Occupations · Business and Financial Operations

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.

O*NET 30.3 Database (USDOL/ETA) · occupation code 13-1041.07

What people in this job actually do

Ordered by how important the work is rated.

Coordinate efforts associated with the preparation of regulatory documents or submissions.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Prepare or maintain technical files as necessary to obtain and sustain product approval.
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
Coordinate recall or market withdrawal activities as necessary.
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
Identify relevant guidance documents, international standards, or consensus standards.

O*NET 30.3 task ratings, importance scale

Skills that matter most

Importance, rated 1 to 5.

Speaking4.0

Active Listening4.0

Writing4.0

Critical Thinking3.9

Reading Comprehension3.9

Active Learning3.2

Monitoring3.2

Learning Strategies3.0

Mathematics2.5

Science1.9

O*NET 30.3 skills, importance scale

Software and tools

A dot marks what O*NET flags as in demand.

Adobe Acrobat●Microsoft Access●Microsoft Excel●Microsoft Office software●Microsoft Outlook●Microsoft PowerPoint●Microsoft Project●Microsoft SQL Server●Microsoft SharePoint●Microsoft Visio●Microsoft Visual Basic●Microsoft Word●SAP software●Structured query language SQL●Yardi software●Analyse-itAtrion Intelligent AuthoringDataVisionFileMaker ProFund accounting softwareHealthcare common procedure coding system HCPCSHuman resource management software HRMSIntegrated development environment IDE softwareLexisNexisMcAfeeMedical procedure coding softwareMicroStrategyMicrosoft Dynamics

O*NET 30.3 software skills · hot-technology flag

What this work is actually like

Conditions rated against the average across all occupations — only what makes this job different is listed.

4 / 5Considerable preparation — a four-year degree plus several years in the field.

O*NET 30.3 Job Zones

Working conditions that stand out

Wear Common Protective or Safety Equipment such as Safety Shoes, Glasses, Gloves, Hearing Protection, Hard Hats, or Life Jackets−1.8 below average

Spend Time Sitting+1.8 above average

Health and Safety of Other Workers−1.7 below average

Spend Time Using Your Hands to Handle, Control, or Feel Objects, Tools, or Controls−1.4 below average

Exposed to Contaminants−1.4 below average

Spend Time Standing−1.4 below average

Outdoors, Exposed to All Weather Conditions−1.3 below average

O*NET 30.3 work context, frequency scale · observed 2019-08

How people actually get in

Share of workers by the education they hold.

Bachelor's Degree80%

Master's Degree10%

Post-Baccalaureate Certificate - awarded for completion of an organized program of study; designed for people who have completed a Baccalaureate degree but do not meet the requirements of academic degrees carrying the title of Master.5%

Post-Doctoral Training5%

O*NET 30.2 education, training and experience · observed 2019-08

What kind of person the work suits

Occupational interest profile, rated 1 to 7.

Conventional6.3

Enterprising4.5

Investigative3.3

O*NET 30.2 occupational interests (RIASEC)

Tasks O*NET flags as emerging

Develop regulatory strategies for products.

O*NET 30.3 emerging tasks

What you take with you

Skills rated for how well they transfer into other occupations.

Judgment and Decision Making3.9

Systems Analysis3.8

Complex Problem Solving3.8

Social Perceptiveness3.4

Time Management3.4

Systems Evaluation3.2

Coordination3.1

Negotiation3.1

O*NET 30.3 transferable skills, importance scale

Knowledge the work draws on

English LanguageLaw and GovernmentBiologyComputers and ElectronicsAdministration and ManagementAdministrative

Abilities it leans on

Written ComprehensionWritten ExpressionOral ComprehensionOral ExpressionSpeech ClarityProblem Sensitivity

O*NET 30.3 abilities and knowledge, importance scale

How this job is advertised

The same work is posted under many titles — this is what to search for.

Regulatory AnalystRegulatory EngineerRegulatory ScientistRegulatory SpecialistRegulatory ConsultantRegulatory CoordinatorProduct Safety SpecialistRegulatory Affairs ScientistRegulatory Reporting AnalystProduct Stewardship SpecialistRegulatory Services ConsultantResearch Compliance SpecialistRegulatory Compliance AssociateRegulatory Submissions Associate

O*NET 30.3 job titles reported for this occupation

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What changed since 2015

Comparing O*NET release 20.1 (2015-10-01) with 30.3 (2026-05-01). Signs, not colour alone, carry the meaning. 3 entries that were only relabelled between releases are left out.

Now listed 20

+Tax software+Microsoft SQL Server+Microsoft Visio+Microsoft Visual Basic+McAfee+Qlik Tech QlikView+Integrated development environment IDE software+Yardi software+Human resource management software HRMS+Relational database management software+Adobe Acrobat+Microsoft SharePoint+Structured query language SQL+NortonLifeLock cybersecurity software

No longer listed 1

−Adobe Systems Adobe Acrobat software

Diff across the O*NET releases held here in full since October 2015, following occupations through merges and retirements. O*NET re-surveys occupations on a rolling cycle, so “no change” can also mean “not re-surveyed”.

O*NET 30.3 related occupations

Also called

Regulatory AnalystCompliance OfficerCompliance AnalystRegulatory EngineerRegulatory ScientistRegulatory AssociateCompliance AssociateCompliance ConsultantCompliance SpecialistRegulatory ConsultantRegulatory SpecialistRegulatory Coordinator

O*NET 30.3 alternative titles

The same work in Europe

ESCO occupation	ISCO	Match
regulatory affairs manager	2619.10	close

Official ESCO ↔ O*NET crosswalk (ESCO Secretariat with USDOL/ETA)

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