Regulatory Affairs 101 for STEM PhDs

This course introduces participants to the fundamentals of regulatory affairs in the healthcare industry, focusing on FDA-regulated products. Through three focused sessions, learners will explore career opportunities, understand FDA’s role in drug and device regulation, and gain practical insights into submission processes for product approval.

In this mini-course you will learn about:

• The purpose and scope of regulatory affairs in healthcare
• FDA’s regulatory framework for drugs and medical devices
• Key submission types and approval pathways
• Career paths, required skills, and industry trends in regulatory affairs

Dates & Times

Dates: Thursday 9/11, Tuesday 9/16, Thursday 9/18 | 4 – 6 p.m.
Location: In-Person Sessions (UChicago Campus)
Target Audience: PhD students and postdoctoral fellows exploring careers in regulatory affairs

Session Description:

Session 1: Careers in Regulatory Affairs

• • Overview of Regulatory Affairs (RA)
  • Career Path & Job Outlook:
  • Skills & Qualifications
  • Practical job tasks of a regulatory professional

Session 2: FDA and Regulations

• • History & Evolution of FDA
  • FDA’s Scope & Mission
  • Regulatory Framework – laws, regulations and guidelines
  • Tools to navigate regulatory landscape

Session 3: Drug and Medical Devices

• • Regulatory framework of drug development
  • Drug regulatory submissions
  • Medical Devices
  • Post-Market Compliance

Instructor

Ketrija, Tou, PhD, Regulatory Affairs Manager, Abbott
Ketrija is a regulatory affairs professional with over a decade of industry experience, combining expertise in global regulatory strategy with a strong foundation in molecular diagnostics research and development. Currently serving as a Regulatory Affairs Manager, she has developed regulatory strategies for diagnostic technologies, including companion diagnostics and infectious disease assays. Her work bridges early-stage assay development with regulatory submission planning, ensuring compliant, market-ready product development.
Before transitioning into regulatory affairs, Ketrija spent more than 10 years in academic research. She holds a Ph.D. in Physiology from Indiana University School of Medicine and completed her postdoctoral fellowship at the University of Chicago, where she led NIH-funded studies on gut microbiota and digestive diseases. She also holds dual certifications in Regulatory Affairs & Compliance for Pharmaceuticals and Medical Devices from UC Irvine.
Ketrija is passionate about mentoring and advancing communication within the regulatory field. She is excited to bring practical, real-world perspective to students interested in pursuing regulatory affairs, equipping them with the tools and insights needed to succeed in a dynamic and evolving industry.

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