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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 within the award-winning University of Maryland University College Master of Science in biotechnology program, 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.

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 datasets
  • Work on a team for a sponsoring agency or organization to tackle a real biotechnology project to fit that organization's needs
  • Work with industry mentors from organizations such as Pacific Medical Bridge, EMD Serono, and Medimmune

Industry Certification

This program can help prepare you for the following certification exams

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)

We also recommend UCSP 605 if you'd like to improve your graduate writing skills.

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 don't have a molecular biology background, you must take a college-level molecular biology course or BIOT 601 prior to the required program core. BIOT 601 can be taken in your first semester along with BIOT 640.

Specialization Courses

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

Capstone Course

  • BTMN 670

Capstone Rules & Recommendations

  • This course must be taken after you have completed 30 credits.
  • This course is not offered 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.
 

Program Admission Requirements

If you don't have a molecular biology background, you must either take a college-level molecular biology course or BIOT 601 prior to the required program core. BIOT 601 can be taken in your first semester along with BIOT 640.

Quality Assurance Recognition

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