Regulatory affairs associate vs regulatory affairs manager

The differences between regulatory affairs associates and regulatory affairs managers 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 affairs associate and a regulatory affairs manager. Additionally, a regulatory affairs manager has an average salary of $117,714, which is higher than the $71,154 average annual salary of a regulatory affairs associate.

The top three skills for a regulatory affairs associate include regulatory affairs, FDA and regulatory submissions. The most important skills for a regulatory affairs manager are regulatory affairs, FDA, and medical devices.

Regulatory affairs associate vs regulatory affairs manager overview

	Regulatory Affairs Associate	Regulatory Affairs Manager
Yearly salary	$71,154	$117,714
Hourly rate	$34.21	$56.59
Growth rate	-	-
Number of jobs	9,032	12,569
Job satisfaction	-	-
Most common degree	Bachelor's Degree, 69%	Bachelor's Degree, 64%
Average age	46	47
Years of experience	4	4

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 regulatory affairs manager do?

A regulatory affairs manager is in charge of ensuring that all aspects of a company adhere to the rules and regulations set by regulatory agencies. Their responsibilities revolve around devising regulation compliance strategies, creating training and orientation programs to inform the staff on the policies and standards, conducting internal inspections and information drives, and keeping abreast with the latest rules and regulations. Moreover, a regulatory affairs manager is in charge of processing and submitting necessary documents to government agencies, ensuring compliance and timeliness.

Regulatory affairs associate vs regulatory affairs manager salary

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

	Regulatory Affairs Associate	Regulatory Affairs Manager
Average salary	$71,154	$117,714
Salary range	Between $49,000 And $102,000	Between $78,000 And $177,000
Highest paying City	San Rafael, CA	San Rafael, CA
Highest paying state	California	Vermont
Best paying company	Meta	McKinsey & Company Inc
Best paying industry	-	-

Differences between regulatory affairs associate and regulatory affairs manager education

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

	Regulatory Affairs Associate	Regulatory Affairs Manager
Most common degree	Bachelor's Degree, 69%	Bachelor's Degree, 64%
Most common major	Pharmacy	Business
Most common college	University of Southern California	University of Southern California

Regulatory affairs associate vs regulatory affairs manager demographics

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

	Regulatory Affairs Associate	Regulatory Affairs Manager
Average age	46	47
Gender ratio	Male, 30.5% Female, 69.5%	Male, 45.8% Female, 54.2%
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, 7.7% Unknown, 4.7% Hispanic or Latino, 12.8% Asian, 9.0% White, 65.1% American Indian and Alaska Native, 0.7%
LGBT Percentage	12%	10%

Differences between regulatory affairs associate and regulatory affairs manager 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.

Regulatory affairs manager example responsibilities.

Implement and achieve ISO 9001 and ISO 13485 registrations for the first time for the company.
Manage team which monitor the clinics' daily, weekly and monthly water and equipment maintenance requirements to meet CMS regulations.
Manage departmental and special project economics, including oversight of budgeting, expense management, and reimbursement billing.
Coordinate, oversee and audit record-keeping requirements of DEA, OSHA, D.O.T.
Conduct a comprehensive risk assessment of health plan with results from CMS audit as benchmark.
Perform all AML functions on new and existing customers, including OFAC checks and CIP.

Regulatory affairs associate vs regulatory affairs manager skills

Common regulatory affairs associate skills

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

Common regulatory affairs manager skills

Regulatory Affairs, 11%
FDA, 8%
Medical Devices, 6%
Regulatory Submissions, 5%
Regulatory Agencies, 5%
Global Regulatory, 5%

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Regulatory Affairs Associate
Regulatory Affairs Associate vs Regulatory Affairs Manager

Updated January 8, 2025

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