# Regulatory Affairs Managers

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

- **SOC code:** 11-9199.01
- **Canonical URL:** https://singulariki.com/roles/role-11-9199-01
- **Also known as:** Compliance Director, Global RA Manager (Global Regulatory Affairs Manager), RA Director (Regulatory Affairs Director), RA Manager (Regulatory Affairs Manager), CMC Director (Chemistry, Manufacturing, and Controls Director), Global RA Director (Global Regulatory Affairs Director), RA QA Director (Regulatory Affairs Quality Assurance Director), RA VP (Regulatory Affairs Vice President)
- **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):
- 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.

**Emerging tasks** (O*NET):
- Develop and review regulatory strategies, development plans, and implementation plans for the preparation and submission of new products.

## Skills, tools, capabilities

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

**Skills in demand:**
- English Language _(Common Skill)_
- Writing _(Common Skill)_
- Reading Comprehension _(Common Skill)_
- Active Listening _(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)_
- Time Management _(Common Skill)_
- Information Ordering _(Specialized 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)_
- Adobe Acrobat _(hot technology)_
- Microsoft Access _(hot technology)_
- Microsoft Project _(hot technology)_
- Microsoft SharePoint _(hot technology)_
- Microsoft Visio _(hot technology)_
- Microsoft Windows _(hot technology)_
- Microsoft Word _(hot technology)_
- SAP software _(hot technology)_

## AI exposure & outlook

- **AI task-overlap index:** 73rd percentile (High) across all occupations — composite of current-era exposure studies (ai-exposure-index-v1).
- **Overall AI exposure (Felten et al.):** 72nd percentile (High) — source: felten_aioe.
- **LLM task exposure, γ (OpenAI / Eloundou):** 95th percentile (High) — source: eloundou_gamma.
- **AI assistant applicability (Microsoft):** 49th percentile (Moderate) — source: microsoft_applicability.
- **Frey–Osborne (2013, historical computerization estimate):** 37th percentile — kept separate from current-era studies.
- **Remote-capable (Dingel–Neiman):** yes — task structure, not who actually works remote.
- **Projected employment (BLS 2024–34):** 4.5% growth (About average); 106.7k annual openings; 1,333.7k → 1,393.5k jobs.
- **Pay & employment (BLS OEWS, May 2024):** median $136,550; 630,980 employed.

## How people actually use AI here

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

- **Automation vs augmentation:** 13% automation, 47% augmentation (usage-weighted).
- **Autonomy median:** 3.0 (higher = AI acts more independently).
- **Dominant collaboration mode:** learning.

**Tasks most handed to AI here:**
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. _(0.8% of measured AI use; learning)_
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met. _(0.8% of measured AI use; directive)_
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. _(0.4% of measured AI use)_

**Example prompts (honest phrasings of the tasks above — starting points, not endorsed instructions):**
- Help me provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Help me review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Help me represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.

## 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

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_Generated from Singulariki's joined dataset; data snapshot 2026-06-02T21:00:32.945303+00:00. https://singulariki.com/roles/role-11-9199-01_
