Regulatory Affairs Specialists

Career Overview

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 Known As

• Regulatory Affairs Associate (RA Associate)
• Regulatory Affairs Consultant (RA Consultant)
• Regulatory Affairs Specialist (RA Specialist)
• Regulatory Engineer

Alternate Job Titles

• Anti Money Laundering Compliance Analyst (AML Compliance Analyst)
• Clinical Quality Assurance Associate
• Clinical Quality Assurance Specialist
• CMC Regulatory Affairs Manager (Chemistry, Manufacturing, and Controls Regulatory Affairs Manager)
• Drug Regulatory Affairs Specialist
• Product Safety Specialist
• Product Stewardship Specialist
• Quality Assurance Documentation Coordinator
• Quality Assurance Documentation Specialist
• Regulatory Affairs Analyst (RA Analyst)
• Regulatory Affairs Associate (RA Associate)
• Regulatory Affairs Consultant (RA Consultant)
• Regulatory Affairs Coordinator (RA Coordinator)
• Regulatory Affairs Scientist
• Regulatory Affairs Specialist (RA Specialist)

What You'll Do

In this role, your typical responsibilities include:

• 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.

Emerging Responsibilities

As this field evolves, you may also:

• Develop regulatory strategies for products.

Knowledge You'll Use

You'll need solid knowledge in these areas:

• English Language
• Law and Government

Essential Skills

Success in this career requires strong skills in:

1. Active Listening
2. Writing
3. Speaking
4. Reading Comprehension
5. Critical Thinking
6. Judgment and Decision Making
7. Complex Problem Solving
8. Systems Analysis

Key Abilities

This career requires key abilities in:

• Written Comprehension
• Written Expression
• Oral Comprehension
• Oral Expression
• Deductive Reasoning
• Inductive Reasoning
• Speech Clarity
• Problem Sensitivity
• Speech Recognition
• Information Ordering

Work Style

People who excel in this career typically demonstrate:

• Attention to Detail
• Dependability
• Cautiousness
• Integrity
• Intellectual Curiosity

What Matters in This Career

This career tends to satisfy these work values:

• Working Conditions
• Independence
• Achievement
• Support
• Recognition

Education & Preparation

Typical Education: Bachelor's Degree

Related Work Experience Needed: Over 2 years, up to and including 4 years

On-the-Job Training: Over 3 months, up to and including 6 months

Education Details: Most of these occupations require a four-year bachelor's degree, but some do not.

Experience Required: A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.

Technology You'll Use

Popular Technologies & Software

• Adobe Acrobat
• Microsoft Access
• Microsoft Excel
• Microsoft Office software
• Microsoft Outlook
• Microsoft PowerPoint
• Microsoft Project
• Microsoft SharePoint
• Microsoft SQL Server
• Microsoft Visio

Tools & Equipment

• Computer data input scanners
• Desktop computers
• Laptop computers
• Laser facsimile machines
• Multi-line telephone systems
• Personal computers
• Photocopying equipment

Work Environment

• E-Mail
• Spend Time Sitting
• Indoors, Environmentally Controlled
• Work With or Contribute to a Work Group or Team
• Face-to-Face Discussions with Individuals and Within Teams

Salary & Job Market

Wages reported for the broader Compliance Officers occupational group (BLS 2024), which includes Regulatory Affairs Specialists.

Salary Percentile	Annual Wage
Entry-Level (10th percentile)	$46,230
Median	$78,420
Top Earners (90th percentile)	$130,030

Workers Employed Nationally: 397,770

Related Careers

If you're interested in this career, you might also consider:

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Occupational data sourced from the O*NET OnLine database, developed by the U.S. Department of Labor, Employment and Training Administration. Wage data from the U.S. Bureau of Labor Statistics Occupational Employment and Wage Statistics (OEWS), 2024.