CMC Consultant
GSK
Wake Forest, North Carolina
Sue is a Consultant in CMC Regulatory Affairs with GSK. In her role she is responsible for providing strategic advice in support of manufacturing site change projects for respiratory products and is a Subject Matter Expert for Devices and Combination Products.
Sue originally joined GSK in 1988 as an analyst leading the analytical development of respiratory products. She moved to CMC regulatory affairs in 2002 continuing with GSKs respiratory products, spanning clinical trial, marketing application and post-approval variation global submissions. Sue transitioned to a consulting role in 2023.
Sue has a BS in Chemistry with Analytical Chemistry and Toxicology, and a MS in Pharmaceutical Analysis and Quality Control. She currently represents GSK on the IPAC-RS Board of Directors, co-chairs the IPAC-RS North America Outreach Working Group and co-chairs the IPAC-RS Alternate Propellant Working Group.
Hot Topic: Regulatory Challenges and Considerations for Orally Inhaled Drug Product
Tuesday, October 24, 2023
10:00 AM – 11:00 AM ET