This article will explain why you would want to earn a master’s degree in regulatory affairs, and also the different types of career options that are open to you with this degree. Also, we have researched some of the best online universities where you can earn your master’s degree.
With a need to both innovate in the 21st century and to safeguard the public health, it is important to bring new medical products to market while making sure that they are safe and effective.
That is why regulatory affairs professionals are in very high demand throughout the US. There also is more demand for these products that regulatory professionals work on because people across the US live much longer than they did even 50 years ago.
The entire field of regulatory affairs is actually a new area which has been developed over the last few decades as the federal and state governments want to control the safety of products in these areas:
- Pharmaceuticals
- Veterinary medicines
- Medical devices
- Agrochemicals
- Cosmetics
- Complementary medicines
The job of the regulatory professional is to ensure that companies are keeping up with product manufacture and distribution standards in all areas where the company is making or distributing its products. If the company does not do so, they can face very serious sanctions from domestic and international regulatory bodies. This can make it very expensive for them to continue to produce their medical device and pharmaceutical products.
RAs also may advise on legal and scientific issues regarding how products are being made. They also are responsible for presenting all registration documents to various regulatory agencies, which can include FDA, EPA and OSHA among others.
RAs also provide strategic and technical advice to corporate executives in their companies. They usually do so right from the start of product development. Therefore, RAs make very important contributions to the commercial and scientific success of many types of products that help people in many fields.
Another very important aspect of an RA’s job duties is to follow the development of a product through the years of its development and eventual launch. For example, it can take 10 years for a new pharmaceutical product to be developed and launched.
Many scientific issues can occur during development, and new regulations may be added. RAs assist the company with avoiding regulatory problems by ensuring that accurate records are being kept and that they are following all new regulations.
If you are interested in being in regulatory affairs, you will need to have a very strong base in the sciences and also be well educated on legal and regulatory matters in the field in which you are interested.
While you can earn a master’s degree in regulatory affairs that will largely prepare you for this job, many successful regulatory affairs professionals have years of experience in the field and then eventually earn their master’s degree. For example, a quality assurance professional in a drug company may work in pharmaceuticals for several years and eventually decide to earn her master’s degree in regulatory affairs.
According to the Bureau of Labor Statistics, the mean salary for compliance officers in the US is $69,000, with the states of California, Texas and New York employing the most compliance and regulatory professionals.
If you are interested in regulatory affairs as a career, you may want to consider the following degree programs:
Master of Regulatory Affairs
An excellent Master of Regulatory Affairs program is available through George Washington University, with its Master of Science in Health Sciences in Regulatory Affairs. This program has been developed by working closely with RA professionals who work at FDA and NIH, among several others.
This master’s program features the incorporation of regulatory strategy on a global level across its curriculum. It will develop you as a strategic business leader and will provide you with the critical skills that you need to succeed in regulatory affairs around the country and world. Skills that you will learn here include:
- How to apply financial principles to strategic business decision making
- How to develop leadership skills in managing change in an organization
- Developing professional communication skills and also learn how to negotiate
- Apply a cohesive regulatory affairs strategy to streamline business objectives
This online MHHS in regulatory affairs will prepare you to meet the strong need for skilled RA professionals and to lead the successful delivery of new healthcare products. Graduates of this program typically go on to work in these occupations:
- Regulatory affairs specialist
- CMC manager
- Compliance officer
- Technical engineer
- Quality control administrator or manager
GW offers two different RA programs online. One of them is the full master’s program, and the other is a Graduate Certificate program, which consists of 18 credit hours. The certificate program is a popular option for current working professionals in regulatory affairs. You later can apply those credits towards the full master’s program.
Master of Regulatory Affairs – Drugs, Biologics and Medical Devices
For people who want to work specifically in drugs, biologics or medical devices, you should consider this master’s degree from Northeastern University. This is a unique, online master’s degree that will greatly enhance your grasp of current FDA regulations and how they are applied to developing and commercializing drugs, biologics and devices.
The program’s regulatory affairs courses will offer you the knowledge and perspective that you need to manage the regulatory process effectively in your organization.
Required curriculum includes these courses:
- Introduction to Drug and Medical Device Regulation
- New Drug Development: A Regulatory Overview
- Medical Device Development
- Food, Drug and Medical Device Law
- Regulatory Writing for Medical Device Submissions
- Regulatory Writing for New Drug Applications
- Regulatory Documentation Processes
- Introduction to Safety Sciences
Most of the students in this program are in research and development, clinical studies and trials, premarket approvals, manufacturing, labeling and post market surveillance.
Master of Regulatory Affairs and Quality Assurance
Temple University was the very first to launch a graduate education program in regulatory affairs and quality assurance for the drug industry in 1965. Temple’s School of Pharmacy has long been the gold standard for regulatory professional education in the pharmaceutical field.
Today, Temple University offers an online master’s program for regulatory professionals who want to expand their career options in the pharmaceutical field.
This is a two year online program but also offers live interaction opportunities with instructors and students. This program also offers a certificate that you can earn in a regular classroom environment on campus. If you currently work at a pharmaceutical company and want to participate in either program, some of the classes can be video conferenced into your workplace.
Your classes include:
- Drug Development
- Food and Drug Law
- Good Manufacturing Practices
- Good Clinical Practices
- Advanced GMPs
- IND and NDA Submissions
- Process Validation
- High Purity Water Systems
- Regulatory E-Submissions
- Generic Drug Regulation
- Biotechnology
- Conducting Quality Audits
The bottom line on regulatory affairs is that there will always be good job demand for the higher educated regulatory professionals, especially today as more medical products are being developed. People live longer and live more active lives. They want to have access to better drugs, devices and biologic products that help them to live a more productive life.
