Master of Science in Biotechnology: Biotechnology Regulatory Affairs

Professional Science Master'sThis program has been designated a Professional Science Master's Degree through the Council of Graduate Schools.

Biotechnology Regulatory Affairs Specialization

The biotechnology regulatory affairs specialization assists students with understanding the regulatory and policy issues that face the field of biotechnology. The curriculum covers the impact of regulatory and policy issues on domestic and international affairs, clinical trials and various aspects of a product's life cycle, good laboratory and manufacturing practices, quality control and assurance, bioethics, and the business of global biotechnology.

Career Path

The Master of Science program in biotechnology serves a number of careers at the entry-, mid-, or high-level positions, depending on the prior level of experience of the candidate.

Graduates of the biotechnology regulatory affairs specialization, depending on their background, can find positions such as:

  • Senior managers in regulatory affairs

  • Specialists in regulatory affairs

  • Quality assurance specialists

  • Clinical specialists

  • Other health care and biotechnology professionals

Master of Science in Biotechnology Course Requirements


  1. Students who wish to improve their graduate writing skills may take UCSP 605, Effective Graduate Writing (0).

Program Rules

  • BTMN 670 must be taken after completion of 30 credits of study.

  • Students without coursework in molecular biology must take BIOT 601 Introduction to Molecular Biology. BIOT 601 can be taken along with BIOT 640

Core Required Courses

UCSP 615* Orientation to Graduate Studies at UMUC (0), to be taken within the first 6 credits of study.

  • BIOT 640 Societal Issues in Biotechnology (3)

  • BIOT 630 Introduction to Bioinformatics (3)

  • BIOT 645 Bioprocessing and the Business of Biotechnology (3)

  • BIOT 643 Techniques of Biotechnology (3)

  • PMAN 634 Foundations of Project Management (3)

Core Rules

  1. BIOT 640 must be taken as the first program course.

  2. All core courses with the BIOT designator must be completed before starting any specialization.

Specialization - Biotechnology Regulatory Affairs (BTRA) Required Courses

  • BTMN 636 Biotechnology and the Regulatory Environment (3)

  • BTRA 640 Preclinical and Clinical Research Design (3)

  • BTRA 641 Product Life Cycle–Approval, Production, and Marketing for Devices and Drugs (3)

  • BTRA 642 Global Biotechnology Business Issues (3)

  • BTRA 643 Practical Applications of Biotech Regulatory Affairs (6)

Capstone Course

BTMN 670 Capstone in Biotechnology (3)
Note: BTMN 670 is not offered during the summer term.

* The UCSP 615 requirement may be waived if you previously earned a graduate degree from a regionally accredited institution. For more information, contact your academic advisor.

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Professional Science Master's Recognized in Washington Post

UMUC's Professional Science Master's degrees were recognized by the Washington Post for helping students pair scientific know-how with business savvy. Read the article to learn about how UMUC's capstone projects help our students stand out in the job market.

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Master of Science in Biotechnology

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