integrity (imp:2.55) — A tendency to be honest and ethical at work.
  Intellectual Curiosity (imp:2.20) — A tendency to seek out and acquire new work-related knowledge and obtain a deep 
  Cautiousness (imp:2.00) — A tendency to be careful, deliberate, and risk-avoidant when making work-related
  Achievement Orientation (imp:1.80) — A tendency to establish and maintain personally challenging work-related goals, 
  Cooperation (imp:1.67) — A tendency to be pleasant, helpful, and willing to assist others at work.
  Perseverance (imp:1.61) — A tendency to exhibit determination and resolve to perform or complete tasks in 
  Initiative (imp:1.44) — A tendency to be proactive and take on extra responsibilities and tasks that may
  Self-Confidence (imp:1.44) — A tendency to believe in one's work-related capabilities and ability to control 
  Stress Tolerance (imp:1.43) — A tendency to cope and function effectively in stressful situations at work.
  Self-Control (imp:1.37) — A tendency to remain calm and composed and to manage emotions effectively in res
  Adaptability (imp:1.22) — A tendency to be open to and comfortable with change, new experiences, or ideas 
  Intellectual Curiosity (imp:1.00) — A tendency to seek out and acquire new work-related knowledge and obtain a deep 
  Sincerity (imp:0.98) — A tendency to be genuine and sincere in interactions with others at work, withou
  Leadership Orientation (imp:0.88) — A tendency to lead, take charge, offer opinions, and provide direction at work.
  Social Orientation (imp:0.88) — A tendency to seek out, enjoy, and be energized by social interaction at work.
  Humility (imp:0.61) — A tendency to be modest and humble when interacting with others at work.
  Tolerance for Ambiguity (imp:0.40) — A tendency to be comfortable with ambiguity and uncertainty at work.
  Empathy (imp:0.34) — A tendency to show concern for others and be sensitive to others' needs and feel
  Optimism (imp:0.28) — A tendency to exhibit a positive attitude and positive emotions at work, even un
  Innovation (imp:0.24) — A tendency to be inventive, to be imaginative, and to adopt new perspectives on 
  Innovation () — A tendency to be inventive, to be imaginative, and to adopt new perspectives on 
  Achievement Orientation () — A tendency to establish and maintain personally challenging work-related goals, 
  Tolerance for Ambiguity () — A tendency to be comfortable with ambiguity and uncertainty at work.
  Initiative () — A tendency to be proactive and take on extra responsibilities and tasks that may
  Adaptability () — A tendency to be open to and comfortable with change, new experiences, or ideas 
  Self-Confidence () — A tendency to believe in one's work-related capabilities and ability to control 
  Perseverance () — A tendency to exhibit determination and resolve to perform or complete tasks in 
  Leadership Orientation () — A tendency to lead, take charge, offer opinions, and provide direction at work.
  Humility () — A tendency to be modest and humble when interacting with others at work.
  Sincerity () — A tendency to be genuine and sincere in interactions with others at work, withou
  Empathy () — A tendency to show concern for others and be sensitive to others' needs and feel
  Cooperation () — A tendency to be pleasant, helpful, and willing to assist others at work.
  Optimism () — A tendency to exhibit a positive attitude and positive emotions at work, even un
  Social Orientation () — A tendency to seek out, enjoy, and be energized by social interaction at work.
  Stress Tolerance () — A tendency to cope and function effectively in stressful situations at work.
  Self-Control () — A tendency to remain calm and composed and to manage emotions effectively in res

--- TRANSFERABLE SKILLS ---
  Judgment and Decision Making (imp:3.88 lvl:4.12) — Considering the relative costs and benefits of potential actions to choose the m
  Complex Problem Solving (imp:3.75 lvl:3.88) — Identifying complex problems and reviewing related information to develop and ev
  Systems Analysis (imp:3.75 lvl:4.00) — Determining how a system should work and how changes in conditions, operations, 
  Social Perceptiveness (imp:3.38 lvl:3.25) — Being aware of others' reactions and understanding why they react as they do.
  Time Management (imp:3.38 lvl:3.38) — Managing one's own time and the time of others.
  Systems Evaluation (imp:3.25 lvl:3.88) — Identifying measures or indicators of system performance and the actions needed 
  Coordination (imp:3.12 lvl:3.88) — Adjusting actions in relation to others' actions.
  Negotiation (imp:3.12 lvl:3.25) — Bringing others together and trying to reconcile differences.
  Persuasion (imp:3.00 lvl:3.75) — Persuading others to change their minds or behavior.
  Instructing (imp:3.00 lvl:3.00) — Teaching others how to do something.
  Service Orientation (imp:3.00 lvl:3.00) — Actively looking for ways to help people.
  Management of Personnel Resources (imp:2.88 lvl:3.00) — Motivating, developing, and directing people as they work, identifying the best 
  Operations Analysis (imp:2.62 lvl:2.62) — Analyzing needs and product requirements to create a design.
  Quality Control Analysis (imp:2.12 lvl:2.00) — Conducting tests and inspections of products, services, or processes to evaluate
  Management of Financial Resources (imp:2.12 lvl:1.88) — Determining how money will be spent to get the work done, and accounting for the
  Operations Monitoring (imp:2.00 lvl:1.75) — Watching gauges, dials, or other indicators to make sure a machine is working pr
  Management of Material Resources (imp:2.00 lvl:1.38) — Obtaining and seeing to the appropriate use of equipment, facilities, and materi
  Technology Design (imp:1.88 lvl:1.00) — Generating or adapting equipment and technology to serve user needs.
  Programming (imp:1.88 lvl:1.38) — Writing computer programs for various purposes.
  Equipment Selection (imp:1.00) — Determining the kind of tools and equipment needed to do a job.
  Installation (imp:1.00) — Installing equipment, machines, wiring, or programs to meet specifications.
  Operation and Control (imp:1.00) — Controlling operations of equipment or systems.
  Equipment Maintenance (imp:1.00) — Performing routine maintenance on equipment and determining when and what kind o
  Troubleshooting (imp:1.00) — Determining causes of operating errors and deciding what to do about it.
  Repairing (imp:1.00) — Repairing machines or systems using the needed tools.

--- NATIONAL WAGES ---
  total_employment : 417,070
  annual_median    : $80,730
  annual_pct10     : $48,220
  annual_pct25     : $61,280
  annual_pct75     : $109,010
  annual_pct90     : $133,720
  annual_mean      : $88,400
  hourly_median    : $38.81

--- GEOGRAPHIC DISPERSION ---
  highest_state    : District of Columbia ($111,030)
  lowest_state     : Puerto Rico ($48,950)
  dispersion_ratio : 2.268x

--- TOP STATES BY WAGE (54 total) ---
  Federal, State, and Local Government, excluding State and Local Government Schools and Hospitals and the U.S. Postal Service (OEWS Designation) emp:  142,880  median: $  81,330
  Finance and Insurance                    emp:   46,460  median: $  82,310
  Professional, Scientific, and Technical Services emp:   41,520  median: $  91,960
  Health Care and Social Assistance        emp:   36,120  median: $  72,580
  Management of Companies and Enterprises  emp:   23,550  median: $  88,660
  Administrative and Support and Waste Management and Remediation Services emp:   20,920  median: $  64,320
  Manufacturing                            emp:   19,770  median: $  89,290
  Educational Services                     emp:   16,330  median: $  75,130
  Transportation and Warehousing           emp:   13,470  median: $  66,120
  Information                              emp:    7,510  median: $  94,990

--- TOP INDUSTRIES BY EMPLOYMENT (19 total) ---
  Federal, State, and Local Government, excluding State and Local Government Schools and Hospitals and the U.S. Postal Service (OEWS Designation) emp:  142,880  median: $  81,330
  Finance and Insurance                    emp:   46,460  median: $  82,310
  Professional, Scientific, and Technical Services emp:   41,520  median: $  91,960
  Health Care and Social Assistance        emp:   36,120  median: $  72,580
  Management of Companies and Enterprises  emp:   23,550  median: $  88,660
  Administrative and Support and Waste Management and Remediation Services emp:   20,920  median: $  64,320
  Manufacturing                            emp:   19,770  median: $  89,290
  Educational Services                     emp:   16,330  median: $  75,130
  Transportation and Warehousing           emp:   13,470  median: $  66,120
  Information                              emp:    7,510  median: $  94,990

exact_match_status : no_exact_match
matched_title      : N/A
match_score        : 0.0000
wikidata_qid       : N/A
word_count         : 0
wikipedia_url      : N/A
license            : CC BY-SA 4.0
fetched_at         : 2026-06-02T20:10:47.445431Z

--- SEMANTIC NEIGHBORS (5) ---

  Title: Ayola (similarity: 0.1143)
  URL: https://en.wikipedia.org/wiki/Ayola
  QID: Q123644007
  Extract: Abdullah Adeoye Abubakre better known as Ayola is a Canadian based Nigerian folk singer, songwriter and performer, known for his single Sare Toban which gained recognition on TikTok in December 2022.

  Title: Neuroscience (similarity: 0.2381)
  URL: https://en.wikipedia.org/wiki/Neuroscience
  QID: Q207011
  Extract: Neuroscience is the scientific study of the nervous system, its functions, and its disorders. It is a multidisciplinary science that combines physiology, anatomy, molecular biology, developmental biology, cytology, psychology, physics, computer science, chemistry, medicine, statistics, and mathemati

  Title: Legislative assistant (similarity: 0.4706)
  URL: https://en.wikipedia.org/wiki/Legislative_assistant
  QID: Q1450482
  Extract: A legislative assistant (LA), government relations assistant, legislative coordinator, legislative director (LD), or legislative intern, is a person who works for a legislator as a legislative staffer or for an advocacy group in a politically partisan/semi-partisan or bipartisan capacity, in a non-p

  Title: John Graham (policy analyst) (similarity: 0.3103)
  URL: https://en.wikipedia.org/wiki/John_Graham_(policy_analyst)
  QID: Q6235961
  Extract: John D. Graham is a former senior official in the George W. Bush administration and the former dean of the Indiana University O'Neill School of Public and Environmental Affairs. Graham stepped down from the deanship to return to the O'Neill School faculty in the 2019 academic year.

  Title: Royal College of Physicians and Surgeons of Canada (similarity: 0.2750)
  URL: https://en.wikipedia.org/wiki/Royal_College_of_Physicians_and_Surgeons_of_Canada
  QID: Q2983889
  Extract: The Royal College of Physicians and Surgeons of Canada is a regulatory college which acts as a national, nonprofit organization established in 1929 by a special Act of Parliament to oversee the medical education of specialists in Canada.

model_pass1          : claude-sonnet-4-20250514
model_pass2          : claude-haiku-4-5-20251001
inference_confidence : high
confidence_notes     : High confidence due to detailed O*NET data including specific tasks, work activities, and comprehensive skill/knowledge profiles. BLS wage data provides solid market intelligence foundation.
inferred_at          : 2026-06-03T13:10:13.865280+00:00
tokens_input         : 4,599
tokens_output        : 4,264
cost_usd             : $0.046858
wikipedia_used       : False
wikipedia_title      : None
wikipedia_note       : No exact Wikipedia match found. The closest semantic match was 'Legislative assistant' with 0.471 similarity, which relates to government relations but focuses on legislative rather than regulatory affairs work.

--- PROSE FIELDS ---

ROLE SUMMARY:
Regulatory Affairs Specialists coordinate and document internal regulatory processes, ensuring organizational compliance with government regulations and standards. They prepare materials for regulatory submissions, interpret rule changes, and serve as the primary liaison between organizations and regulatory agencies. These professionals play a critical role in industries where regulatory compliance is essential for business operations, particularly in highly regulated sectors like pharmaceuticals, finance, and government.

DAY IN THE LIFE:
A typical day involves reviewing and preparing regulatory documentation for submission to government agencies, coordinating with cross-functional teams to gather required information, and ensuring all materials meet compliance standards. They spend significant time interpreting new regulations and communicating policy changes throughout their organization through updated procedures and training materials. Much of their work involves detailed analysis of regulatory requirements, preparing technical files to maintain product approvals, and responding to regulatory agency inquiries or requests for additional information. They also monitor adverse events or compliance issues, filing required reports according to agency guidelines, and may coordinate recall or market withdrawal activities when necessary.

WHO THRIVES:
Individuals who excel in this role possess exceptional attention to detail and strong analytical thinking abilities, as they must navigate complex regulatory frameworks and ensure precise compliance. They demonstrate high dependability and integrity, given the critical nature of regulatory submissions and the potential consequences of errors. Strong written and oral communication skills are essential for preparing clear documentation and explaining complex regulations to various stakeholders. Those who thrive tend to be methodical thinkers who can synthesize large amounts of technical and legal information, work well under pressure with strict deadlines, and maintain composure when dealing with regulatory agencies and internal compliance challenges.

CAREER ENTRY:
Most Regulatory Affairs Specialists enter the field with a bachelor's degree, with 80% of professionals holding this level of education according to the employment distribution data. Common degree fields include life sciences, business, law, or related technical disciplines, particularly in industries like pharmaceuticals where biology and chemistry knowledge is valued. Entry-level positions often require some understanding of regulatory frameworks, which can be gained through internships, entry-level compliance roles, or specialized regulatory affairs training programs. Many professionals develop expertise in specific regulatory areas through on-the-job experience and continuing education in regulatory requirements.

CAREER TRAJECTORY:
Career advancement typically leads to senior specialist positions, regulatory affairs management roles, or specialized consulting positions within specific regulatory domains. The natural progression includes Regulatory Affairs Managers (11-9199.01) and Compliance Managers (11-9199.02), as evidenced by the related occupations data. Many professionals develop deep expertise in particular industries or regulatory areas, becoming subject matter experts who command higher compensation and greater responsibility. Senior professionals may transition to director-level positions overseeing entire regulatory departments, move into consulting roles serving multiple clients, or specialize in emerging regulatory areas as industries evolve.

MARKET INTELLIGENCE:
The field employs 417,070 professionals with a median annual salary of $80,730 according to BLS OEWS May 2025 data, with earnings ranging from $48,220 to $133,720 for the 10th to 90th percentiles. Geographic variation is significant, with the highest wages in the District of Columbia at $111,030 and lowest in Puerto Rico at $48,950, representing a 2.27x ratio difference. The largest employment sectors are government (142,880 employed), finance and insurance (46,460), and professional services (41,520), reflecting the critical need for regulatory expertise across heavily regulated industries. Demand remains strong due to increasing regulatory complexity and the need for specialized compliance expertise across multiple sectors including healthcare, finance, and emerging technology industries.

AUTOMATION OUTLOOK:
The role shows moderate resistance to automation due to its reliance on complex judgment, interpretation of nuanced regulatory language, and relationship management with regulatory agencies. While routine document preparation and compliance tracking may become more automated, the core activities of evaluating information for compliance standards (importance 4.6, level 5.2) and interpreting regulatory meanings require human expertise that cannot be easily replicated by current automation technologies. The need for professional communication with regulatory agencies and internal stakeholders will likely preserve human involvement in this field.

--- REASONED EDGES ---
  [career_pathway] Regulatory Affairs Managers (11-9199.01) — confidence:high
    reasoning: Natural progression from specialist to management role with shared regulatory expertise and similar work activities.
    data: Related occupation designation
    data: Management progression pattern
    data: Shared regulatory focus
  [skill_overlap] Compliance Officers (13-1041.00) — confidence:high
    reasoning: Both roles focus on evaluating information for compliance with standards and interpreting regulatory requirements.
    data: Primary-Short relationship
    data: Shared compliance evaluation activities
    data: Similar regulatory knowledge requirements
  [career_pathway] Compliance Managers (11-9199.02) — confidence:high
    reasoning: Management track for compliance professionals with overlapping regulatory and policy interpretation skills.
    data: Primary-Short relationship
    data: Shared compliance focus
    data: Management progression
  [task_similarity] Document Management Specialists (15-1299.03) — confidence:medium
    reasoning: Both roles involve extensive document preparation, coordination, and maintaining technical files for compliance purposes.
    data: Primary-Long relationship
    data: Document coordination activities
    data: Technical file maintenance
  [riasec_cluster] Environmental Compliance Inspectors (13-1041.01) — confidence:medium
    reasoning: Both roles share conventional and enterprising RIASEC profiles focused on regulatory compliance and systematic evaluation.
    data: Primary-Short relationship
    data: Shared SOC parent code 13-1041
    data: Similar compliance evaluation focus
  [knowledge_overlap] Quality Control Systems Managers (11-3051.01) — confidence:medium
    reasoning: Shared focus on administration and management knowledge with systematic evaluation of compliance standards.
    data: Primary-Long relationship
    data: Quality systems overlap
    data: Administrative knowledge requirements

--- NORMALIZER SIGNALS ---
  match_keywords   : ['regulatory affairs', 'compliance specialist', 'regulatory specialist', 'regulatory coordinator', 'regulatory analyst', 'regulatory associate', 'regulatory scientist', 'regulatory consultant']
  exclude_keywords : ['inspector', 'investigator', 'auditor', 'manager', 'director']
  title_patterns   : ['*regulatory affairs*', '*regulatory*specialist', '*compliance*specialist', '*RA*specialist', '*regulatory*associate']
  common_variations: ['RA Specialist', 'Regulatory Affairs Analyst', 'Drug Regulatory Affairs Specialist', 'Clinical Regulatory Affairs', 'Product Safety Specialist', 'Regulatory Coordinator', 'Regulatory Associate', 'Compliance Analyst']

total_terms    : 40
top_words      : ['regulatory', 'tendency', 'others', 'compliance', 'equipment', 'activities', 'regulations', 'procedures', 'standards', 'principles', 'materials', 'documentation', 'government', 'includes', 'legislative', 'control', 'objects', 'changes', 'affairs', 'ideas']
source_layers  : onet_tasks | onet_dimensions | dwas | wikipedia | inference

TERM                    COUNT     FREQ  DOMINANT SOURCE      SOURCE BREAKDOWN
──────────────────────────────────────────────────────────────────────────────────────────
regulatory                 60  0.01995  inference            inference:48%  onet_tasks:28%  dwas:18%
tendency                   42  0.01397  onet_dimensions      onet_dimensions:100%
others                     40  0.01330  onet_dimensions      onet_dimensions:95%  dwas:5%
compliance                 27  0.00898  dwas                 dwas:41%  inference:41%  onet_tasks:11%
equipment                  25  0.00831  onet_dimensions      onet_dimensions:92%  onet_tasks:4%  dwas:4%
activities                 20  0.00665  onet_dimensions      onet_dimensions:45%  dwas:40%  inference:10%
regulations                19  0.00632  dwas                 dwas:53%  onet_tasks:21%  inference:16%
procedures                 16  0.00532  onet_dimensions      onet_dimensions:50%  onet_tasks:25%  dwas:19%
standards                  16  0.00532  onet_dimensions      onet_dimensions:50%  onet_tasks:31%  inference:19%
principles                 16  0.00532  onet_dimensions      onet_dimensions:100%
materials                  15  0.00499  onet_dimensions      onet_dimensions:67%  inference:20%  onet_tasks:7%
documentation              13  0.00432  dwas                 dwas:62%  onet_tasks:15%  inference:15%
government                 13  0.00432  inference            inference:38%  wikipedia:31%  onet_dimensions:23%
includes                   13  0.00432  onet_dimensions      onet_dimensions:92%  inference:8%
legislative                13  0.00432  wikipedia            wikipedia:85%  inference:15%
control                    12  0.00399  onet_dimensions      onet_dimensions:100%
objects                    12  0.00399  onet_dimensions      onet_dimensions:100%
changes                    11  0.00366  onet_tasks           onet_tasks:45%  onet_dimensions:27%  inference:18%
affairs                    11  0.00366  inference            inference:55%  wikipedia:36%  onet_tasks:9%
ideas                      11  0.00366  onet_dimensions      onet_dimensions:100%
product                    10  0.00333  onet_tasks           onet_tasks:40%  dwas:30%  onet_dimensions:20%
production                 10  0.00333  onet_dimensions      onet_dimensions:80%  onet_tasks:20%
management                 10  0.00333  onet_dimensions      onet_dimensions:70%  inference:20%  onet_tasks:10%
problems                   10  0.00333  onet_dimensions      onet_dimensions:90%  dwas:10%
techniques                 10  0.00333  onet_dimensions      onet_dimensions:100%
body                       10  0.00333  onet_dimensions      onet_dimensions:100%
organizational             10  0.00333  dwas                 dwas:80%  onet_dimensions:10%  inference:10%
agencies                    9  0.00299  inference            inference:56%  onet_tasks:33%  dwas:11%
technical                   9  0.00299  onet_dimensions      onet_dimensions:33%  inference:33%  onet_tasks:22%
rules                       9  0.00299  onet_dimensions      onet_dimensions:89%  onet_tasks:11%
legal                       9  0.00299  dwas                 dwas:56%  onet_tasks:11%  onet_dimensions:11%
monitoring                  9  0.00299  onet_dimensions      onet_dimensions:89%  wikipedia:11%
human                       9  0.00299  onet_dimensions      onet_dimensions:78%  inference:22%
resources                   9  0.00299  onet_dimensions      onet_dimensions:100%
events                      9  0.00299  onet_dimensions      onet_dimensions:89%  inference:11%
quickly                     9  0.00299  onet_dimensions      onet_dimensions:100%
orientation                 9  0.00299  onet_dimensions      onet_dimensions:100%
performing                  9  0.00299  onet_dimensions      onet_dimensions:89%  wikipedia:11%
submissions                 8  0.00266  onet_tasks           onet_tasks:75%  inference:25%
needed                      8  0.00266  onet_dimensions      onet_dimensions:88%  onet_tasks:12%