What is Regulatory Science?
Regulatory science is the science of public health assurance regarding rules, standards, and products that the Food and Drug Administration (FDA) regulates. The FDA regulates drugs, food, vaccines, medical devices, tobacco, and cosmetics to protect public health. Regulatory science monitors and develops standards and approaches that affect the safety, quality, and efficacy of all FDA regulated products.
Regulatory science is the application of both art and science that takes a product from conceptual design through marketing and product launch while honoring all the laws and requirements.
What is a Regulatory Science Degree?
Regulatory science has several levels and types of degrees within its wide-encompassing subject matter. Each step in biomedical product manufacturing is regulated. There are many stages in the process of biomedical product manufacturing, and regulations apply at every level. Regulatory scientists work at every stage of product development.
Regulatory science includes the following:
- Regulatory affairs
- Regulatory writing
- Risk management
- Regulatory Law
Regulatory scientists evaluate products, product candidates, and clinical trials. It takes years to get a product from conception to market, and the field requires expertise from scientists of all disciplines. Regulatory scientists include physicists, life scientists, chemists, and engineers. In the 1980's and 1990's most individuals working in regulatory science learned on the job. Being that is is such a lengthy and time-consuming endeavor to get a product FDA-approved, there was a push for more structured and standardized education in regulatory science. The drive for more extensive formalized training in regulatory science resulted in over 30 United States universities offering Master's degrees, Ph.D.'s or certificates in the field.
These degrees prepare graduates to navigate complex regulations and bring innovative medical ideas to market.
What are the Regulatory Science Degree Options?
Regulatory Science degrees are relatively new and are the result of the strong need for more standardized protocols for product and medication development. Thirty years ago, regulatory scientist "learned on the job" but that is changing. The demand for qualified professionals is critical to our rapidly expanding and evolving healthcare environment. Doctoral degree programs in regulatory science are not as frequent as the Master's degree, but the Ph.D. in Regulatory Affairs is growing in demand and popularity.
- PhD. in Regulatory Affairs - coursework includes risk management, clinical trial design, FDA submissions, and laws.
- Certificate - A certificate program is 18 credits or less completed in 2-4 semesters for healthcare professionals entering the field or wishing to increase their knowledge and skills.
- Master Degree in Regulatory Science - This program focuses mainly on drugs and biologics which prepares the student for working in medical research and pharmaceutical industry.
- Master of Professional Studies in Regulatory Affairs - This degree focuses on the ethics, science, policies, and business of product safety starting with pre-clinical trials through market launch.
What Type of Courses Will I Take?
Students take a variety of mandatory and elective courses. Students that have industry experience may choose to take electives instead of an internship. Students with no background participate in placements in various fields.
- Introductory and Advanced Regulation
- Quality Assurance
- Clinical Research
- Medical Product Law
How Long is the Program?
A certificate in regulatory science can take as little as 2-4 semesters, and this is the entry point for standardized education in regulatory science. Most graduate programs offered online and brick and mortar schools have a minimum of 36 graduate credits and an internship.
Masters in Regulatory Science Entry Level Salary
According to Payscale, the starting salary for this degree is $57,437 and can increase to $108,329 and upwards depending on years of experience.
Masters in Regulatory Science Career Options
Regulatory science as a discipline has an integral role in the world's health, food safety, and medical innovations. It's a growing job market with an increasing demand for specialized regulatory expertise. There is much flexibility in work environments as a regulatory science graduate can work about anywhere in the regulated industry of medicine.
- Medical device technology
- Food Science
- Academic Institutions
- Government Agencies
- Policy Making
What is a Masters in Regulatory Affairs and Quality Assurance Degree?
A Masters in Regulatory Affairs and Quality Assurance (RAQA) prepares students to work in pharmaceuticals and related industries. The specialized curriculum blends regulatory science classes with quality practices.
Masters in Regulatory Affairs Salary and Career Option
According to Salary.com, the median annual salary for an entry level Regulatory Affairs Specialist is $57,758. Most individuals with Master's In Regulatory Affairs and Quality Assurance work in the pharmaceutical industry.