Regulatory Affairs Graduate College Credit Certificate


Innovation is rife in today's world, but there is a long path from concept to implementation.

Nearly every phase in the drug and medical devices’ lifecycle starting from R&D moving forward through clinical research to marketing is governed by regulations.

The development of new drugs, biologics, and medical devices is a long, complex, and expensive process. It is estimated that the development of a new drug can take up to 15 years and cost up to $2 billion dollars. So, the pharmaceutical industry is always under enormous pressure to reduce the time and cost to bring these products to the market.

The success of a pharmaceutical company depends increasingly on experts with experience in regulatory processes due to continuous updates in legislation, policies, as well as technologies.

When one considers the vast number of products regulated by the regulatory authorities, it is clear why professionals with expertise in Regulatory Affairs have perhaps never been more important.

You can work with a government organization to protect patients’ safety or assist companies in bringing compliant medical products to market—there are many options in the field of Regulatory Affairs.

What is Regulatory Affairs?

The science responsible for applying the standards and regulations that assess the safety, efficacy, quality, and performance of the regulated medical products in order to get regulatory authorities’ approvals. Regulatory affairs is the link and the “go-between” the pharmaceutical or medical device company AND the regulatory authority that regulate them like the U.S. Food and Drug Administration, European Medicines Agency, or any equivalent authority. The biomedical industry needs regulatory affairs specialists to help engineers and scientists meet the regulatory authorities’ standards as they develop new drugs, medical devices, and biologics.

What Do Regulatory Affairs Specialists Do?


What are the Job Positions for the Regulatory Affairs Professional?

As of 2018, 73% of regulatory professionals are employed by a mix of academic institutions, clinical research organizations, regulatory authorities, or pharmaceuticals, medical devices, dietary supplements, and cosmetics industry.

Along with the promise of job security, pursuing a career in Regulatory Affairs affords a great deal of flexibility in where to choose to work. With so many options, regulatory affairs professionals can choose to work in organizations of any size, ranging from 10 to 10,000 employees in any of these departments and much more:

  • Quality Control
  • Clinical Research
  • Regulatory Affairs
  • Compliance
  • Pharmacovigilance

Joining the Regulatory Affairs role is absolutely an option if you want to increase your salary or secure you a promotion. What Are the Expected Salaries for Regulatory Affairs Professionals?

Much like the setting and scope of a regulatory job, regulatory salaries vary, depending on job function, previous regulatory experience, seniority, geographic market, and highest earned degree. As market demand has increased, employers are willing to pay more for the right level of skill.

Since 1995, salaries across all Regulatory Affairs professionals have maintained a general upward trend, increasing by an average of 3.3% per year. 2016, the average yearly salary for regulatory professionals at all levels was $150,422.

In 2018, the Regulatory Affairs Professional Society (RAPS) reported that the national average total compensation for U.S.-based regulatory professionals by job level is:

  • Vice President: $256,500
  • Director: $189,000
  • Manager: $139,000
  • Project Manager: $128,000
  • Specialist: $123,000
  • Associate: $93,000

If you have a postgraduate degree, your salary may substantially double depending on the industry you choose. Just remember that some fields will pay off more than others.

Also, If you’re looking to secure a promotion, the RADEX Institute graduate certificate can help you gain the knowledge and skills required to move up the ladder at your current company. Most companies prefer a postgraduate degree to grant a promotion to management positions.