---
title: "Regulatory Affairs Specialist"
description: "Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare…"
canonical: "https://nuecareer.com/careers/regulatory-affairs-specialist"
last-updated: "2026-08-23T15:56:39.581Z"
---

# Regulatory Affairs Specialist

**Category:** Business and Financial Operations · **SOC code:** 13-1041 · **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.

Also advertised as: Drug Regulatory Affairs Specialist; Regulatory Affairs Analyst (RA Analyst); Regulatory Affairs Associate (RA Associate); Regulatory Affairs Consultant (RA Consultant); Regulatory Affairs Specialist (RA Specialist); Regulatory Affairs Strategist (RA Strategist); Regulatory Engineer; Regulatory Services Consultant.

## At a glance

- **Median annual wage:** $80,730 (BLS OEWS, May 2025)
- **Median hourly wage:** $38.81/hr
- **Wage range (10th–90th percentile):** $48,220 to $133,720, with the middle half between $61,280 and $109,010
- **Total US employment:** 417,070
- **Typical entry education:** Bachelor's
- **Preparation required:** Medium preparation — O\*NET rates this "Job Zone Four: Considerable Preparation Needed"
- **Projected growth:** +3.0% over 2024–2034 (BLS EP, 2024–2034)
- **Annual job openings:** 33,300 openings a year
- **AI-resilience score:** 13/100 — a NueCareer heuristic over O\*NET work activities and context, not a BLS or O\*NET figure

## Pay

National wage distribution, BLS OEWS, May 2025, across 417,070 US jobs.

| Percentile | Annual wage |
| --- | --- |
| 10th | $48,220 |
| 25th | $61,280 |
| 50th (median) | $80,730 |
| 75th | $109,010 |
| 90th | $133,720 |
| Mean (average) | $88,400 |

### Pay by state

The 15 highest-paying states, by median annual wage. The cost-of-living-adjusted column divides the state median by that state's BEA Regional Price Parity, so the columns answer different questions: the first is what the job pays there, the second is what that pay buys there.

| State | Median annual wage | Cost-of-living adjusted | Employment |
| --- | --- | --- | --- |
| DC | $111,030 | $101,027 | 4,380 |
| MA | $102,060 | $96,504 | 13,190 |
| NJ | $100,000 | $91,908 | 13,310 |
| CA | $96,980 | $87,590 | 49,880 |
| CT | $91,810 | $88,611 | 3,610 |
| DE | $91,050 | $91,225 | 2,150 |
| VT | $90,420 | $92,305 | 1,960 |
| NY | $90,080 | $83,468 | 23,500 |
| WA | $88,790 | $82,971 | 11,130 |
| RI | $87,620 | $85,667 | 970 |
| MN | $85,920 | $87,121 | 6,140 |
| PA | $85,580 | $87,710 | 19,810 |
| MD | $84,720 | $80,717 | 10,100 |
| ME | $83,740 | $86,285 | 1,790 |
| OR | $82,990 | $80,291 | 5,360 |

39 more states with published wage data are omitted here. The full table for all 54 states is at https://nuecareer.com/careers/regulatory-affairs-specialist/salary-by-state, or as JSON at https://nuecareer.com/api/v1/careers/regulatory-affairs-specialist.

## Outlook

BLS projects employment to move from 418,000 in the 2024–2034 base year to 430,300 by the end of the cycle — a gain of 12,300 jobs, or +3.0%. About as fast as average: 3.0% against 3.1% projected for all occupations over the same cycle. About 33,300 openings a year are expected on average, counting openings from growth as well as from workers leaving the occupation permanently. Source: BLS EP, 2024–2034.

## How to get in

- **Typical entry education:** Bachelor's degree (BLS Employment Projections).
- **Preparation level:** Medium preparation — O\*NET's preparation band for this occupation is "Job Zone Four: Considerable Preparation Needed".
- **Related work experience typically required:** None.
- **Typical on-the-job training:** Moderate-term on-the-job training.

### Education people in this job actually hold

O\*NET surveys incumbents, so this distribution describes who is in the job today and can differ from the BLS entry requirement above.

| Education level | Share of workers |
| --- | --- |
| Bachelor's Degree | 80.0% |
| Master's Degree | 10.0% |
| Post-Baccalaureate Certificate | 5.0% |
| Post-Doctoral Training | 5.0% |

## What the work involves

- 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.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

## Skills and knowledge

### Essential skills

- Active Listening — importance 4.0 on the O\*NET 1–5 importance scale
- Writing — importance 4.0 on the O\*NET 1–5 importance scale
- Speaking — importance 4.0 on the O\*NET 1–5 importance scale
- Reading Comprehension — importance 3.9 on the O\*NET 1–5 importance scale
- Critical Thinking — importance 3.9 on the O\*NET 1–5 importance scale
- Active Learning — importance 3.3 on the O\*NET 1–5 importance scale
- Monitoring — importance 3.3 on the O\*NET 1–5 importance scale
- Learning Strategies — importance 3.0 on the O\*NET 1–5 importance scale

### Transferable skills

These are the skills that carry into other occupations, and they drive the related-occupation and career-change rankings on this site.

- Judgment and Decision Making — importance 3.9 on the O\*NET 1–5 importance scale
- Complex Problem Solving — importance 3.8 on the O\*NET 1–5 importance scale
- Systems Analysis — importance 3.8 on the O\*NET 1–5 importance scale
- Social Perceptiveness — importance 3.4 on the O\*NET 1–5 importance scale
- Time Management — importance 3.4 on the O\*NET 1–5 importance scale
- Systems Evaluation — importance 3.3 on the O\*NET 1–5 importance scale
- Coordination — importance 3.1 on the O\*NET 1–5 importance scale
- Negotiation — importance 3.1 on the O\*NET 1–5 importance scale

### Knowledge areas

- English Language — importance 4.5 on the O\*NET 1–5 importance scale
- Law and Government — importance 4.1 on the O\*NET 1–5 importance scale
- Biology — importance 3.5 on the O\*NET 1–5 importance scale
- Computers and Electronics — importance 3.4 on the O\*NET 1–5 importance scale
- Administration and Management — importance 3.4 on the O\*NET 1–5 importance scale
- Administrative — importance 3.2 on the O\*NET 1–5 importance scale

### Abilities

- Written Comprehension — importance 4.3 on the O\*NET 1–5 importance scale
- Written Expression — importance 4.1 on the O\*NET 1–5 importance scale
- Oral Comprehension — importance 4.0 on the O\*NET 1–5 importance scale
- Oral Expression — importance 4.0 on the O\*NET 1–5 importance scale
- Problem Sensitivity — importance 3.9 on the O\*NET 1–5 importance scale
- Deductive Reasoning — importance 3.9 on the O\*NET 1–5 importance scale

## Who it suits

O\*NET rates every occupation on the six Holland (RIASEC) interest areas, on a 1–7 scale. This occupation's strongest areas are Conventional (C), Enterprising (E), Investigative (I).

| Interest area | Score (1–7) |
| --- | --- |
| C — Conventional | 6.32 |
| E — Enterprising | 4.46 |
| I — Investigative | 3.32 |
| S — Social | 2.50 |
| R — Realistic | 1.40 |
| A — Artistic | 1.00 |

### Personality fit

These scores are **derived by NueCareer**, not published by any government agency: they are cosine similarities between a personality type's trait profile and this occupation's O\*NET interest and work-style ratings, expressed 0–100. Treat them as a starting point for exploration, not as evidence that a type belongs in a job.

| Type | Fit score (0–100) |
| --- | --- |
| ESTJ | 80.7 |
| ISTJ | 73.3 |
| ESFJ | 72.3 |
| ISFJ | 69.7 |
| ENTJ | 65.3 |

Best-fitting types: ESTJ.

## Related occupations

O\*NET's primary related occupations, in its own ranked order.

- [Regulatory Affairs Manager](https://nuecareer.com/careers/regulatory-affairs-manager) — median $141,900
- [Compliance Manager](https://nuecareer.com/careers/compliance-manager) — median $141,900
- [Environmental Compliance Inspector](https://nuecareer.com/careers/environmental-compliance-inspector) — median $80,730
- [Government Property Inspector and Investigator](https://nuecareer.com/careers/government-property-inspector-and-investigator) — median $80,730
- [Compliance Officer](https://nuecareer.com/careers/compliance-officer) — median $80,730
- [Quality Control Systems Manager](https://nuecareer.com/careers/quality-control-systems-manager) — median $126,060
- [Document Management Specialist](https://nuecareer.com/careers/document-management-specialist) — median $116,580
- [Coroner](https://nuecareer.com/careers/coroner) — median $80,730
- [Equal Opportunity Representative and Officer](https://nuecareer.com/careers/equal-opportunity-representative-and-officer) — median $80,730
- [Customs Broker](https://nuecareer.com/careers/customs-broker) — median $80,730

## Sources

- **O\*NET** — O\*NET 30.3 Database, May 2026. https://www.onetcenter.org/database.html
- **BLS OEWS** — BLS Occupational Employment and Wage Statistics, May 2025. https://www.bls.gov/oes/
- **BLS EP** — BLS Employment Projections, Table 1.2, 2024–2034. https://www.bls.gov/emp/
- **BLS OOH** — BLS Occupational Outlook Handbook, 2024–2034 edition. https://www.bls.gov/ooh/
- **BEA RPP** — BEA Regional Price Parities by State, 2024. https://www.bea.gov/data/prices-inflation/regional-price-parities-state-and-metro-area

---

This bank includes information from the O\*NET 30.3 Database 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. NueCareer has transformed the data by joining it to BLS wage and projection data and deriving facet, personality-fit and AI-resilience scores. BLS and BEA data are public domain (17 U.S.C. §105).

O\*NET content is used under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). How these figures are sourced and derived: https://nuecareer.com/careers/methodology

JSON representation of this page: https://nuecareer.com/api/v1/careers/regulatory-affairs-specialist