Regulatory specialist vs regulatory affairs associate

The differences between regulatory specialists and regulatory affairs associates can be seen in a few details. Each job has different responsibilities and duties. It typically takes 2-4 years to become both a regulatory specialist and a regulatory affairs associate. Additionally, a regulatory affairs associate has an average salary of $71,154, which is higher than the $70,575 average annual salary of a regulatory specialist.

The top three skills for a regulatory specialist include FDA, regulatory compliance and regulatory agencies. The most important skills for a regulatory affairs associate are regulatory affairs, FDA, and regulatory submissions.

Regulatory specialist vs regulatory affairs associate overview

	Regulatory Specialist	Regulatory Affairs Associate
Yearly salary	$70,575	$71,154
Hourly rate	$33.93	$34.21
Growth rate	-	-
Number of jobs	6,250	9,032
Job satisfaction	5	-
Most common degree	Bachelor's Degree, 62%	Bachelor's Degree, 69%
Average age	46	46
Years of experience	4	4

What does a regulatory specialist do?

A regulatory specialist is responsible for evaluating all the business processes, functions, and requirements and ensure its compliance with the company's protocols and state regulations. Regulatory specialists conduct regular audits, review the company's documents and business transactions, renew permits and licenses, and submit necessary files required by regulatory agencies. They coordinate with the management to revise the company's handbook accordingly and disseminate information on any changes across the organization. A regulatory specialist may also facilitate training programs and orientation to inform the employees on risk policies to avoid reputational issues, potential hazards, and delays in operations.

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.

Regulatory specialist vs regulatory affairs associate salary

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

	Regulatory Specialist	Regulatory Affairs Associate
Average salary	$70,575	$71,154
Salary range	Between $49,000 And $100,000	Between $49,000 And $102,000
Highest paying City	San Francisco, CA	San Rafael, CA
Highest paying state	Minnesota	California
Best paying company	Cargill	Meta
Best paying industry	-	-

Differences between regulatory specialist and regulatory affairs associate education

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

	Regulatory Specialist	Regulatory Affairs Associate
Most common degree	Bachelor's Degree, 62%	Bachelor's Degree, 69%
Most common major	Business	Pharmacy
Most common college	Stanford University	University of Southern California

Regulatory specialist vs regulatory affairs associate demographics

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

	Regulatory Specialist	Regulatory Affairs Associate
Average age	46	46
Gender ratio	Male, 29.9% Female, 70.1%	Male, 30.5% Female, 69.5%
Race ratio	Black or African American, 11.6% Unknown, 4.5% Hispanic or Latino, 15.5% Asian, 8.1% White, 59.5% American Indian and Alaska Native, 0.8%	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%
LGBT Percentage	12%	12%

Differences between regulatory specialist and regulatory affairs associate duties and responsibilities

Regulatory specialist example responsibilities.

Utilize the``SharePoint"system to manage the document change control process and maintain configuration control.
Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
Assess study results for adherence to 40 CFR EPA regulatory requirements.
Stay abreast of developments in GCP and federal regulations regarding clinical research.
Assist with QC and QA of various study relate regulatory documents and reports.
Assist with training and mentoring of junior regulatory specialists and assist with departmental QC and QA activities.

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.

Regulatory specialist vs regulatory affairs associate skills

Common regulatory specialist skills

FDA, 10%
Regulatory Compliance, 8%
Regulatory Agencies, 7%
Regulatory Submissions, 5%
Customer Service, 5%
Clinical Trials, 4%

Common regulatory affairs associate skills

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

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Regulatory Specialist
Regulatory Specialist vs Regulatory Affairs Associate

Updated January 8, 2025

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