Animal Health Regulatory Affairs Graduate Certificate

Confidently manage multimillion dollar animal health products as you navigate federal agencies, compliance laws and communications across internal and external units throughout product development to market release and beyond.

Certificate Overview

Learn a bit about this program and how to apply.

Regulatory affairs is a critical component of the growing animal health industry. The 15 credit hour Regulatory Affairs graduate certificate is based on industry input and exclusively tailored to the animal health industry. It provides a series of courses and experiences that will help equip animal health professionals with the tools and knowledge needed to navigate governmental processes and regulations.

$8,500 total

15 credit hours

Earn with your degree

*The total for this 15 credit hour certificate program is approximately $8,500.

Admissions Requirements

Official transcripts for all undergraduate coursework (minimum 3.0 GPA required)
Official transcripts for all graduate coursework
A completed application to the K-State Graduate School. This application has a $50 fee. Attend a webinar or info session and receive a code to waive this application fee.

Educational/Background Requirements

Regulatory affairs professionals have varied backgrounds, with many trained in the biosciences, manufacturing or technical writing. This graduate certificate is for professionals with a bachelor's degree in a variety of fields.

This Animal Health Regulatory Affairs Graduate Certificate is ideal for working professionals who want to:

Demonstrate comprehensive understanding of the regulatory process and strategy for products approved by the FDA/EPA/USDA.
Identify the extent to which clinical research protocols establish the efficacy and safety of products compliant with regulatory guidelines for product development.
Synthesize regulatory requirements with effective business practices while operating in a compliant manner.

Careers

Program Features

No required prerequisites
16 week courses, available after business hours
Full-time faculty and guest lecturers with industry experience
May start coursework any semester during the year
No out-of-state tuition and fees

Designed for industry

The increasing complexity of the global animal health industry has created the need for enhanced training of employees involved in various aspects of the regulatory pathway.

What are regulatory issues critical to industry?

Enhanced understanding of the policies and regulatory requirements for USDA, FDA and EPA
Role of regulatory affairs in all aspects of business
Effective communication with regulatory agencies
Product lifecycle development and maintenance
GXP, validation, study design and applied statistics, including requirements for different regulators
Regulatory compliance
Global strategies including historical perspectives, social aspects and methods to ensure product safety

Curriculum

AAI 840. Regulatory Aspects of Drug and Vaccine Development in the Animal Health Industry (2 credit hours)
STAT 703. Introduction to Statistical Methods for the Sciences (3 credit hours)
AAI 841. Strategies in Preclinical and Clinical Research for Regulatory Affairs in Animal Health (2 credit hours)
AAI 842. Strategies in the Stewardship of Licensed Pharmaceuticals and Biologics in Animal Health (2 credit hours)
AAI 843. Regulatory Development of Animal Pharmaceuticals – FDA (2 credit hours)
AAI 844. Regulatory Development of Animal Pesticides – EPA (2 credit hours)
AAI 845. Regulatory Development of Animal Biologicals and Diagnostics – USDA (2 credit hours)

Course descriptions and instructors

Please note that graduate students must be seeking a degree to qualify for federal financial aid loans.

"There is a continuous demand for highly educated professionals who specialize in regulatory affairs. That demand for talent won't ever slow down. If anything, the need is increasing as the industry continues to discover new pharmaceuticals, therapeutics and products that improve animal health."

— Bill Zollers, vice president for regulatory affairs for North America at Norbrook Inc.