Strengthen your marketability in international biotech business with a master's degree in biotechnology with a specialization in biotechnology regulatory affairs.

Specializing in biotechnology regulatory affairs, you'll develop expertise in the life cycle of biotechnology products and learn how to help businesses and regulators work together for safety and quality. This rare program, one of only a few in the nation, will give you a unique credential to help you stand out from the crowd.

Your biotechnology regulatory affairs specialization could prepare you to help bring a new medical technology to market, bring a life-saving drug to a new country, manage a top-quality research laboratory, or work for a regulating agency to improve drug and device safety for millions of people. You'll build strong skill sets in molecular biology, business, and policy to make yourself an indispensable asset to the public and private sectors of the biotech industry.

These program requirements are for students who enroll in the 2019–2020 academic year. For prior year academic requirements, visit the catalog archive in the Current Students section.

About the Biotechnology Master's Degree with Biotechnology Regulatory Affairs Specialization

In your core courses, you'll study the science and techniques used in biotechnology as well as the industries surrounding them. In your regulatory affairs specialization courses, you'll learn how regulations and policies impact domestic and global biotech business, clinical trials, and product life cycles. The biotechnology regulatory affairs curriculum also covers laboratory and manufacturing best practices, quality control and assurance, and bioethics.

What You'll Learn

Through your coursework, you will learn how to

  • Develop a management plan for a clinical trial
  • Assemble packages for an investigational new drug, a new drug application, a new device exemption, or a Biological License Application
  • Demonstrate your knowledge of Federal Drug Administration regulations, including Title 21
  • Navigate the policies and procedures for gaining marketing approval for a medical product within the United States, European Union, Japan, Canada, Brazil, India, or China
  • Comprehend the economics of bioprocessing, regulatory affairs, and global business models used in biotechnology
  • Implement advanced project management skills to lead a successful team

Coursework Examples

In past projects, students have had the opportunity to

  • Complete a group project simulating the development of a drug or device through the product life cycle
  • Generate a management plan and outline a funding proposal for a clinical trial
  • Write a review of a 510(k) submission for a medical device from the point of view of an FDA reviewer
  • Assemble several types of applications for marketing approval using real-world data sets
  • Work on a team for a sponsoring agency or organization to tackle a real biotechnology project to fit that organization's needs

Industry Certification

This program can help prepare you for the following certification exam(s):

Biotechnology Master's Degree with Biotechnology Regulatory Affairs Specialization Requirements

Our curriculum is designed with input from employers, industry experts, and scholars. You'll learn theories combined with real-world applications and practical skills you can apply on the job right away.

Master's - specialization Courses

Introductory Course

  • UCSP 615
    (to be taken within the first 6 credits of study)

Core Courses

  • BIOT 640
  • BIOT 630
  • BIOT 645
  • BIOT 643
  • PMAN 634

Core Rules & Recommendations

  • BIOT 640 must be taken as the first course.
  • All BIOT courses must be completed in the order listed before taking specialization courses.
  • If you need to take BIOT 601, you can take it at the same time as BIOT 640.

Specialization Courses

  • BTMN 636
  • BTRA 640
  • BTRA 641
  • BTRA 642
  • BTRA 643

Capstone Course

  • BIOT 670

Capstone Rules & Recommendations

  • This course must be taken after you have completed 30 credits.
  • Please check the Schedule of Classes to confirm course availability.
  • Currently, BIOT 670 is not available during the summer term.

Other Requirements

  • You must maintain a GPA of 3.0 or higher at all times.
  • All degree requirements must be fulfilled within five consecutive years.
  • Any transfer credits must have been earned within the five-year time frame to be applied toward a graduate degree.

Career Preparation

This program is designed to help prepare you for preclinical and clinical trial management, data interpretation, product safety work, and work with regulatory agencies. Potential employers include corporate organizations and government agencies.

Experience Recommended for Success in the Program

If you would like to improve your graduate writing skills, you should take UCSP 605.

Program Admission Requirements

A molecular biology background is required for progression within this program. Upon submission of an official transcript, you can be accepted into the degree program without a molecular biology background, but must either take a college-level molecular biology course or BIOT 601 prior to the required program core.

Special Designations

PSM LogoThis program has received a special designation as a Professional Science Master's Degree by the Council of Graduate Schools.