Regulatory affairs specialist vs regulatory affairs manager

The differences between regulatory affairs specialists 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 specialist and a regulatory affairs manager. Additionally, a regulatory affairs manager has an average salary of $117,714, which is higher than the $70,060 average annual salary of a regulatory affairs specialist.

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

Regulatory affairs specialist vs regulatory affairs manager overview

	Regulatory Affairs Specialist	Regulatory Affairs Manager
Yearly salary	$70,060	$117,714
Hourly rate	$33.68	$56.59
Growth rate	-	-
Number of jobs	9,915	12,569
Job satisfaction	-	-
Most common degree	Bachelor's Degree, 66%	Bachelor's Degree, 64%
Average age	46	47
Years of experience	4	4

What does a regulatory affairs specialist do?

A regulatory affairs specialist assists in securing and maintaining government approval for nutritional products, drugs, medical devices, and related supplies. They are often employed by medical, pharmaceutical, and biotechnology companies. They may also work in the government or law. Typically, they work on document preparation, file maintenance, information management, and coordination of tasks across various departments. They expanded their duties and responsibilities as a result of company acquisitions and restructuring, worldwide globalization of markets, and constantly evolving 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 specialist vs regulatory affairs manager salary

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

	Regulatory Affairs Specialist	Regulatory Affairs Manager
Average salary	$70,060	$117,714
Salary range	Between $49,000 And $99,000	Between $78,000 And $177,000
Highest paying City	Santa Rosa, CA	San Rafael, CA
Highest paying state	California	Vermont
Best paying company	Meta	McKinsey & Company Inc
Best paying industry	-	-

Differences between regulatory affairs specialist and regulatory affairs manager education

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

	Regulatory Affairs Specialist	Regulatory Affairs Manager
Most common degree	Bachelor's Degree, 66%	Bachelor's Degree, 64%
Most common major	Business	Business
Most common college	Stanford University	University of Southern California

Regulatory affairs specialist vs regulatory affairs manager demographics

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

	Regulatory Affairs Specialist	Regulatory Affairs Manager
Average age	46	47
Gender ratio	Male, 37.5% Female, 62.5%	Male, 45.8% Female, 54.2%
Race ratio	Black or African American, 10.7% Unknown, 4.5% Hispanic or Latino, 15.7% Asian, 8.2% White, 60.1% 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 specialist and regulatory affairs manager duties and responsibilities

Regulatory affairs specialist example responsibilities.

Gather, evaluating, organizing, managing and collating information in a variety of formats.
Manage CRO (regulatory) in support of the company's approve product in Europe.
Manage and submit electronic EPA product registrations.
Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
Support complaint handling process and screening, ensure FDA 21 CFR compliance.
Close complaints receive from external customers in compliance with FDA, ISO, QSR and other regulatory guidelines.

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 specialist vs regulatory affairs manager skills

Common regulatory affairs specialist skills

Regulatory Affairs, 10%
FDA, 8%
Regulatory Agencies, 7%
Medical Devices, 6%
Regulatory Compliance, 5%
Regulatory Submissions, 5%

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 Specialist
Regulatory Affairs Specialist vs Regulatory Affairs Manager

Updated January 8, 2025

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