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Best Online Master’s Degrees in: Regulatory Affairs

Explore a Master’s Degree in Regulatory Affairs

Regulatory affairs is the practice of ensuring that an organization’s operations comply with regulations and laws set by the government. An online master’s degree in regulatory affairs is a sound option for students or regulatory affairs professionals who want to advance their careers. A master’s degree in regulatory affairs gives students the knowledge and skills needed to help companies cooperate with increasingly complex government regulations. This degree may take the completion of at least 40 credit hours to complete, although the length of the program may vary by college or university.

Class Curriculum

A regulatory affairs graduate degree program is designed to deepen a student’s understanding of the relationship between current regulations and the development of drugs, biologics, and medical devices. Therefore, students may enroll in courses such as drug and medical device regulation, new drug development, medical device development, and food, drug, and medical device law. Depending on the college or university, students may also be required to take business, law, or development and marketing courses. Read on for a closer look at three regulatory affairs courses:

  • Drug and Medical Device Regulation. The drug and medical device regulation course covers the relationship between the development of drugs, biologics, and devices and the Food and Drug Administration (FDA). The class looks at the development of drug laws over time, the function of the FDA, policy-guided science, and cases that affect regulation today.
  • New Drug Development. This course educates students on each step of the drug development and regulation process, from preclinical testing through adverse experience reporting. It also examines the FDA standards for quality assurance, good laboratory practice, investigational new drug application, and the review process initiatives designed to speed drug review.
  • Food, Drug, and Medical Device Law. This course examines current food, drug, and medical device laws and landmark court cases. It also covers laws concerning the development, manufacture, and commercial distribution of drugs, biologics, and medical devices.

Students of a regulatory affairs master’s degree program are typically required to complete reading assignments from academic textbooks or articles provided by the instructor, quizzes, exams, and research papers. They may also need to participate in class discussions on various topics, with their grade determined by their ability to meaningfully contribute to the discourse instead of reciting the course material.

Building a Career

A master’s degree in regulatory affairs may qualify an individual to work as a regulatory affairs specialist, manager, or director at a medical or pharmaceutical company. Regulatory affairs specialists are responsible for handling all government interactions for products requiring government approval. They also help ensure regulatory compliance. Meanwhile, regulatory affairs managers supervise the regulation process required for governmental approval, and directors manage the entire process and reports to top management. More than 40% of regulatory affairs directors have master’s degrees and at least 15 years of experience, according to Salary.com.

An entry-level regulatory affairs specialist earns a median annual salary of $53,276, while a specialist with eight years of experience earns a median salary of $101,863, according to Salary.com. Meanwhile, a regulatory affairs manager earns a median salary of $102,875, and a director makes $148,950. However, keep in mind the salary statistics are no guarantee of actual pay, which is determined by employer, location, and the condition of the economy.

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