O*NET-SOC 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.

From O*NET 30.3

Tasks

From O*NET 30.3, by importance, as O*NET OnLine lists them

Free · O*NET 30.3

Coordinate efforts associated with the preparation of regulatory documents or submissions.Core18054
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.Core18045
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.Core18061
Coordinate, prepare, or review regulatory submissions for domestic or international projects.Core18048
Prepare or maintain technical files as necessary to obtain and sustain product approval.Core18062
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.Core18049
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.Core18055
Coordinate recall or market withdrawal activities as necessary.Core18067
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.Core18052
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.Core18070
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.Core18051
Identify relevant guidance documents, international standards, or consensus standards.Core21094
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.Core18050
Review clinical protocols to ensure collection of data needed for regulatory submissions.Core18065
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.Core21095
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.Core18058
Recommend changes to company procedures in response to changes in regulations or standards.Core18063
Participate in internal or external audits.Core18060
Compile and maintain regulatory documentation databases or systems.Core18053
Write or update standard operating procedures, work instructions, or policies.Core18066
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.Core18059
Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.Supplemental19553
Develop or track quality metrics.Core18068
Develop or conduct employee regulatory training.Core18056
Recommend adjudication of product complaints.Core21096
Direct the collection and preparation of laboratory samples as requested by regulatory agencies.Supplemental18069
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.Supplemental18064
Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.Supplemental19557
Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.Supplemental19552
Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.Supplemental19554

Technology Skills

From O*NET 30.3, 34 examples in 21 categories, 15 Hot Technology

Free · O*NET 30.3

Document management software

Adobe AcrobatHot Technology
Atrion Intelligent Authoring
Microsoft SharePointHot Technology

Analytical or scientific software

Analyse-it
Statistical software

Data base reporting software

DataVision

Data base user interface and query software

FileMaker Pro
Microsoft AccessHot Technology
Microsoft SQL ServerHot Technology
Structured query language SQLHot Technology
Yardi softwareHot Technology

Accounting software

Fund accounting software
Tax software

Medical software

Healthcare common procedure coding system HCPCS
Medical procedure coding software

Human resources software

Human resource management software HRMS

Development environment software

Integrated development environment IDE software
Microsoft Visual BasicHot Technology

Information retrieval or search software

LexisNexis

Transaction security and virus protection software

McAfee
NortonLifeLock cybersecurity software

Enterprise resource planning ERP software

Microsoft Dynamics
SAP softwareHot Technology

Spreadsheet software

Microsoft ExcelHot TechnologyIn Demand

Office suite software

Microsoft Office softwareHot TechnologyIn Demand

Electronic mail software

Microsoft OutlookHot TechnologyIn Demand

Presentation software

Microsoft PowerPointHot TechnologyIn Demand

Project management software

Microsoft ProjectHot Technology

Process mapping and design software

Microsoft VisioHot Technology

Word processing software

Microsoft WordHot TechnologyIn Demand

Business intelligence and data analysis software

MicroStrategy
Qlik Tech QlikView

Data base management system software

Relational database management software

Internet browser software

Web browser software

Detailed Work Activities

From O*NET 30.3, under their work activities; open one for the AI skills Workforce Automation maps to it

Free · O*NET 30.3

Getting Information

Obtain documentation to authorize activities.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet
Investigate system, equipment, or product failures.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Monitoring Processes, Materials, or Surroundings

Monitor business indicators.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Processing Information

Compile technical information or documentation.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Evaluating Information to Determine Compliance with Standards

Examine product information to ensure compliance with regulations.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet
Review documents or materials for compliance with policies or regulations.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet
Examine financial records or processes.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Analyzing Data or Information

Analyze data to identify or resolve operational problems.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet
Analyze environmental regulations to ensure organizational compliance.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet
Evaluate applicable laws and regulations to determine impact on organizational activities.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Updating and Using Relevant Knowledge

Update knowledge of legal or regulatory environments.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Developing Objectives and Strategies

Establish organizational guidelines or policies.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Documenting/Recording Information

Prepare financial documents.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 2 of 2 AI skills mapped to this activity, by automation level
- Augments 2
- Harvest automationclaudeskills.infoAugments
- Latex documentndpvt-web/latex-document-skill317 installsAugments
  Gen Agent Trust Hub Fail
  Runlayer Fail
  Snyk Warn
  Socket Pass
  ZeroLeaks Pass
Maintain data in information systems or databases.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 5 of 23 AI skills mapped to this activity, by automation level
- Replaces 3
- Augments 17
- Supports 2
- Informs 1
- Agent memory architectureclaudeskills.infoReplaces
- Prismic automationclaudeskills.infoReplaces
- Contentful automationclaudeskills.infoReplaces
- Knowledge opsaffaan-m/everything-claude-code8,594 installsAugments
  Gen Agent Trust Hub Pass
  Snyk Warn
  Socket Pass
  ZeroLeaks Pass
- Google sheetsclaudeskills.infoAugments
Prepare regulatory or compliance documentation.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Interpreting the Meaning of Information for Others

Explain regulations, policies, or procedures.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Performing for or Working Directly with the Public

Correspond with customers to answer questions or resolve complaints.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Coordinating the Work and Activities of Others

Communicate with government agencies.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet
Coordinate regulatory documentation activities.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Training and Teaching Others

Train personnel in organizational or compliance procedures.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Guiding, Directing, and Motivating Subordinates

Oversee business processes.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Providing Consultation and Advice to Others

Recommend changes or corrective procedures.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet
Advise others on legal or regulatory compliance matters.
WFA · Part of the paid plan when accounts open
WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level
- No tools yet
- Not mapped yet

Job Zone

From O*NET 30.3

Free · O*NET 30.3

Job Zone Four: Considerable Preparation Needed

Workforce Automation analysis, not part of the source

WFA coverage: AI skills for this job

WFA · Part of the paid plan when accounts open

Pilot mapping: these skill links come from our seed list and haven’t been reviewed yet. Expect them to change as each one is checked.

DWAs covered by an AI skill2 of 23

Distinct tools25

Level mix

Replaces 3
Augments 19
Supports 2
Informs 1

Equivalents

NICE work roles, with their DCWF equivalents

Mapped to this job by the ETO-CSET NICE/O*NET crosswalk (2024); roles from NICE Framework Components v2.2.0, DCWF equivalents from DoD DCWF Tool v5.3 (2026-09-25)

Free · NICE Framework Components v2.2.0 and DoD DCWF Tool v5.3 (2026-09-25)

No NICE work role maps to this job.