BlissPoint Analytics

Occupation AtlasRegulatory Affairs Managers

O*NET · 11-9199.01

Regulatory Affairs Managers

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

Also called CMC Director · CMC Director (Chemistry, Manufacturing, and Controls Director) · CMC Regulatory Affairs Manager · CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager) · Compliance Director · Global RA Director · Global RA Director (Global Regulatory Affairs Director) · Global RA Manager
26 more

Global RA Manager (Global Regulatory Affairs Manager) · International Regulatory Affairs Specialist · RA and Compliance Director · RA and Compliance Director (Regulatory Affairs and Compliance Director) · RA Director · RA Director (Regulatory Affairs Director) · RA Manager · RA Manager (Regulatory Affairs Manager) · RA QA Director · RA QA Director (Regulatory Affairs Quality Assurance Director) · RA VP · RA VP (Regulatory Affairs Vice President) · Regulatory Affairs Executive · Regulatory Affairs PM · Regulatory Affairs Project Manager (Regulatory Affairs PM) · Regulatory Director · Regulatory Manager · Regulatory Operations Manager (Regulatory Ops Manager) · Regulatory Ops Manager · Regulatory Oversight Manager · Regulatory Process Manager · Regulatory Program Manager · Regulatory Reporting Manager · Regulatory Reports Manager · Vaccine RA Director · Vaccine RA Director (Vaccine Regulatory Affairs Director)

Job Zone 4 — Considerable Preparation NeededHolland code ECI35 skills on file

Compare with another occupationCompare with Climate Change Policy Analysts

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

ECIEnterprising · Conventional · Investigative — the three strongest interests, in order

  • E Enterprising6.55
  • C Conventional5.67
  • I Investigative2.99
  • S Social2.65
  • R Realistic1.93
  • A Artistic1.34

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.

  • Some College Courses4%
  • Bachelor's Degree74%
  • Post-Baccalaureate Certificate4%
  • Master's Degree13%
  • Doctoral Degree4%
Related work experience
Over 2 years, up to and including 4 years (35%)
On-site or in-plant training
Over 1 month, up to and including 3 months (30%)
On-the-job training
Over 6 months, up to and including 1 year (27%)

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.

  • Writingbasic4.34.1Level 4 looks like: Write an email to staff outlining new directives
  • Reading Comprehensionbasic4.14.1Level 4 looks like: Understand an email from management describing new personnel policies
  • Speakingbasic4.04.1Level 4 looks like: Interview applicants to obtain personal and work history
  • Active Listeningbasic4.04.0Level 4 looks like: Answer inquiries regarding credit references
  • Critical Thinkingbasic3.94.0Level 4 looks like: Evaluate customer complaints and determine appropriate responses
  • Judgment and Decision Making3.84.0Level 4 looks like: Evaluate a loan application for degree of risk
  • Systems Analysis3.83.9Level 4 looks like: Determine how a new piece of equipment will affect production rates
  • Systems Evaluation3.83.8Level 4 looks like: Identify the reasons why a client might be unhappy with a product
  • Complex Problem Solving3.83.3Level 4 looks like: Redesign a floor layout to take advantage of new manufacturing techniques
  • Monitoringbasic3.64.1Level 4 looks like: Monitor a meeting and revise the agenda to ensure important topics are discussed
  • Time Management3.63.8Level 4 looks like: Allocate the time of subordinates to projects for the coming week
  • Active Learningbasic3.53.8Level 4 looks like: Determine the impact of new menu changes on a restaurant's purchasing requirements
Show the other 23

Tasks

26 core · 1 supplemental

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

  1. Develop regulatory strategies and implementation plans for the preparation and submission of new products.4.7
  2. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.4.6
  3. Direct the preparation and submission of regulatory agency applications, reports, or correspondence.4.5
  4. Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.4.5
  5. Provide responses to regulatory agencies regarding product information or issues.4.4
  6. Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.4.4
  7. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.4.3
  8. Manage activities such as audits, regulatory agency inspections, or product recalls.4.2
  9. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.4.1
  10. Maintain current knowledge of relevant regulations, including proposed and final rules.4.1
  11. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.4.0
  12. Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.4.0
Show the other 15
  1. Direct documentation efforts to ensure compliance with domestic and international regulations and standards.4.0
  2. Participate in the development or implementation of clinical trial protocols.3.9
  3. Establish regulatory priorities or budgets and allocate resources and workloads.3.8
  4. Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.3.8
  5. Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.3.8
  6. Train staff in regulatory policies or procedures.3.7
  7. Develop and maintain standard operating procedures or local working practices.3.7
  8. Contribute to the development or implementation of business unit strategic and operating plans.3.5
  9. Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.3.5
  10. Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.3.4
  11. Coordinate internal discoveries and depositions with legal department staff.3.4
  12. Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.3.3
  13. Monitor regulatory affairs trends related to environmental issues.3.2
  14. Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.3.1
  15. Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.2.6

Knowledge

Bodies of knowledge the work draws on.

  • English Language4.64.8Level 4 looks like: Edit an article for a news website
  • Law and Government4.04.1Level 4 looks like: Prepare documents and title papers for the purchase of a new house
  • Administration and Management3.74.7Level 4 looks like: Monitor progress of a project to ensure timely completion
  • Biology3.44.0Level 4 looks like: Investigate the effects of pollution on marine plants and animals
  • Education and Training3.14.6Level 4 looks like: Lead a quality improvement seminar
  • Administrative3.03.9Level 4 looks like: Type 30 words per minute
  • Chemistry3.03.7Level 4 looks like: Use the proper concentration of chlorine to purify a water source
  • Computers and Electronics2.93.6Level 4 looks like: Use a computer to format a document
Show all 33
  • Medicine and Dentistry2.82.7
  • Mathematics2.73.4Level 4 looks like: Analyze data to determine areas with the highest sales
  • Production and Processing2.73.0Level 4 looks like: Supervise an appliance assembly line
  • Design2.62.9
  • Engineering and Technology2.62.9
  • Personnel and Human Resources2.53.3Level 4 looks like: Interview applicants for an administrative position
  • Customer and Personal Service2.32.4Level 1 looks like: Process a customer's dry-cleaning drop off
  • Public Safety and Security2.31.7Level 1 looks like: Use a seatbelt
  • Communications and Media2.12.1Level 1 looks like: Write a thank you note
  • Physics2.12.0Level 1 looks like: Use a crowbar to pry open a box
  • Foreign Language2.02.0Level 1 looks like: Say "please" and "thank you" in a foreign language
  • Mechanical2.01.9Level 1 looks like: Replace the filters in a furnace
  • Sales and Marketing2.02.4Level 1 looks like: Sell cakes at a bake sale
  • Psychology1.92.1Level 1 looks like: Monitor several children on a playground
  • Economics and Accounting1.81.4Level 1 looks like: Answer billing questions from credit card customers
  • Telecommunications1.81.0Level 1 looks like: Send an email
  • Sociology and Anthropology1.71.8Level 1 looks like: Identify two cultures in a story as being different
  • Building and Construction1.61.1Level 1 looks like: Choose the proper type of wood for adding a deck onto a house
  • Geography1.51.7Level 1 looks like: Know the capital of the United States
  • Therapy and Counseling1.51.0Level 1 looks like: Put ice on a sprained ankle
  • Food Production1.4—
  • Transportation1.40.9Level 1 looks like: Ride a train to work
  • Philosophy and Theology1.3—
  • History and Archeology1.2—
  • Fine Arts1.1—

Abilities

Enduring capacities the work calls for.

  • Written Expression4.34.1Level 4 looks like: Write a job recommendation for a subordinate
  • Oral Comprehension4.14.1Level 4 looks like: Understand a coach's oral instructions for a sport
  • Oral Expression4.14.1Level 4 looks like: Give instructions to a lost motorist
  • Written Comprehension4.14.3Level 4 looks like: Understand an apartment lease
  • Deductive Reasoning3.94.0Level 5 looks like: Decide what factors to consider in selecting stocks
  • Inductive Reasoning3.94.0Level 4 looks like: Determine the prime suspect based on crime scene evidence
  • Near Vision3.83.9
  • Problem Sensitivity3.84.0Level 4 looks like: Notice from a subtle difference in a client's mood that something is bothering them
Show all 52
  • Speech Clarity3.83.8Level 4 looks like: Make stadium-wide announcements during a sporting event
  • Speech Recognition3.83.9Level 4 looks like: Identify a former customer's voice over the phone
  • Information Ordering3.63.8Level 2 looks like: Follow the correct steps to make change
  • Fluency of Ideas3.13.6Level 4 looks like: Think of as many ideas as possible for the name of a new company
  • Category Flexibility3.03.0Level 3 looks like: Classify flowers according to size, color, and smell
  • Originality3.03.1Level 4 looks like: Redesign job tasks to be interesting for employees
  • Flexibility of Closure2.93.0Level 2 looks like: Detect that your phone is ringing while at a concert
  • Selective Attention2.92.8Level 2 looks like: Answer a business call with coworkers talking nearby
  • Far Vision2.82.8Level 2 looks like: Read a roadside billboard
  • Perceptual Speed2.62.6Level 2 looks like: Sort mail according to ZIP codes with no time pressure
  • Speed of Closure2.62.6Level 3 looks like: Recognize a song after hearing only the first few notes
  • Time Sharing2.62.4Level 2 looks like: Listen to music while entering numbers into a spreadsheet
  • Mathematical Reasoning2.42.5Level 1 looks like: Determine how much 20 oranges will cost when they are priced at 5 for 4 dollars
  • Number Facility2.42.6Level 3 looks like: Calculate a discounted price
  • Memorization2.32.6
  • Auditory Attention2.01.4Level 2 looks like: Listen to a lecture while people nearby are talking
  • Hearing Sensitivity2.01.1Level 2 looks like: Notice a doorbell ringing
  • Visual Color Discrimination2.01.6Level 1 looks like: Separate laundry into colors and whites
  • Visualization2.01.9Level 2 looks like: Imagine how to place paper in a printer so that the letterhead comes out on top
  • Trunk Strength1.91.1Level 2 looks like: Sit up in an office chair
  • Depth Perception1.50.5
  • Wrist-Finger Speed1.50.5
  • Finger Dexterity1.40.5
  • Dynamic Strength1.3—
  • Arm-Hand Steadiness1.0—
  • Control Precision1.0—
  • Dynamic Flexibility1.0—
  • 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—
  • Spatial Orientation1.0—
  • Speed of Limb Movement1.0—
  • Stamina1.0—
  • Static Strength1.0—

Work activities

Kinds of activity the work is made of.

  • Communicating with People Outside the Organization4.75.7
  • Evaluating Information to Determine Compliance with Standards4.76.0Level 7 looks like: Make a ruling in court on a complicated motion
  • Communicating with Supervisors, Peers, or Subordinates4.65.7
  • Interpreting the Meaning of Information for Others4.65.3Level 4 looks like: Interpret how foreign tax laws apply to U.S. exports
  • Getting Information4.55.9
  • Making Decisions and Solving Problems4.55.3Level 4 looks like: Select the location for a major retail store
  • Updating and Using Relevant Knowledge4.45.7
  • Working with Computers4.43.4Level 4 looks like: Write software for keeping track of parts in inventory
Show all 41
  • Documenting/Recording Information4.34.8Level 4 looks like: Document the results of a crime scene investigation
  • Identifying Objects, Actions, and Events4.35.3Level 4 looks like: Judge the suitability of food products for an event
  • Processing Information4.35.6
  • Analyzing Data or Information4.25.1Level 4 looks like: Determine the interest cost to finance a new building
  • Establishing and Maintaining Interpersonal Relationships4.25.5Level 4 looks like: Maintain good working relationships with almost all coworkers and clients
  • Developing Objectives and Strategies4.04.7Level 4 looks like: Develop the plan to complete the merger of two organizations over a 3-year period
  • Organizing, Planning, and Prioritizing Work4.05.7
  • Providing Consultation and Advice to Others3.74.8Level 4 looks like: Recommend a new software package to increase operational efficiency
  • Coaching and Developing Others3.54.5Level 4 looks like: Provide on-the-job training for administrative workers
  • Developing and Building Teams3.54.0Level 4 looks like: Lead an assembly team in an automobile plant
  • Resolving Conflicts and Negotiating with Others3.55.1Level 4 looks like: Get two subordinates to agree about vacation schedules
  • Thinking Creatively3.54.5Level 4 looks like: Adapt popular music for a high school marching band
  • Training and Teaching Others3.54.3Level 4 looks like: Teach a social sciences course to high school students
  • Coordinating the Work and Activities of Others3.44.4Level 4 looks like: Organize the cleanup crew after a major sporting event
  • Guiding, Directing, and Motivating Subordinates3.44.7Level 4 looks like: Manage a small team of employees in a dynamic workplace
  • Monitoring Processes, Materials, or Surroundings3.34.0Level 4 looks like: Test electrical circuits
  • Scheduling Work and Activities3.34.7Level 4 looks like: Prepare the work schedule for salesclerks in a large retail store
  • Judging the Qualities of Objects, Services, or People3.23.9Level 4 looks like: Determine the value of property lost in a fire
  • Estimating the Quantifiable Characteristics of Products, Events, or Information3.03.4Level 4 looks like: Estimate the time required to evacuate a city in the event of a major disaster
  • Performing Administrative Activities3.04.0Level 4 looks like: Complete tax forms for a small business
  • Selling or Influencing Others3.03.7Level 4 looks like: Make a sales pitch to convince others to buy a product
  • Staffing Organizational Units2.83.6Level 4 looks like: Interview candidates for a sales position and make hiring recommendations
  • Monitoring and Controlling Resources2.73.2Level 4 looks like: Work as a chef responsible for ordering food for the menu
  • Inspecting Equipment, Structures, or Materials2.22.4Level 1 looks like: Check that doors to building are locked
  • Assisting and Caring for Others2.12.0Level 1 looks like: Help a coworker complete an assignment
  • Performing for or Working Directly with the Public1.71.5Level 1 looks like: Check tickets at a concert
  • Performing General Physical Activities1.60.8Level 1 looks like: Walk between workstations in a small office
  • Controlling Machines and Processes1.40.5Level 1 looks like: Operate a cash register
  • Drafting, Laying Out, and Specifying Technical Devices, Parts, and Equipment1.41.0Level 1 looks like: Specify the lighting for a work area
  • Handling and Moving Objects1.30.7Level 1 looks like: Change settings on copy machines
  • Repairing and Maintaining Electronic Equipment1.2—
  • Operating Vehicles, Mechanized Devices, or Equipment1.1—
  • Repairing and Maintaining Mechanical Equipment1.0—

Work context

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

  • E-Mail5.0
  • Work With or Contribute to a Work Group or Team4.7
  • Face-to-Face Discussions with Individuals and Within Teams4.6
  • Spend Time Sitting4.6
  • Telephone Conversations4.5
  • Importance of Being Exact or Accurate4.4
  • Contact With Others4.2
  • Indoors, Environmentally Controlled4.2
  • Coordinate or Lead Others in Accomplishing Work Activities4.0
  • Determine Tasks, Priorities and Goals4.0

Technology

67 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 (4)

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

Hot (10; 4 more marked hot above)

  • Adobe Acrobat
  • Microsoft Access
  • Microsoft Project
  • Microsoft SharePoint
  • Microsoft Visio
  • Microsoft Windows
  • Microsoft Word
  • SAP software
  • Structured query language SQL
  • Tableau
Other tools (53)
  • Adlib Express
  • Analyse-it
  • Aris Global Register
  • Axway eSubmissions
  • Database software
  • Datafarm a-Pulse
  • Datafarm eCTDGatekeeper
  • Datafarm eCTDViewer
  • Datafarm S-Cubed
  • Dialog DialogLink
  • Document publishing software
  • DoubleBridge ROSETTA Phoenix eCTD Viewer
  • DoubleBridge ROSETTA Pyramid
  • DoubleBridge ROSETTA Sceptre
  • DoubleBridge ROSETTA Scribe
  • Electronic common technical document eCTD software
  • Electronic common technical document eCTD validating software
  • Electronic common technical document eCTD viewing software
  • Electronic document management system EDMS
  • Enterprise content management ECM software
  • Extedo DOCvalidator
  • Extedo eCTDmanager Suite
  • Extedo PLmanager
  • GlobalSubmit REVIEW
  • GlobalSubmit VALIDATE
  • IBM Notes
  • Image Solutions eCTDXpress
  • Image Solutions ISIPublisher
  • Integrated development environment IDE software
  • Lorenz DocuBridge
  • Lorenz eValidator
  • Lorenz labelBridge
  • MasterControl software
  • MediRegs E-dition Compliance Monitor
  • MediRegs Pharmaceutical Regulation Suite
  • MediRegs Regulation and Reimbursement Suite
  • MediRegs Risk Assessment Manager
  • MedXView eCTDauditor
  • Octagon StartingPoint
  • Octagon ViewPoint eCTD Complete
  • Pilgrim Regulatory Submission
  • Risk management software
  • Samarind RMS
  • SAP EHS Management
  • Software development tools
  • Statistical analysis software
  • Take Solutions PharmaReady Document Management System
  • Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD
  • Thomson Reuters Liquent InSight Suite
  • Total quality management TQM software
  • Virtify eCTD
  • Web browser software
  • XML authoring software

Related occupations

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

  1. Regulatory Affairs Specialists
  2. Compliance Managers
  3. Environmental Compliance Inspectors
  4. Management Analysts
  5. Clinical Data Managers
  6. Financial Risk Specialists
  7. Administrative Services Managers
  8. Quality Control Systems Managers
  9. Project Management Specialists
  10. Compliance Officers

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.

Closest occupations

Compare any occupation →

Other O*NET occupations whose importance ratings on the 35 skills both rate are nearest to this one's, with the biggest differences named. A plain rule, not a hidden score.

Use this in your own job architecture

BlissPoint Organization Viewer can link a role directly to this occupation and suggest these skills as that role's starting requirements.

Try it free →

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.