Regulatory Affairs Specialists

Business and Financial Operations Occupations

O*NET-SOC code: 13-1041.07

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.

Data source: BLSPublished: 2026-08
Very high· relative
LowFour relative bandsVery high
Group-level value
Scale, basis and source
Four relative bands (Low / Moderate / High / Very high)
831 detailed occupations in the BLS Employment Projections table. Assigned per National Employment Matrix (NEM) code, so occupations sharing a NEM code carry the same band
Source dataset (XLSX download)
Data source: AnthropicPublished: 2026-03
0.121
0.000Range of values carried here0.745
Group-level value
Scale, basis and source
Observed exposure index, 0–1 as published
Mapped onto O*NET tasks
Published per SOC 2018 occupation; every O*NET occupation with the same SOC 2018 code carries this value
Source dataset (CSV download)
Data source: ILOPublished: 2025
0.32–0.45· 3 ISCO-08 groups
Scale, basis and source
Generative AI exposure index, 0–1 as published
Published per ISCO-08 unit group. Linked to this occupation, wholly or in part, by applying U.S. Bureau of Labor Statistics crosswalks (ISCO-08 to 2010 SOC, 2010 SOC to 2018 SOC) as published
Source dataset (PDF download)

What kind of figure this source publishes

The BLS category is a relative rank, not an absolute level, and it is not a first-hand measurement: it groups an occupation's percentile ranks across several published studies into four bands. It is not an employment or wage forecast, not a probability of adoption, and it does not separate automation from augmentation.

ILO value for each linked ISCO-08 group

ISCO-08 3351Customs and Border Inspectors0.32
ISCO-08 3353Government Social Benefits Officials0.45
ISCO-08 3354Government Licensing Officials0.43

Task-level exposure

Exposed tasks only

32 rated tasks · 31 tasks with β ≥ 0.5 (96.9%)

β = direct exposure (E1) + 0.5 × exposure when tools are available (E2), per the source repository's definition.

Source unit: O*NET 27.2 tasks → O*NET 31.0 occupation code
3 rated tasks are not in the O*NET 31.0 task list; their scores are kept as published for O*NET 27.2.

Source: OpenAI "GPTs are GPTs" exposure rubric
Release: gh-main-0471612
License: MIT License, Copyright (c) 2024 OpenAI

Task (O*NET 20.1)	Claude.aiRaw / share %
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. 13-1041.07	0.041956.4
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. 13-1041.07	0.009813.1
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. 13-1041.07	0.007510.1
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. 13-1041.07	0.00425.7
Review clinical protocols to ensure collection of data needed for regulatory submissions. 13-1041.07	0.00405.4
Analyze product complaints and make recommendations regarding their reportability. 13-1041.07	0.00293.9
Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste. 13-1041.07	0.00263.5
Compile and maintain regulatory documentation databases or systems. 13-1041.07	0.00152.1
Not observed on any surface — 24 task(s) — These tasks have no row in the source for this release. The 0 in the share row is a display-stage composition ratio; absence is what the — in the raw row states.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.	—0
Escort government inspectors during inspections and provide post-inspection follow-up information as requested.	—0
Coordinate, prepare, or review regulatory submissions for domestic or international projects.	—0
Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.	—0
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.	—0
Coordinate efforts associated with the preparation of regulatory documents or submissions.	—0
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.	—0
Develop or conduct employee regulatory training.	—0
Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.	—0
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.	—0
Participate in internal or external audits.	—0
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.	—0
Prepare or maintain technical files as necessary to obtain and sustain product approval.	—0
Recommend changes to company procedures in response to changes in regulations or standards.	—0
Write or update standard operating procedures, work instructions, or policies.	—0
Coordinate recall or market withdrawal activities as necessary.	—0
Develop or track quality metrics.	—0
Direct the collection and preparation of laboratory samples as requested by regulatory agencies.	—0
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.	—0
Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.	—0
Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.	—0
Monitor national or international legislation on ozone-depleting substances or global warming.	—0
Obtain clearances for the use of recycled plastics in product packaging.	—0
Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.	—0

Values in this tab are predicted labels, not observations. Eloundou et al. (2023) published two rating regimes — human raters and GPT-4 — and the β shown here is derived from the GPT-4 rater basis alone; the same task can take a different value under the other regime. The unit and the meaning differ from the observed shares (%) in the other tabs, so do not place them on the same axis.

Task (O*NET 27.2)	βE1 + 0.5 × E2
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. O*NET Task ID 18050	1.0
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. O*NET Task ID 18064	1.0
Write or update standard operating procedures, work instructions, or policies. O*NET Task ID 18066	1.0
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. O*NET Task ID 18045	0.5
Coordinate, prepare, or review regulatory submissions for domestic or international projects. O*NET Task ID 18048	0.5
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. O*NET Task ID 18049	0.5
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. O*NET Task ID 18051	0.5
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. O*NET Task ID 18052	0.5
Compile and maintain regulatory documentation databases or systems. O*NET Task ID 18053	0.5
Coordinate efforts associated with the preparation of regulatory documents or submissions. O*NET Task ID 18054	0.5
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. O*NET Task ID 18055	0.5
Develop or conduct employee regulatory training. O*NET Task ID 18056	0.5
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. O*NET Task ID 18058	0.5
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. O*NET Task ID 18059	0.5
Participate in internal or external audits. O*NET Task ID 18060	0.5
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. O*NET Task ID 18061	0.5
Prepare or maintain technical files as necessary to obtain and sustain product approval. O*NET Task ID 18062	0.5
Recommend changes to company procedures in response to changes in regulations or standards. O*NET Task ID 18063	0.5
Review clinical protocols to ensure collection of data needed for regulatory submissions. O*NET Task ID 18065	0.5
Coordinate recall or market withdrawal activities as necessary. O*NET Task ID 18067	0.5
Develop or track quality metrics. O*NET Task ID 18068	0.5
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines. O*NET Task ID 18070	0.5
Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste. O*NET Task ID 19552	0.5
Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste. O*NET Task ID 19553	0.5
Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances. O*NET Task ID 19554	0.5
Monitor national or international legislation on ozone-depleting substances or global warming. O*NET Task ID 19555	0.5
Obtain clearances for the use of recycled plastics in product packaging. O*NET Task ID 19556	0.5
Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops. O*NET Task ID 19557	0.5
Identify relevant guidance documents, international standards, or consensus standards. O*NET Task ID 21094	0.5
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors. O*NET Task ID 21095	0.5
Recommend adjudication of product complaints. O*NET Task ID 21096	0.5
Show 21 more tasks ▾Show less ▴
Direct the collection and preparation of laboratory samples as requested by regulatory agencies. O*NET Task ID 18069	0.0

β = E1 + 0.5 × E2 · E1 = tasks where direct LLM access alone cuts time by at least 50%, E2 = tasks where software built on top of an LLM cuts time by at least 50%. Values take only 0 / 0.5 / 1.0.

Data sources & licenses — O*NET®, Anthropic Economic Index, Eloundou et al. (2023): see full notices on the Credits page

All O*NET 31.0 task statements (30)

All O*NET 31.0 task statements for this occupation (English, as published; task type core or supplemental). Exposure values are not listed here; they are in the table above, next to each task statement as worded in the O*NET version each source used.

Task (O*NET 31.0)	Type
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.	Core
Coordinate, prepare, or review regulatory submissions for domestic or international projects.	Core
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.	Core
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.	Core
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.	Core
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.	Core
Compile and maintain regulatory documentation databases or systems.	Core
Coordinate efforts associated with the preparation of regulatory documents or submissions.	Core
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.	Core
Develop or conduct employee regulatory training.	Core
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.	Core
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.	Core
Participate in internal or external audits.	Core
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.	Core
Prepare or maintain technical files as necessary to obtain and sustain product approval.	Core
Recommend changes to company procedures in response to changes in regulations or standards.	Core
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.	Core
Review clinical protocols to ensure collection of data needed for regulatory submissions.	Core
Write or update standard operating procedures, work instructions, or policies.	Core
Coordinate recall or market withdrawal activities as necessary.	Core
Develop or track quality metrics.	Core
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.	Core
Identify relevant guidance documents, international standards, or consensus standards.	Core
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.	Core
Develop regulatory strategies for products.	Core
Direct the collection and preparation of laboratory samples as requested by regulatory agencies.	Supplemental
Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.	Supplemental
Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.	Supplemental
Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.	Supplemental
Recommend adjudication of product complaints.	Supplemental

Employment outlook (BLS)

Values for the whole SOC 13-1041 group (Compliance officers), not for this O*NET occupation alone.

Employment, 2025: 436K
Projected employment, 2035: 453K
Change (2025–35): +3.8%
Median annual wage, 2025: $80,730
Typical education needed for entry: Bachelor's degree

lowest $30,890median wage across 825 detailed occupations, BLS EP 2025–35highest $559,030

Source: U.S. Bureau of Labor Statistics, Employment Projections 2025–35 — Employment by detailed occupation, 2025 and projected 2035

Korea classification links (KSCO)

Links from the current release of the Korea Occupation Direct Crosswalk v1.1, made by AI Changing Work. Relation values are read from the O*NET-SOC occupation side.

KSCO code	KSCO title	Relation	Status
28153	품질 인증 심사 전문가	Overlapping, not the same	confirmed
28159	그 외 경영 및 진단 전문가	Related, not a match	confirmed

Relation and status definitions(kr-direct v1.1)

ILO occupational description

AI Changing Work links the ISCO-08 unit groups below to this occupation by applying the U.S. Bureau of Labor Statistics crosswalks (2018 SOC to 2010 SOC, 2010 SOC to ISCO-08) as published, without case-by-case selection; each link may be whole or partial.

ISCO-08 3351Customs and Border Inspectors
ISCO-08 3353Government Social Benefits Officials
ISCO-08 3354Government Licensing Officials

Sources: ILO ISCO-08 — details: Credits

ESCO occupational vocabulary

Each entry below is matched to this occupation in the published ESCO-O*NET Crosswalk (version 1, 2022). The match types are that crosswalk's; the wording is AI Changing Work's.

regulatory affairs managerESCO 2619.10Overlapping, not the same
Regulatory affairs managers are in charge of regulatory and legal affairs in several sectors such as the healthcare, energy and banking industries. They oversee the development of products and services from inception to market release by making sure everything complies with the local legislation and meets regulatory requirements. They have experience in the different phases of regulatory processes and act as an interface between business and government legislation or regulatory boards.

Source: European Commission, DG EMPL — ESCO API 2026-08-08 (bridge v1.2.1)

License: CC BY 4.0 (EU Reuse Notice)

View original

ESCO reuse terms and the modification notice are in Credits.

France classification links (ROME)

AI Changing Work's links between this occupation and ROME 4.0 job profiles, judged with AI models. Relations are read from this occupation's side. Links marked “provisional” were adopted on the judgments of two judges from the same model family (Claude) alone, or by an operator rule applied to their judgments, so they rest on weaker evidence than confirmed links.

ROME code	ROME title (French)	Relation
H1507	Chargé / Chargée des affaires réglementaires	Same scopeprovisional
H1529	Chargé / Chargée de matériovigilance	This occupation is broader
H1514	Chargé / Chargée de pharmacovigilance en industrie pharmaceutique	Related, not a match
H1509	Responsable des affaires règlementaires en industrie pharmaceutique	Related, not a matchprovisional

Source: France Travail — Répertoire Opérationnel des Métiers et des Emplois (ROME 4.0), version 61, last updated 15 June 2026 (https://www.data.gouv.fr/datasets/repertoire-operationnel-des-metiers-et-des-emplois-rome). Licence Ouverte 2.0.

ROME codes and titles are reproduced unchanged; the links to O*NET-SOC occupations are AI Changing Work's own judgment and are not a France Travail correspondence.

(AI Changing Work link release: fr-direct v1)

Spain classification links (CNO-11)

AI Changing Work's links between this occupation and CNO-11 occupations, judged with AI models. Relations are read from this occupation's side.

CNO-11 code	CNO-11 title (Spanish)	Relation
2622	Especialistas en administración de política de empresas	Related, not a match

Source: Instituto Nacional de Estadística (INE), National Classification of Occupations 2011 (CNO-11, Royal Decree 1591/2010) — www.ine.es · Licensed CC BY 4.0. CNO-11 codes and Spanish titles are reproduced unchanged; the links to O*NET occupations are AI Changing Work's own judgment and are not an INE correspondence.

(AI Changing Work link release: es-direct v1)

Germany classification links (KldB)

AI Changing Work's links between this occupation and KldB occupations, judged with AI models. Relations are read from this occupation's side.

KldB code	KldB title (German)	Relation
81884	Berufe in der Pharmazie (sonstige spezifische Tätigkeitsangabe) - hoch komplexe Tätigkeiten	Overlapping, not the sameprovisional
71384	Berufe in der Unternehmensorganisation und -strategie (sonstige spezifische Tätigkeitsangabe) - hoch komplexe Tätigkeiten	Related, not a match
27184	Berufe in der technischen Forschung und Entwicklung (sonstige spezifische Tätigkeitsangabe) - hoch komplexe Tätigkeiten	Related, not a matchprovisional

Source: © Statistik der Bundesagentur für Arbeit — Klassifikation der Berufe 2010 – überarbeitete Fassung 2020, https://statistik.arbeitsagentur.de. KldB codes and titles are reproduced unchanged; the links to O*NET occupations are AI Changing Work's own mapping (eigene Zuordnung) and are not a Bundesagentur für Arbeit correspondence.

(AI Changing Work link release: de-direct v1)

Japan classification links (JSCO)

AI Changing Work's links between this occupation and JSCO occupations, judged with AI models. Relations are read from this occupation's side.

JSCO code	JSCO title (Japanese)	Relation
259	その他の一般事務従事者	This occupation is narrower
159	他に分類されない保健医療従事者	Related, not a match

Source: Ministry of Internal Affairs and Communications (MIC), Japan Standard Occupational Classification (Dec. 2009, MIC Notification No. 555). JSCO codes and Japanese titles are reproduced unchanged; the links to O*NET occupations are AI Changing Work's own judgment and are not a MIC correspondence.

(AI Changing Work link release: jp-direct v1)

Sources, licenses and AI Changing Work's modification and translation notices for this page: Credits & sources