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.
职业名称和任务陈述按其发布时的英文原文显示。标签（包括任务类型）为译文。
AI暴露度
- 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
- 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
- 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
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
AI 暴露度（OpenAI 评分标准）
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
任务
来自 O*NET® 31.0 Database 的任务陈述，核心任务在前。
| 任务 | 类型 | β（OpenAI） |
|---|---|---|
| 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 | 0.5 |
| Coordinate, prepare, or review regulatory submissions for domestic or international projects. | 核心 | 0.5 |
| Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. | 核心 | 0.5 |
| Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. | 核心 | 1 |
| Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. | 核心 | 0.5 |
| Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. | 核心 | 0.5 |
| Compile and maintain regulatory documentation databases or systems. | 核心 | 0.5 |
| Coordinate efforts associated with the preparation of regulatory documents or submissions. | 核心 | 0.5 |
| Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. | 核心 | 0.5 |
| Develop or conduct employee regulatory training. | 核心 | 0.5 |
| Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. | 核心 | 0.5 |
| Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. | 核心 | 0.5 |
| Participate in internal or external audits. | 核心 | 0.5 |
| Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. | 核心 | 0.5 |
| Prepare or maintain technical files as necessary to obtain and sustain product approval. | 核心 | 0.5 |
| Recommend changes to company procedures in response to changes in regulations or standards. | 核心 | 0.5 |
| Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. | 核心 | 1 |
| Review clinical protocols to ensure collection of data needed for regulatory submissions. | 核心 | 0.5 |
| Write or update standard operating procedures, work instructions, or policies. | 核心 | 1 |
| Coordinate recall or market withdrawal activities as necessary. | 核心 | 0.5 |
| Develop or track quality metrics. | 核心 | 0.5 |
| Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines. | 核心 | 0.5 |
| Identify relevant guidance documents, international standards, or consensus standards. | 核心 | 0.5 |
| Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors. | 核心 | 0.5 |
| Develop regulatory strategies for products. | 核心 | 未评分 |
| Direct the collection and preparation of laboratory samples as requested by regulatory agencies. | 补充 | 0 |
| Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste. | 补充 | 0.5 |
| Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste. | 补充 | 0.5 |
| Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances. | 补充 | 0.5 |
| Recommend adjudication of product complaints. | 补充 | 0.5 |
职业信息
来源与署名
This page includes information from the O*NET® 31.0 Database (https://www.onetcenter.org/database.html) by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA). Used under the CC BY 4.0 license (https://creativecommons.org/licenses/by/4.0/). O*NET® is a trademark of USDOL/ETA. AI Changing Work has modified all or some of this information: the O*NET-SOC code, title and task statements are reproduced in English without change; task-type labels are shown in the page's language and tasks are listed core first; any Korean occupation title shown on the Korean-language page is AI Changing Work's translation; any KSCO-8 unit groups linked to this occupation were paired with it by AI Changing Work's judgment, and the relation labels and statuses are AI Changing Work's additions. USDOL/ETA has not approved, endorsed, or tested these modifications.
Any AI exposure figures on this page are published by third parties, not by AI Changing Work, and none is part of the O*NET information. OpenAI publishes task-level scores (MIT License) for O*NET 27.2 task statements; each is shown next to the O*NET 31.0 task statement with the same task ID, whose wording can differ from the 27.2 statement that was scored. OpenAI also publishes occupation-level scores for O*NET-SOC codes in the same release, and any such score is shown on the O*NET occupation with the same code. Anthropic publishes an observed exposure index in the Anthropic Economic Index (CC-BY), and the U.S. Bureau of Labor Statistics publishes relative AI exposure categories (public domain); both are published per SOC code, and each value is shown on every O*NET occupation with that code. The International Labour Organization publishes a generative AI exposure index in ILO Working Paper 140 (CC BY 4.0) for ISCO-08 unit groups; AI Changing Work links those groups to O*NET occupations by applying the U.S. Bureau of Labor Statistics ISCO-08 to 2010 SOC and 2010 SOC to 2018 SOC crosswalks as published, without case-by-case selection, and these crosswalks match many groups only in part. Where several unit groups are linked, each group's published value is listed, and any summary shows only the lowest and highest of those values with the number of groups; no exposure figure is averaged or recalculated. Any employment figures are published by the U.S. Bureau of Labor Statistics for the SOC group containing this occupation. Each source is credited where its figures are shown.
O*NET OnLine: 13-1041.07 Regulatory Affairs Specialists
KSCO 코드·명칭: 한국표준직업분류(제8차 개정) — 통계청 고시 제2024-328호 (2024-07-01 고시, 2025-01-01 시행). 저작권법 제7조 제2호의 고시 항목이다. 명칭 표기(가운뎃점·띄어쓰기)는 해설서 2차 정오 반영판의 표기를 따랐으며, 고시 항목표와는 18개 명칭에서 가운뎃점 글리프나 띄어쓰기만 다르다. 통계청은 2025년 10월 국가데이터처로 개편되었다. 이 페이지의 KSCO 연결은 통계청·국가데이터처의 공식 연계표가 아니다.