Regulatory Affairs - Eli Lilly

Preceptor Gail Uminger 

Description The Global Operations Labeling Department (GOLD) facilitates the creation and maintenance of
Global Product Information for commercialized products and products in development. Specifically, GOLD is
responsible for development and accurate updating of US labeling documents (physician package insert, patient
package insert, carton, and immediate container label). Also, GOLD develops and maintains the Core Data Sheet,
global labeling document. GOLD staff interact with the global labeling team, product teams, and Regulatory Affairs
personnel involved in the drug development process, providing therapeutic, process, and regulatory expertise on
labeling issues. 

Objectives 
1. Provide the student with experience in the pharmaceutical industry 

2. Familiarize the student with the role of Regulatory Affairs in the pharmaceutical industry and the drug
development process 

3. Provide the student with experience in locating, interpreting, and using regulations, guidances, and other
regulatory information documents. 

4. Provide the student with exposure to product labeling