Regulatory affairs director vs regulatory affairs specialist

The differences between regulatory affairs directors and regulatory affairs specialists 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 director and a regulatory affairs specialist. Additionally, a regulatory affairs director has an average salary of $122,617, which is higher than the $70,060 average annual salary of a regulatory affairs specialist.

The top three skills for a regulatory affairs director include regulatory affairs, FDA and regulatory strategy. The most important skills for a regulatory affairs specialist are regulatory affairs, FDA, and regulatory agencies.

Regulatory affairs director vs regulatory affairs specialist overview

	Regulatory Affairs Director	Regulatory Affairs Specialist
Yearly salary	$122,617	$70,060
Hourly rate	$58.95	$33.68
Growth rate	-	-
Number of jobs	13,981	9,915
Job satisfaction	-	-
Most common degree	Bachelor's Degree, 67%	Bachelor's Degree, 66%
Average age	47	46
Years of experience	4	4

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.

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.

Regulatory affairs director vs regulatory affairs specialist salary

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

	Regulatory Affairs Director	Regulatory Affairs Specialist
Average salary	$122,617	$70,060
Salary range	Between $81,000 And $184,000	Between $49,000 And $99,000
Highest paying City	Sacramento, CA	Santa Rosa, CA
Highest paying state	Massachusetts	California
Best paying company	Coty	Meta
Best paying industry	Pharmaceutical	-

Differences between regulatory affairs director and regulatory affairs specialist education

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

	Regulatory Affairs Director	Regulatory Affairs Specialist
Most common degree	Bachelor's Degree, 67%	Bachelor's Degree, 66%
Most common major	Business	Business
Most common college	Stanford University	Stanford University

Regulatory affairs director vs regulatory affairs specialist demographics

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

	Regulatory Affairs Director	Regulatory Affairs Specialist
Average age	47	46
Gender ratio	Male, 55.8% Female, 44.2%	Male, 37.5% Female, 62.5%
Race ratio	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%	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%
LGBT Percentage	10%	12%

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

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 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 director vs regulatory affairs specialist skills

Common regulatory affairs director skills

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

Common regulatory affairs specialist skills

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

Regulatory Affairs Director vs. similar jobs

Regulatory Affairs Director related careers

Regulatory Affairs Director related jobs

What similar roles do

Zippia Careers
Executive Management Industry
Regulatory Affairs Director
Regulatory Affairs Director vs Regulatory Affairs Specialist

Updated January 8, 2025

Browse executive management jobs