Occupations · Management

Regulatory Affairs Managers

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

O*NET 30.3 Database (USDOL/ETA) · occupation code 11-9199.01

What people in this job actually do

Ordered by how important the work is rated.

Develop regulatory strategies and implementation plans for the preparation and submission of new products.
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
Provide responses to regulatory agencies regarding product information or issues.
Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
Manage activities such as audits, regulatory agency inspections, or product recalls.
Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
Maintain current knowledge of relevant regulations, including proposed and final rules.
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Direct documentation efforts to ensure compliance with domestic and international regulations and standards.

O*NET 30.3 task ratings, importance scale

Skills that matter most

Importance, rated 1 to 5.

Writing4.2

Reading Comprehension4.1

Speaking4.0

Active Listening4.0

Critical Thinking3.9

Monitoring3.6

Active Learning3.5

Learning Strategies3.0

Science2.4

Mathematics2.4

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 SharePoint●Microsoft Visio●Microsoft Windows●Microsoft Word●SAP software●Structured query language SQL●Tableau●Adlib ExpressAnalyse-itAris Global RegisterAxway eSubmissionsDatabase softwareDatafarm S-CubedDatafarm a-PulseDatafarm eCTDGatekeeperDatafarm eCTDViewerDialog DialogLinkDocument publishing softwareDoubleBridge ROSETTA Phoenix eCTD ViewerDoubleBridge ROSETTA PyramidDoubleBridge ROSETTA Sceptre

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

Spend Time Using Your Hands to Handle, Control, or Feel Objects, Tools, or Controls−1.8 below average

Exposed to Sounds, Noise Levels that are Distracting or Uncomfortable−1.7 below average

Spend Time Sitting+1.5 above average

Spend Time Standing−1.5 below average

Wear Common Protective or Safety Equipment such as Safety Shoes, Glasses, Gloves, Hearing Protection, Hard Hats, or Life Jackets−1.4 below average

Health and Safety of Other Workers−1.4 below average

Exposed to Contaminants−1.4 below average

O*NET 30.3 work context, frequency scale · observed 2024-08

How people actually get in

Share of workers by the education they hold.

Bachelor's Degree74%

Master's Degree13%

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.4%

Some College Courses4%

O*NET 30.2 education, training and experience · observed 2024-08

What kind of person the work suits

Occupational interest profile, rated 1 to 7.

Enterprising6.5

Conventional5.7

Investigative3.0

O*NET 30.2 occupational interests (RIASEC)

Tasks O*NET flags as emerging

Develop and review regulatory strategies, development plans, and implementation plans for the preparation and submission of new products.

O*NET 30.3 emerging tasks

What you take with you

Skills rated for how well they transfer into other occupations.

Complex Problem Solving3.8

Judgment and Decision Making3.8

Systems Analysis3.8

Systems Evaluation3.8

Time Management3.6

Coordination3.5

Social Perceptiveness3.2

Instructing3.2

O*NET 30.3 transferable skills, importance scale

Knowledge the work draws on

English LanguageLaw and GovernmentAdministration and ManagementBiologyEducation and TrainingAdministrative

Abilities it leans on

Written ExpressionWritten ComprehensionOral ExpressionOral ComprehensionInductive ReasoningDeductive Reasoning

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 ManagerCompliance DirectorRegulatory DirectorRegulatory Process ManagerRegulatory Program ManagerRegulatory Reports ManagerRegulatory Affairs ExecutiveRegulatory Oversight ManagerRegulatory Reporting ManagerRA Manager (Regulatory Affairs Manager)RA Director (Regulatory Affairs Director)RA VP (Regulatory Affairs Vice President)International Regulatory Affairs SpecialistGlobal RA Manager (Global Regulatory Affairs Manager)

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. 2 entries that were only relabelled between releases are left out.

Now listed 11

+SAP software+Microsoft Visio+Structured query language SQL+Microsoft SharePoint+IBM Notes+Microsoft PowerPoint+Microsoft Access+Integrated development environment IDE software+Software development tools+Tableau+Adobe Acrobat

No longer listed 3

−Adobe Systems Adobe Acrobat software−Word processing software−Spreadsheet 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 LeaderRegulatory ManagerRegulatory AnalystRegulatory DirectorCompliance DirectorRegulatory ConsultantRegulatory AdministratorRegulatory Process ManagerRegulatory Reports ManagerRegulatory Affairs ManagerRegulatory Product ManagerRegulatory Program Manager

O*NET 30.3 alternative titles

The same work in Europe

ESCO occupation	ISCO	Match
regulatory affairs manager	2619.10	exact

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

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