Regulatory Affairs Post Baccalaureate Certificate

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The Post Baccalaureate Certificate in Regulatory Affairs program prepares individuals to manage the regulatory process for companies innovating and developing cutting-edge products in science, biotechnology, pharmaceuticals, and medicine. Such programs includes instruction in regulatory affairs, clinical documentation, human and animal subject protection, Food and Drug Administration (FDA) regulations, data management and analysis, good manufacturing practices, and quality management.

Admissions Requirements

Completed application
3.0 GPA or higher
Bachelor’s degree (official transcripts)
Resume/CV
Essay
Two letters of recommendation
Healthcare experience preferred

Program Requirements

Grade Requirement: To receive a Post Baccalaureate Certificate in Regulatory Affairs, the student must complete all courses in the program with a grade of “C” or higher, and maintain an overall program GPA of 3.0 or higher.
Program Code: 2083GC
CIPC: 510702

Course Requirements

Required Courses

MHA 6000 - Health Systems & the Healthcare Economy Credits: (3)
MHA 6100 - Leading & Managing People in Healthcare Credits: (3)
MENG 6140 - Foundations of Professional and Technical Writing Credits: (3)
RGAF 6000 - Introduction to Regulatory Affairs Credits: (3)
RGAF 6100 - Biostatistics Applied to Research Credits: (3)
RGAF 6200 - Regulatory Drugs & Biologics Credits: (2)
RGAF 6230 - Regulatory Devices and Diagnostics Credits: (2)
RGAF 6250 - Regulatory Clinical Evidence Credits: (2)
RGAF 6300 - Compliance in Regulatory Affairs Credits: (3)

Elective Course

RGAF 6500 - Internship Credits: (3)