Program Overview

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Program Overview

The Certificate in Regulatory Affairs is an online, part-time 6-credit program for working professionals. The certificate aims to provide participants with regulatory affairs experience for all FDA-regulated product classes (drugs, biologics, and devices).

Why Choose Keck Graduate Institute?

Keck Graduate Institute offers breakthrough approaches to education in healthcare, biotech, and applied life sciences. Our courses are taught by experts with real-world professional experience with some of the top names across healthcare and science organizations and companies.

Who Should Apply

Life science professionals with applied life science experience with an interest in gaining knowledge of regulatory affairs as it relates to the bioscience and healthcare industries.

What You'll Gain

Participants will participate in online interactive courses that focus on the regulatory challenges that applied life science companies face today and be able to present requirements to industry management and regulatory site personnel, including documentation, and accepted industry practices. Topics and skills include:

• Understand regulatory background, principles, and best practices in developing and managing regulatory systems within the biopharmaceutical industry.
• Comprehend and assess the documentation and regulatory requirements necessary at each stage of the regulatory submission and review process.
• Present requirements to industry management and regulatory site personnel, including documentation, and accepted industry practices.
• Present requirements to industry management and regulatory site personnel, including documentation, and accepted industry practices.
• Extended understanding of the language, logic, and critical thinking skills, to make regulatory decisions and develop strategies regarding product development and submissions.
• Be conversant in drug and biologic product development and licensure, including product development cycle, testing and labeling criteria, treatment regimen, adverse event assessment, documentation, efficacy response assessment, pre- and post-approval documentation requirements.

Program Course Overview

The Certificate is composed of 4 courses for a total of 6 credits and can be started in the Fall or Spring.

Fall Term

• REG 5000 Introduction to US Food and Drug Law (1.5 credits)
• REG 6110 Drug and Biologics Regulations (1.5 credits)
• REG 6120 Medical Device Regulations (1.5 credits – REG 5000 pre-requisite)

Spring Term

• REG 5000 Introduction to US Food and Drug Law (1.5 credits)
• International Regulations (1.5 credits – REG 5000 pre-requisite)

Program Requirements

Eligibility

• Earned bachelor degree by the start of the program (science major recommended)
• Work experience in applied life science or additional education

Admission Requirements

• Application – An online application form is required that contains questions about your personal and educational background.
• Transcripts – Unofficial transcripts verifying a bachelor degree may be submitted for evaluation purposes. If admitted and you choose to complete the certificate, official transcripts will be required. Translated copies must be submitted for international students.
• CV or Resume – To verify work experience or additional education.

Application Review

The Admissions Committee is made up of faculty and senior administrators who will thoroughly and conscientiously review each application. Applications will be considered in the context of the total applicant pool, as well as in relationship to our general admissions standards. We do not use arbitrary grade point or test score cutoffs.

All admissions decisions are final for the academic year in which they are rendered.

Program Details

Format

Online Asynchronous with Synchronous Components

Next Start Date

August 2025

Duration

9 Months

Cost

$1,070 per credit
Degree total 6 credits $6,420