Regulatory affairs manager vs regulatory affairs director

The differences between regulatory affairs managers and regulatory affairs directors 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 manager and a regulatory affairs director. Additionally, a regulatory affairs director has an average salary of $122,617, which is higher than the $117,714 average annual salary of a regulatory affairs manager.

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

Regulatory affairs manager vs regulatory affairs director overview

	Regulatory Affairs Manager	Regulatory Affairs Director
Yearly salary	$117,714	$122,617
Hourly rate	$56.59	$58.95
Growth rate	-	-
Number of jobs	12,569	13,981
Job satisfaction	-	-
Most common degree	Bachelor's Degree, 64%	Bachelor's Degree, 67%
Average age	47	47
Years of experience	4	4

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.

What does a regulatory affairs director do?

A regulatory affairs director's role is to spearhead the efforts to ensure that all company operations adhere to industry standards and government regulations. Their responsibilities include coordinating with different departments to gather and analyze data, evaluating compliance in various areas, preparing and processing documentation, liaising with external parties, and devising strategies to optimize company compliance. Furthermore, as a regulatory affairs director, it is essential to maintain an active communication line with the workforce, all while implementing the company's policies and regulations.

Regulatory affairs manager vs regulatory affairs director salary

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

	Regulatory Affairs Manager	Regulatory Affairs Director
Average salary	$117,714	$122,617
Salary range	Between $78,000 And $177,000	Between $81,000 And $184,000
Highest paying City	San Rafael, CA	Sacramento, CA
Highest paying state	Vermont	Massachusetts
Best paying company	McKinsey & Company Inc	Coty
Best paying industry	-	Pharmaceutical

Differences between regulatory affairs manager and regulatory affairs director education

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

	Regulatory Affairs Manager	Regulatory Affairs Director
Most common degree	Bachelor's Degree, 64%	Bachelor's Degree, 67%
Most common major	Business	Business
Most common college	University of Southern California	Stanford University

Regulatory affairs manager vs regulatory affairs director demographics

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

	Regulatory Affairs Manager	Regulatory Affairs Director
Average age	47	47
Gender ratio	Male, 45.8% Female, 54.2%	Male, 55.8% Female, 44.2%
Race ratio	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%	Black or African American, 7.5% Unknown, 4.7% Hispanic or Latino, 12.6% Asian, 8.7% White, 65.9% American Indian and Alaska Native, 0.7%
LGBT Percentage	10%	10%

Differences between regulatory affairs manager and regulatory affairs director duties and responsibilities

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 director example responsibilities.

Implement ISO 9001complaint quality system and manage surveillance audits.
Assess state Medicaid manage care contract and vendor contract requirements to create compliance audit plans.
Manage customer complaints, including MDR submissions, maintenance of complaint database, and correspondence with the customer.
Provide subject matter expertise involving applicable FDA regulations, EU directives, ISO and ASTM standards, and applicable ICH guidelines.
Secure timely approvals for company products (IDE, PMA, Import/Export, ISO).
Prep stability reports for international markets in accordance with FDA and ICH guidelines.

Regulatory affairs manager vs regulatory affairs director skills

Common regulatory affairs manager skills

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

Common regulatory affairs director skills

Regulatory Affairs, 13%
FDA, 8%
Regulatory Strategy, 7%
Global Regulatory, 7%
Regulatory Agencies, 7%
Regulatory Submissions, 4%

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Regulatory Affairs Manager
Regulatory Affairs Manager vs Regulatory Affairs Director

Updated January 8, 2025

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