BlissPoint Analytics

Occupation AtlasRegulatory Affairs Specialists

O*NET · 13-1041.07

Regulatory Affairs Specialists

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

Also called Drug Regulatory Affairs Specialist · QA Documentation Coordinator · QA Documentation Coordinator (Quality Assurance Documentation Coordinator) · QA Documentation Specialist · QA Documentation Specialist (Quality Assurance Documentation Specialist) · QA Specialist · QA Specialist (Quality Assurance Specialist) · RA Analyst
27 more

RA Analyst (Regulatory Affairs Analyst) · RA Associate · RA Associate (Regulatory Affairs Associate) · RA Consultant · RA Consultant (Regulatory Affairs Consultant) · RA Coordinator · RA Coordinator (Regulatory Affairs Coordinator) · RA Scientist · RA Strategist · RA Strategist (Regulatory Affairs Strategist) · Regulatory Affairs Scientist (RA Scientist) · Regulatory Analyst · Regulatory Compliance Associate · Regulatory Compliance Specialist · Regulatory Consultant · Regulatory Coordinator · Regulatory Reporting Analyst · Regulatory Scientist · Regulatory Services Consultant · Regulatory Specialist · Regulatory Submissions Associate · Research Compliance Specialist · Research QA Analyst · Research QA Analyst (Research Quality Assurance Analyst) · Research QA Specialist · Research QA Specialist (Research Quality Assurance Specialist) · Risk and Compliance Analyst

Job Zone 4 — Considerable Preparation NeededHolland code CEI35 skills on file

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Job Zone

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5

Zone 4: Considerable Preparation Needed

Considerable preparation. Usually a bachelor's degree plus several years of work-related experience, knowledge, or training.

Job Zone is O*NET's rating of how much education, experience and training an occupation typically needs — a property of the work, not of anyone doing it.

Occupational interest profile

CEIConventional · Enterprising · Investigative — the three strongest interests, in order

  • C Conventional6.32
  • E Enterprising4.46
  • I Investigative3.32
  • S Social2.50
  • R Realistic1.40
  • A Artistic1.00

RIASEC (Holland) interests on O*NET's 0–7 scale: what the work draws on, not what any individual prefers. Hover a row for what each dimension means.

Education and experience

The education level respondents say the job requires, and the most common answer for experience and training.

  • Bachelor's Degree80%
  • Post-Baccalaureate Certificate5%
  • Master's Degree10%
  • Post-Doctoral Training5%
Related work experience
Over 2 years, up to and including 4 years (44%)
On-site or in-plant training
Over 3 months, up to and including 6 months (22%)
On-the-job training
Over 3 months, up to and including 6 months (22%)

Typically associated skills

All 35 O*NET skills, most important first. Importance (1–5) says how much a skill matters here; level (0–7) says how much of it the work calls for, with O*NET's example of a nearby level. Neither is a proficiency rating of a person.

  • Reading Comprehensionbasic4.04.9Level 4 looks like: Understand an email from management describing new personnel policies
  • Critical Thinkingbasic4.04.6Level 4 looks like: Evaluate customer complaints and determine appropriate responses
  • Speakingbasic4.04.5Level 4 looks like: Interview applicants to obtain personal and work history
  • Writingbasic4.04.5Level 4 looks like: Write an email to staff outlining new directives
  • Active Listeningbasic4.04.3Level 4 looks like: Answer inquiries regarding credit references
  • Judgment and Decision Making4.04.3Level 4 looks like: Evaluate a loan application for degree of risk
  • Systems Analysis3.94.1Level 4 looks like: Determine how a new piece of equipment will affect production rates
  • Complex Problem Solving3.94.0Level 4 looks like: Redesign a floor layout to take advantage of new manufacturing techniques
  • Active Learningbasic3.84.1Level 4 looks like: Determine the impact of new menu changes on a restaurant's purchasing requirements
  • Systems Evaluation3.84.0Level 4 looks like: Identify the reasons why a client might be unhappy with a product
  • Coordination3.43.8Level 4 looks like: Work with others to put a new roof on a house
  • Monitoringbasic3.33.8Level 4 looks like: Monitor a meeting and revise the agenda to ensure important topics are discussed
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Tasks

25 core · 5 supplemental

What people in this occupation do, as O*NET records it, core tasks first by importance (1–5).

  1. Coordinate, prepare, or review regulatory submissions for domestic or international projects.4.8
  2. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.4.7
  3. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.4.7
  4. Coordinate efforts associated with the preparation of regulatory documents or submissions.4.6
  5. Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.4.6
  6. Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.4.6
  7. Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.4.5
  8. Prepare or maintain technical files as necessary to obtain and sustain product approval.4.4
  9. Coordinate recall or market withdrawal activities as necessary.4.4
  10. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.4.3
  11. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.4.3
  12. Identify relevant guidance documents, international standards, or consensus standards.4.3
Show the other 18
  1. Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.4.3
  2. Develop regulatory strategies for products.4.3
  3. Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.4.2
  4. Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.4.2
  5. Participate in internal or external audits.4.1
  6. Review clinical protocols to ensure collection of data needed for regulatory submissions.4.1
  7. Compile and maintain regulatory documentation databases or systems.4.0
  8. Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.4.0
  9. Recommend changes to company procedures in response to changes in regulations or standards.4.0
  10. Develop or conduct employee regulatory training.3.7
  11. Write or update standard operating procedures, work instructions, or policies.3.6
  12. Develop or track quality metrics.3.5
  13. Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.3.3
  14. Recommend adjudication of product complaints.4.1
  15. Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.3.8
  16. Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.3.8
  17. Direct the collection and preparation of laboratory samples as requested by regulatory agencies.3.7
  18. Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.3.7

Knowledge

Bodies of knowledge the work draws on.

  • English Language4.24.9Level 4 looks like: Edit an article for a news website
  • Law and Government3.94.0Level 4 looks like: Prepare documents and title papers for the purchase of a new house
  • Administration and Management3.44.1Level 4 looks like: Monitor progress of a project to ensure timely completion
  • Administrative3.24.4Level 4 looks like: Type 30 words per minute
  • Computers and Electronics3.23.8Level 4 looks like: Use a computer to format a document
  • Engineering and Technology2.72.6
  • Mathematics2.73.4Level 4 looks like: Analyze data to determine areas with the highest sales
  • Medicine and Dentistry2.72.5Level 1 looks like: Use a band-aid
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  • Biology2.62.8
  • Education and Training2.53.4Level 4 looks like: Lead a quality improvement seminar
  • Production and Processing2.42.5Level 1 looks like: Put a computer back into its packing materials
  • Chemistry2.32.4Level 1 looks like: Use a common household bug spray
  • Communications and Media2.32.4Level 1 looks like: Write a thank you note
  • Customer and Personal Service2.32.3Level 1 looks like: Process a customer's dry-cleaning drop off
  • Design2.32.1Level 1 looks like: Draw a straight line 4 3/16 inches long
  • Public Safety and Security2.32.0Level 1 looks like: Use a seatbelt
  • Personnel and Human Resources2.22.5Level 1 looks like: Fill out a medical claim form
  • Telecommunications2.11.0Level 1 looks like: Send an email
  • Mechanical1.91.1Level 1 looks like: Replace the filters in a furnace
  • Psychology1.91.5Level 1 looks like: Monitor several children on a playground
  • Foreign Language1.81.2Level 1 looks like: Say "please" and "thank you" in a foreign language
  • Geography1.81.8Level 1 looks like: Know the capital of the United States
  • Sales and Marketing1.81.5Level 1 looks like: Sell cakes at a bake sale
  • Physics1.71.2Level 1 looks like: Use a crowbar to pry open a box
  • Transportation1.70.8Level 1 looks like: Ride a train to work
  • Economics and Accounting1.50.9Level 1 looks like: Answer billing questions from credit card customers
  • History and Archeology1.5—
  • Sociology and Anthropology1.51.0Level 1 looks like: Identify two cultures in a story as being different
  • Philosophy and Theology1.4—
  • Therapy and Counseling1.40.8Level 1 looks like: Put ice on a sprained ankle
  • Food Production1.30.6Level 1 looks like: Grow herbs in the kitchen
  • Building and Construction1.2—
  • Fine Arts1.1—

Abilities

Enduring capacities the work calls for.

  • Written Comprehension4.45.0Level 4 looks like: Understand an apartment lease
  • Written Expression4.34.5Level 4 looks like: Write a job recommendation for a subordinate
  • Deductive Reasoning4.04.3Level 5 looks like: Decide what factors to consider in selecting stocks
  • Inductive Reasoning4.04.1Level 4 looks like: Determine the prime suspect based on crime scene evidence
  • Oral Comprehension4.05.0Level 4 looks like: Understand a coach's oral instructions for a sport
  • Oral Expression4.04.8Level 4 looks like: Give instructions to a lost motorist
  • Problem Sensitivity4.04.1Level 4 looks like: Notice from a subtle difference in a client's mood that something is bothering them
  • Information Ordering3.93.9Level 2 looks like: Follow the correct steps to make change
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  • Near Vision3.94.3Level 5 looks like: Read the fine print of a legal document
  • Speech Clarity3.94.0Level 4 looks like: Make stadium-wide announcements during a sporting event
  • Speech Recognition3.94.1Level 4 looks like: Identify a former customer's voice over the phone
  • Category Flexibility3.33.6Level 3 looks like: Classify flowers according to size, color, and smell
  • Fluency of Ideas3.33.8Level 4 looks like: Think of as many ideas as possible for the name of a new company
  • Originality3.03.1Level 4 looks like: Redesign job tasks to be interesting for employees
  • Flexibility of Closure2.93.5Level 4 looks like: Look for a golf ball in tall grass
  • Perceptual Speed2.92.8Level 2 looks like: Sort mail according to ZIP codes with no time pressure
  • Mathematical Reasoning2.82.9
  • Memorization2.82.9
  • Selective Attention2.82.8Level 2 looks like: Answer a business call with coworkers talking nearby
  • Speed of Closure2.83.0Level 3 looks like: Recognize a song after hearing only the first few notes
  • Far Vision2.62.6Level 2 looks like: Read a roadside billboard
  • Number Facility2.42.8Level 3 looks like: Calculate a discounted price
  • Visualization2.12.0Level 2 looks like: Imagine how to place paper in a printer so that the letterhead comes out on top
  • Time Sharing2.01.8Level 2 looks like: Listen to music while entering numbers into a spreadsheet
  • Auditory Attention1.91.5Level 2 looks like: Listen to a lecture while people nearby are talking
  • Trunk Strength1.91.3Level 2 looks like: Sit up in an office chair
  • Visual Color Discrimination1.81.5Level 1 looks like: Separate laundry into colors and whites
  • Finger Dexterity1.61.1Level 2 looks like: Put coins in a parking meter
  • Hearing Sensitivity1.61.1Level 2 looks like: Notice a doorbell ringing
  • Wrist-Finger Speed1.40.4
  • Depth Perception1.1—
  • Spatial Orientation1.1—
  • Arm-Hand Steadiness1.0—
  • Control Precision1.0—
  • Dynamic Flexibility1.0—
  • Dynamic Strength1.0—
  • Explosive Strength1.0—
  • Extent Flexibility1.0—
  • Glare Sensitivity1.0—
  • Gross Body Coordination1.0—
  • Gross Body Equilibrium1.0—
  • Manual Dexterity1.0—
  • Multilimb Coordination1.0—
  • Night Vision1.0—
  • Peripheral Vision1.0—
  • Rate Control1.0—
  • Reaction Time1.0—
  • Response Orientation1.0—
  • Sound Localization1.0—
  • Speed of Limb Movement1.0—
  • Stamina1.0—
  • Static Strength1.0—

Work activities

Kinds of activity the work is made of.

  • Evaluating Information to Determine Compliance with Standards4.75.3Level 4 looks like: Evaluate a complicated insurance claim for compliance with policy terms
  • Getting Information4.65.6
  • Updating and Using Relevant Knowledge4.45.6
  • Working with Computers4.43.5Level 4 looks like: Write software for keeping track of parts in inventory
  • Communicating with Supervisors, Peers, or Subordinates4.34.9Level 4 looks like: Report the results of a sales meeting to a supervisor
  • Making Decisions and Solving Problems4.34.8Level 4 looks like: Select the location for a major retail store
  • Communicating with People Outside the Organization4.25.2Level 4 looks like: Present information to potential clients about available services
  • Documenting/Recording Information4.24.4Level 4 looks like: Document the results of a crime scene investigation
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  • Interpreting the Meaning of Information for Others4.24.7Level 4 looks like: Interpret how foreign tax laws apply to U.S. exports
  • Organizing, Planning, and Prioritizing Work4.25.5Level 4 looks like: Plan and adjust a personal to-do list according to changing demands
  • Analyzing Data or Information4.14.8Level 4 looks like: Determine the interest cost to finance a new building
  • Establishing and Maintaining Interpersonal Relationships4.15.0Level 4 looks like: Maintain good working relationships with almost all coworkers and clients
  • Developing Objectives and Strategies4.04.3Level 4 looks like: Develop the plan to complete the merger of two organizations over a 3-year period
  • Processing Information3.95.3Level 4 looks like: Calculate the adjustments for insurance claims
  • Performing Administrative Activities3.64.1Level 4 looks like: Complete tax forms for a small business
  • Resolving Conflicts and Negotiating with Others3.64.4Level 4 looks like: Get two subordinates to agree about vacation schedules
  • Scheduling Work and Activities3.53.9Level 4 looks like: Prepare the work schedule for salesclerks in a large retail store
  • Thinking Creatively3.54.1Level 4 looks like: Adapt popular music for a high school marching band
  • Identifying Objects, Actions, and Events3.44.5Level 4 looks like: Judge the suitability of food products for an event
  • Providing Consultation and Advice to Others3.44.6Level 4 looks like: Recommend a new software package to increase operational efficiency
  • Training and Teaching Others3.44.1Level 4 looks like: Teach a social sciences course to high school students
  • Coordinating the Work and Activities of Others3.33.9Level 4 looks like: Organize the cleanup crew after a major sporting event
  • Coaching and Developing Others3.23.9Level 4 looks like: Provide on-the-job training for administrative workers
  • Developing and Building Teams3.23.8Level 4 looks like: Lead an assembly team in an automobile plant
  • Guiding, Directing, and Motivating Subordinates3.13.7Level 4 looks like: Manage a small team of employees in a dynamic workplace
  • Judging the Qualities of Objects, Services, or People3.03.6Level 4 looks like: Determine the value of property lost in a fire
  • Monitoring Processes, Materials, or Surroundings2.92.9
  • Staffing Organizational Units2.73.3Level 4 looks like: Interview candidates for a sales position and make hiring recommendations
  • Monitoring and Controlling Resources2.63.0Level 4 looks like: Work as a chef responsible for ordering food for the menu
  • Selling or Influencing Others2.62.5Level 1 looks like: Convince a coworker to assist with an assignment
  • Estimating the Quantifiable Characteristics of Products, Events, or Information2.42.4Level 1 looks like: Estimate the size of household furniture to be shipped
  • Assisting and Caring for Others2.01.4Level 1 looks like: Help a coworker complete an assignment
  • Inspecting Equipment, Structures, or Materials1.91.6Level 1 looks like: Check that doors to building are locked
  • Drafting, Laying Out, and Specifying Technical Devices, Parts, and Equipment1.71.0Level 1 looks like: Specify the lighting for a work area
  • Performing for or Working Directly with the Public1.61.2Level 1 looks like: Check tickets at a concert
  • Controlling Machines and Processes1.5—
  • Handling and Moving Objects1.4—
  • Performing General Physical Activities1.40.7Level 1 looks like: Walk between workstations in a small office
  • Repairing and Maintaining Electronic Equipment1.3—
  • Operating Vehicles, Mechanized Devices, or Equipment1.2—
  • Repairing and Maintaining Mechanical Equipment1.2—

Work context

The conditions most characteristic of the work, on O*NET's 1–5 context scale.

  • E-Mail4.9
  • Spend Time Sitting4.8
  • Work With or Contribute to a Work Group or Team4.8
  • Importance of Being Exact or Accurate4.6
  • Telephone Conversations4.5
  • Indoors, Environmentally Controlled4.4
  • Contact With Others4.3
  • Face-to-Face Discussions with Individuals and Within Teams4.2
  • Coordinate or Lead Others in Accomplishing Work Activities4.0
  • Impact of Decisions on Co-workers or Company Results4.0

Technology

34 tools

Software used in this work. In demand: among the tools job postings for this occupation name most. Hot: often named in job postings across the economy.

In demand (5)

  • Microsoft Excelhot
  • Microsoft Office softwarehot
  • Microsoft Outlookhot
  • Microsoft PowerPointhot
  • Microsoft Wordhot

Hot (10; 5 more marked hot above)

  • Adobe Acrobat
  • Microsoft Access
  • Microsoft Project
  • Microsoft SharePoint
  • Microsoft SQL Server
  • Microsoft Visio
  • Microsoft Visual Basic
  • SAP software
  • Structured query language SQL
  • Yardi software
Other tools (19)
  • Analyse-it
  • Atrion Intelligent Authoring
  • DataVision
  • FileMaker Pro
  • Fund accounting software
  • Healthcare common procedure coding system HCPCS
  • Human resource management software HRMS
  • Integrated development environment IDE software
  • LexisNexis
  • McAfee
  • Medical procedure coding software
  • Microsoft Dynamics
  • MicroStrategy
  • NortonLifeLock cybersecurity software
  • Qlik Tech QlikView
  • Relational database management software
  • Statistical software
  • Tax software
  • Web browser software

Related occupations

O*NET's own list of the occupations most related to this one, closest first.

  1. Regulatory Affairs Managers
  2. Compliance Managers
  3. Environmental Compliance Inspectors
  4. Government Property Inspectors and Investigators
  5. Compliance Officers
  6. Quality Control Systems Managers
  7. Document Management Specialists
  8. Coroners
  9. Equal Opportunity Representatives and Officers
  10. Customs Brokers

ESCO equivalents

From the official ESCO–O*NET crosswalk, strongest match first. A broader occupation takes in this one; a narrower one is a part of it.

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This page includes information from the O*NET 31.0 Database by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license; O*NET® is a trademark of USDOL/ETA. ESCO occupations and skills are from the European Commission's ESCO classification, and the occupation crosswalk is the official ESCO–O*NET mapping by the ESCO Secretariat with USDOL/ETA. This service uses the ESCO classification of the European Commission. BlissPoint Analytics has modified all or some of this information: skill, task and descriptor ratings are rounded to one decimal, and ESCO occupations show Job Zone and interests copied from a crosswalked O*NET occupation. USDOL/ETA has not approved, endorsed, or tested these modifications.