regulatory-affairs-specialist
How to Become a

Regulatory Affairs Specialist

The complete career guide to be a Regulatory Affairs Specialist: salary, job growth, employers, best schools, and education you may need to get started.

Why We Love It

  • $69,180
    Potential Avg. Salary
  • 3.3%
    Job Growth Rate
  • Growing Demand
    Job Outlook
  • Growing Industry
    Career Attribute

Regulatory affairs specialists bridge the gap between a company, its services or products, and governmental agencies who regulate the company’s industry. They use their familiarity with the government regulations that affect an industry to ensure business operations are compliant.

Recommended Schools


What is a Regulatory Affairs Specialist?

The following job responsibilities are common for individuals in regulatory affairs specialist roles:

  • Fully understand all laws and regulations that are applicable to an industry
  • Review products, processes, and procedures within a company to determine whether or not the company is in compliance with government regulations
  • Recommend alternative procedures when non-compliance is discovered
  • Conduct incremental, ongoing reviews of products, processes, and procedures to ensure continued compliance
  • Write reports on findings and present to company leadership

A Day in the Life

Essentially, a regulatory affairs specialist is a role that bridges the gap between a company, its services or products, and governmental agencies who regulate the company’s industry. Most commonly, this position is found in medical settings (including pharmaceutical companies), but many other industries have also begun to use the particular talents of skilled regulatory affairs specialists. Energy, telecommunications, cosmetics, and banking are a few examples of other industries where this position is found.

Because a regulatory affairs specialist can work in diverse industries, their day-to-day tasks can be quite different. However, nearly all industries will follow a similar arc of research, analysis, and drafting reports. As a start, the regulatory affairs specialist will review and become familiar with existing industry regulations and determine whether the employer is in compliance or not. From there, a detailed report or action plan can be developed to assist the company in meeting the regulation requirements.

In addition to ensuring compliance for company goods or services, a regulatory affairs specialist is often tasked with analyzing a new procedure or product during the development stage. With a solid working knowledge of industry regulations, a regulatory affairs specialist may also be asked to judge the regulatory climate and be able to predict upcoming changes to regulations. These tasks are especially useful in the pharmaceutical and medical industries.

Typical Work Schedule

Regulatory affairs specialist toles are usually full-time positions conducted during normal business hours. Individuals in these positions typically enjoy evenings, weekends, and major holidays off of work.

Projected Job Growth

In recent years, government regulations of different industries have increased exponentially, and these new and more complex regulations are expected to significantly increase the demand for regulatory affairs specialists in the coming decade.

Typical Employers

Regulatory affairs specialists are employed by large businesses and corporation across a variety of industries. Healthcare industries—including pharmaceuticals, providers, and health insurance companies—are some of the top employers of regulatory affairs specialists. Banking and finance industries also commonly keep regulatory affairs specialists on staff.

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How To Become a Regulatory Affairs Specialist

The requirements of a regulatory affairs specialist will largely depend on the industry involved, but the vast majority will require a bachelor’s degree as a minimum, and most successful candidates will also have a master’s degree. For the most common positions in the pharmaceutical and medical fields, these degrees will often need to be in a scientific field to form a solid knowledge base from which to understand the issues and regulations at hand.

Because of the extensive knowledge needed, few regulatory affairs specialists are hired as an entry-level position. The most common way to obtain a position is through experience and promotion from within a company. As such, internships, residencies, and other programs are excellent ways for a prospective regulatory affairs specialist to gain the experience needed to be employed in this career. Also, switching positions between industries is extremely difficult due to the field-specific knowledge.

While having a good theoretical knowledge base and experience working in an industry will prepare a person for a career as a regulatory affairs specialist, there are also certain skills that will help you excel once you have this job. With reports that can be hundreds or even thousands of pages long and serious consequences for not complying with regulations, being detail-oriented and meticulous should be one of your strongest qualities if you want to be a regulatory affairs specialist.


Regulatory Affairs Specialist Salary Data

We’ve provided you the following to learn more about this career. The salary and growth data on this page comes from recently published Bureau of Labor Statistics data while the recommendations and editorial content are based on our research.

National Anual Salary

Low Range

$48,810

Average

$69,180

High Range

$102,940

National Hourly Wage

Low Range

$23/hr

Average

$33/hr

High Range

$49/hr

How do Regulatory Affairs Specialist salaries stack up to other jobs across the country? Based on the latest jobs data nationwide, Regulatory Affairs Specialist's can make an average annual salary of $69,180, or $33 per hour. On the lower end, they can make $48,810 or $23 per hour, perhaps when just starting out or based on the state you live in.

Salary Rankings And Facts

  • #204 Nationally for All Careers

  • Above Average Salary Nationally


Programs and Degrees

Here are the most common degrees for becoming a Regulatory Affairs Specialist. a is usually recommended and specifically a degree or coursework that prepares you for the particular field, see below.


Highest Education Among Regulatory Affairs Specialists

  • 5.4%   Doctorate
  • 15.9%   Masters
  • 39.4%   Bachelors
  • 9.9%   Associates
  • 18.4%   College
  • 9.8%   High School
  • 1.1%   Less than High School

Job Growth Projections and Forecast

2014 Total Jobs

260,300

2024 Est. Jobs

269,000

Job Growth Rate

3.3%

Est. New Jobs

8,700

How does Regulatory Affairs Specialist job growth stack up to other jobs across the country? By 2024, there will be a change of 8,700 jobs for a total of 269,000 people employed in the career nationwide. This is a 3.3% change in growth over the next ten years, giving the career a growth rate nationwide of Above Average.

Growth Rankings And Facts

  • #507 Nationally for All Careers

  • Above Avg. Growth Nationally


What Companies Employ The Most Regulatory Affairs Specialists

Industry Current Jobs New Jobs Needed % Increase
Federal government, excluding postal service 57,100 -5,500 -6%
State government, excluding education and hospitals 35,500 600 1%
Local government, excluding education and hospitals 28,900 1,600 2%

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