# 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.

- **SOC code:** 13-1041.07
- **Canonical URL:** https://singulariki.com/roles/role-13-1041-07
- **Also known as:** Regulatory Affairs Associate (RA Associate), Regulatory Affairs Consultant (RA Consultant), Regulatory Affairs Specialist (RA Specialist), Regulatory Engineer, Drug Regulatory Affairs Specialist, Regulatory Affairs Analyst (RA Analyst), Regulatory Affairs Strategist (RA Strategist), Regulatory Services Consultant
- **Frame:** "AI exposure" means task overlap (how codifiable the work is), not jobs lost or a forecast. Every figure below is traced to a named public dataset.

## What this work is

**Core tasks** (O*NET):
- 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.

**Emerging tasks** (O*NET):
- Develop regulatory strategies for products.

## Skills, tools, capabilities

**Knowledge, skills & abilities** (O*NET, highest importance first):
- English Language _(knowledge)_
- Written Comprehension _(ability)_
- Written Expression _(ability)_
- Law and Government _(knowledge)_
- Active Listening _(essential_skill)_
- Writing _(essential_skill)_
- Speaking _(essential_skill)_
- Oral Comprehension _(ability)_
- Oral Expression _(ability)_
- Reading Comprehension _(essential_skill)_
- Critical Thinking _(essential_skill)_
- Judgment and Decision Making _(transferable_skill)_

**Skills in demand:**
- English Language _(Common Skill)_
- Writing _(Common Skill)_
- Active Listening _(Common Skill)_
- Reading Comprehension _(Common Skill)_
- Inductive Reasoning _(Common Skill)_
- Deductive Reasoning _(Common Skill)_
- Critical Thinking _(Common Skill)_
- Systems Analysis _(Specialized Skill)_
- Speech Recognition _(Specialized Skill)_
- Complex Problem Solving _(Common Skill)_
- Information Ordering _(Specialized Skill)_
- Microsoft Word _(Common Skill)_

**Tools & technology:**
- Microsoft Excel _(hot technology, in demand)_
- Microsoft Office software _(hot technology, in demand)_
- Microsoft Outlook _(hot technology, in demand)_
- Microsoft PowerPoint _(hot technology, in demand)_
- Microsoft Word _(hot technology, in demand)_
- Adobe Acrobat _(hot technology)_
- Microsoft Access _(hot technology)_
- Microsoft Project _(hot technology)_
- Microsoft SharePoint _(hot technology)_
- Microsoft SQL Server _(hot technology)_
- Microsoft Visio _(hot technology)_
- Microsoft Visual Basic _(hot technology)_

## AI exposure & outlook

- **AI task-overlap index:** 75th percentile (High) across all occupations — composite of current-era exposure studies (ai-exposure-index-v1).
- **Overall AI exposure (Felten et al.):** 64th percentile (Moderate) — source: felten_aioe.
- **LLM task exposure, γ (OpenAI / Eloundou):** 91st percentile (High) — source: eloundou_gamma.
- **AI assistant applicability (Microsoft):** 67th percentile (High) — source: microsoft_applicability.
- **Frey–Osborne (2013, historical computerization estimate):** 26th percentile — kept separate from current-era studies.
- **Remote-capable (Dingel–Neiman):** yes — task structure, not who actually works remote.
- **Projected employment (BLS 2024–34):** 3.0% growth (About average); 33.3k annual openings; 418k → 430.3k jobs.
- **Pay & employment (BLS OEWS, May 2024):** median $78,420; 397,770 employed.

## How people actually use AI here

Anthropic Economic Index — measured AI conversations mapped to this occupation's tasks:

- **Automation vs augmentation:** 40% automation, 50% augmentation (usage-weighted).
- **Autonomy median:** 3.0 (higher = AI acts more independently).
- **Dominant collaboration mode:** directive.

**Tasks most handed to AI here:**
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. _(0.9% of measured AI use; learning)_
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. _(0.8% of measured AI use; task iteration)_
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. _(0.6% of measured AI use; directive)_

**Example prompts (honest phrasings of the tasks above — starting points, not endorsed instructions):**
- Help me interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Help me prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Help me obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.

## Sources

- **O*NET** (30.3) — U.S. Department of Labor / National Center for O*NET Development. https://www.onetcenter.org/database.html
- **BLS Occupational Employment and Wage Statistics (OEWS)** (May 2024) — U.S. Bureau of Labor Statistics. https://www.bls.gov/oes/
- **BLS Employment Projections** (2024–2034) — U.S. Bureau of Labor Statistics. https://www.bls.gov/emp/
- **Anthropic Economic Index** (v4 (2026-01-15) + v2 (2025-03-27)) — Anthropic. https://www.anthropic.com/economic-index
- **Microsoft “Working with AI”** (working-with-ai) — Microsoft Research. https://www.microsoft.com/en-us/research/
- **“GPTs are GPTs” (Eloundou et al.)** (arXiv 2303.10130) — OpenAI / academic. https://arxiv.org/abs/2303.10130
- **AI Occupational Exposure (AIOE)** (Felten, Raj & Seamans) — academic. https://github.com/AIOE-Data/AIOE
- **Frey & Osborne (2013)** (frey-osborne-automation) — academic. https://www.oxfordmartin.ox.ac.uk/publications/the-future-of-employment/
- **Dingel & Neiman (2020)** (dingel-neiman-workathome) — academic. https://github.com/jdingel/DingelNeiman-workathome

---
_Generated from Singulariki's joined dataset; data snapshot 2026-06-02T21:00:32.945303+00:00. https://singulariki.com/roles/role-13-1041-07_