Animal Health Regulatory Affairs

• 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 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.

With the proper education and experience, regulatory affairs professionals can have positions such as:

• Clinical Research Coordinator

• Compliance Manager

• Regulatory Affairs Manager

• Regulatory Affairs Specialist

Industry Demand

"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.

• 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.

Required (15 credit hours)

• 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 (1 credit hour)
  
  
• 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)
  
  
• AAI 846 — Special Topics: Regulatory Affairs in Animal Health (1 credit hour)

Course descriptions and instructors

Students who live in Johnson County and who are applying to this program may be eligible for a Johnson County resident scholarship.

These scholarships for Johnson County residents are sponsored by the Johnson County Education and Research Triangle, or JCERT. Scholarship awards are based on availability of funds. Applicants may be awarded up to $5,000 for the duration of their program of study, provided they meet minimum academic and enrollment requirements. Scholarship amounts vary depending on fund availability, merit and need.

Eligibility details:

• Applicant must be a resident of Johnson County, Kansas. Proof of residency will be required.
• Applicants must be resident at K-State Olathe and admitted to or seeking admission to the following JCERT mission-related programs:
  • Animal Health Regulatory Affairs (certificate)

Apply for a Johnson County resident scholarship.

View all scholarships available at K-State Olathe.