Regulatory affairs associate vs specialist

The differences between regulatory affairs associates and specialists can be seen in a few details. Each job has different responsibilities and duties. While it typically takes 2-4 years to become a regulatory affairs associate, becoming a specialist takes usually requires 1-2 years. Additionally, a regulatory affairs associate has an average salary of $71,154, which is higher than the $58,013 average annual salary of a specialist.

The top three skills for a regulatory affairs associate include regulatory affairs, FDA and regulatory submissions. The most important skills for a specialist are patients, customer service, and work ethic.

Regulatory affairs associate vs specialist overview

	Regulatory Affairs Associate	Specialist
Yearly salary	$71,154	$58,013
Hourly rate	$34.21	$27.89
Growth rate	-	10%
Number of jobs	9,032	358,433
Job satisfaction	-	-
Most common degree	Bachelor's Degree, 69%	Bachelor's Degree, 49%
Average age	46	42
Years of experience	4	2

What does a regulatory affairs associate do?

A regulatory affairs associate is in charge of learning and implementing company policies and government regulations, ensuring compliance in every aspect of the company. Their responsibilities revolve around coordinating with different departments to gather data, conducting inspections and assessments, reviewing existing procedures, liaising with external agencies, and producing progress reports. They may also participate in instructing employees of the standards one must uphold. Furthermore, as a regulatory affairs associate, it is essential to develop guidelines and standards on every procedure in adherence to the latest policies and regulations.

What does a specialist do?

Specialists are employees who are responsible for specific tasks or activities in the department they are assigned to. The actions or tasks they work on are related to their educational background or work experiences. They are usually highly skilled in specializations related to the work they are assigned to. Specialists are also highly trained on the competencies that are required of their specialty. As such, they are focused on the skills and competencies that are needed to enhance their experience in their specific field further.

Regulatory affairs associate vs specialist salary

Regulatory affairs associates and specialists have different pay scales, as shown below.

	Regulatory Affairs Associate	Specialist
Average salary	$71,154	$58,013
Salary range	Between $49,000 And $102,000	Between $32,000 And $104,000
Highest paying City	San Rafael, CA	Jersey City, NJ
Highest paying state	California	New Jersey
Best paying company	Meta	The Citadel
Best paying industry	-	-

Differences between regulatory affairs associate and specialist education

There are a few differences between a regulatory affairs associate and a specialist in terms of educational background:

	Regulatory Affairs Associate	Specialist
Most common degree	Bachelor's Degree, 69%	Bachelor's Degree, 49%
Most common major	Pharmacy	Business
Most common college	University of Southern California	Stanford University

Regulatory affairs associate vs specialist demographics

Here are the differences between regulatory affairs associates' and specialists' demographics:

	Regulatory Affairs Associate	Specialist
Average age	46	42
Gender ratio	Male, 30.5% Female, 69.5%	Male, 47.5% Female, 52.5%
Race ratio	Black or African American, 11.1% Unknown, 4.5% Hispanic or Latino, 15.8% Asian, 8.3% White, 59.5% American Indian and Alaska Native, 0.8%	Black or African American, 11.4% Unknown, 5.4% Hispanic or Latino, 16.4% Asian, 10.5% White, 55.9% American Indian and Alaska Native, 0.4%
LGBT Percentage	12%	11%

Differences between regulatory affairs associate and specialist duties and responsibilities

Regulatory affairs associate example responsibilities.

Manage CQA vendor deliverables and liaise with vendors to identify and remedy GCP compliance issues with active sites.
Manage the compliance education tracking and documentation process for international GMP education.
Manage eCTD submission preparation by negotiating data requirements and deliverable dates with internal technical teams.
Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
Develop all require QMS procedures complying the requirements of 21 CFR 820 and ISO 13485.
Help prepare & maintain FDA submit regulatory documents with a team of others, as well as place them in eCTD.

Specialist example responsibilities.

Create, manage, and assist users with SharePoint sites.
Manage an on-site IRB and company good clinical practice (GCP) inspection.
Manage SharePoint sites by creating, editing, and customizing company sites, libraries and security.
Manage the building of accounts, assigning of static IP's, and scheduling of business class installations.
Convert servers from UNIX to Linux, all hardware diagnostics and repair including printers/plotters/desktops etc.
Follow safety procedures such as maintenance of all equipment (Telxon scanners, terminals and ladders).

Regulatory affairs associate vs specialist skills

Common regulatory affairs associate skills

Regulatory Affairs, 12%
FDA, 9%
Regulatory Submissions, 8%
Medical Devices, 6%
Global Regulatory, 5%
Regulatory Agencies, 4%

Common specialist skills

Patients, 15%
Customer Service, 11%
Work Ethic, 5%
Patient Care, 4%
Exceptional Client, 4%
Troubleshoot, 4%

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Regulatory Affairs Associate
Regulatory Affairs Associate vs Specialist

Updated January 8, 2025

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