Regulatory Affairs Specialists

Business and Financial Operations Occupations

O*NET-SOC 代码: 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.

数据来源: BLS发布时间: 2026-08
很高· 相对
低四级相对区间很高
职业群单位数值
尺度 · 母数 · 来源
四级相对类别（低 / 中等 / 高 / 很高）
以BLS就业预测表中831个细分职业为基数。取值按 NEM（全国就业矩阵）代码给定，因此共用同一 NEM 代码的职业得到相同分档
来源数据集（XLSX 文件下载）
数据来源: Anthropic发布时间: 2026-03
0.121
0.000此处所载数值的范围0.745
职业群单位数值
尺度 · 母数 · 来源
观测暴露度指数，按发布原值0–1
以O*NET任务映射为基准
按 SOC 2018 职业发布的数值；具有相同 SOC 2018 代码的所有 O*NET 职业均显示此值
来源数据集（CSV 文件下载）
数据来源: ILO发布时间: 2025
0.32–0.45· ISCO-08 职业组 3 个
尺度 · 母数 · 来源
生成式AI暴露度指数，按发布原值0–1
按 ISCO-08 细类（4 位）发布的数值。按原样应用美国劳工统计局（BLS）的官方对照表（ISCO-08→2010 SOC、2010 SOC→2018 SOC）关联到本职业，对应关系为全部或部分对应
来源数据集（PDF 文件下载）

该来源发布的是什么性质的数值

BLS的类别是相对排位而非绝对水平，也不是一手测量：它把多项已发表研究给出的职业百分位排名归并为四个等级。它不是就业或工资预测，不是采用概率，也不区分自动化与增强。

各关联 ISCO-08 职业组的 ILO 数值

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

Task-level exposure

仅显示有暴露的工作

已评分任务 32 项 · β ≥ 0.5 的任务 31 项（96.9%）

β = 直接暴露（E1）+ 0.5 × 借助工具时的暴露（E2），依据原始代码库的定义。

原始单位：O*NET 27.2 任务 → O*NET 31.0 职业代码
已评分任务中有 3 项不在 O*NET 31.0 任务列表中，其分数按 O*NET 27.2 的发布值保留。

来源: OpenAI "GPTs are GPTs" exposure rubric
版本: gh-main-0471612
许可: MIT License, Copyright (c) 2024 OpenAI

Task (O*NET 20.1)	Claude.aiRaw / share %
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. 13-1041.07	0.036041.5
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. 13-1041.07	0.021224.5
Review clinical protocols to ensure collection of data needed for regulatory submissions. 13-1041.07	0.012214.1
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. 13-1041.07	0.00485.6
Analyze product complaints and make recommendations regarding their reportability. 13-1041.07	0.00475.4
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. 13-1041.07	0.00343.9
Compile and maintain regulatory documentation databases or systems. 13-1041.07	0.00222.6
Write or update standard operating procedures, work instructions, or policies. 13-1041.07	0.00212.4
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
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 regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.	—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
再显示 21 项工作 ▾收起 ▴
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

O*NET 31.0 全部任务（30 项）

本职业在 O*NET 31.0 中的全部任务（英文原文；任务类型为核心或补充）。暴露值不列在此清单中，而在上方表格里，位于各来源所用 O*NET 版本的任务表述旁。

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

就业展望（BLS）

这些数值属于整个 SOC 13-1041 组（Compliance officers），并非仅属于该 O*NET 职业。

就业人数，2025: 436K
预计就业人数，2035: 453K
变化 (2025–35): +3.8%
年薪中位数，2025: $80,730
入职通常所需学历: Bachelor's degree

最低 $30,890BLS EP 2025–35 中 825 个细分职业的工资中位数范围最高 $559,030

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

韩国职业分类关联（KSCO）

来自 AI Changing Work 制作的 Korea Occupation Direct Crosswalk v1.1 当前版本的关联。关系值从 O*NET-SOC 职业一侧解读。

KSCO 代码	KSCO 名称	关系	状态
28153	품질 인증 심사 전문가	有重叠，但不相同	已确认
28159	그 외 경영 및 진단 전문가	相关，但不对应	已确认

关系与状态的定义(kr-direct v1.1)

国际劳工组织（ILO）职业说明

以下 ISCO-08 职业组由 AI Changing Work 原样套用美国劳工统计局（BLS）发布的对照表（2018 SOC→2010 SOC、2010 SOC→ISCO-08）、不逐案取舍，与本职业相关联；每项关联可能是完全对应，也可能是部分对应。

ISCO-08 3351Customs and Border Inspectors
海关和边境检查员
ISCO-08 3353Government Social Benefits Officials
政府社会福利官员
ISCO-08 3354Government Licensing Officials
政府许可审批官员

自行翻译

自行翻译 · 非 ISCO 官方词汇 — 未经国际劳工组织审核。

Sources: ILO ISCO-08 — details: Credits

ESCO 职业词汇

以下每一项都是在已公开的ESCO-O*NET Crosswalk（第 1 版，2022 年）中与本职业逐项对应的。对应类型出自该对照表；表述出自 AI Changing Work。

regulatory affairs managerESCO 2619.10有重叠，但不相同
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.

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

许可: CC BY 4.0 (EU Reuse Notice)

查看原文

ESCO reuse terms and the modification notice are in Credits.

法国职业分类关联（ROME）

本职业与 ROME 4.0 职业条目（fiche）之间的关联，由 AI Changing Work 借助 AI 模型判定。关系从本职业一侧解读。标为「暂定」的关联仅凭同一模型系列（Claude）两位判定者的判定采纳，或对其判定适用运营方规则后采纳，因此其依据弱于已确认的关联。

ROME 代码	ROME 名称（法语）	关系
H1507	Chargé / Chargée des affaires réglementaires	范围相同暂定
H1529	Chargé / Chargée de matériovigilance	本职业范围更宽
H1514	Chargé / Chargée de pharmacovigilance en industrie pharmaceutique	相关，但不对应
H1509	Responsable des affaires règlementaires en industrie pharmaceutique	相关，但不对应暂定

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)

西班牙职业分类关联（CNO-11）

本职业与 CNO-11 职业之间的关联，由 AI Changing Work 借助 AI 模型判定。关系从本职业一侧解读。

CNO-11 代码	CNO-11 名称（西班牙语）	关系
2622	Especialistas en administración de política de empresas	相关，但不对应

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)

德国职业分类关联（KldB）

本职业与 KldB 职业之间的关联，由 AI Changing Work 借助 AI 模型判定。关系从本职业一侧解读。

KldB 代码	KldB 名称（德语）	关系
81884	Berufe in der Pharmazie (sonstige spezifische Tätigkeitsangabe) - hoch komplexe Tätigkeiten	有重叠，但不相同暂定
71384	Berufe in der Unternehmensorganisation und -strategie (sonstige spezifische Tätigkeitsangabe) - hoch komplexe Tätigkeiten	相关，但不对应
27184	Berufe in der technischen Forschung und Entwicklung (sonstige spezifische Tätigkeitsangabe) - hoch komplexe Tätigkeiten	相关，但不对应暂定

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)

日本职业分类关联（JSCO）

本职业与 JSCO 职业之间的关联，由 AI Changing Work 借助 AI 模型判定。关系从本职业一侧解读。

JSCO 代码	JSCO 名称（日语）	关系
259	その他の一般事務従事者	本职业范围更窄
159	他に分類されない保健医療従事者	相关，但不对应

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)

本页数据的来源与许可，以及 AI Changing Work 的修改与翻译说明：致谢与来源