Skip to main content
RAPS Convergence 2025 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Invitation Only
Invitation Only
Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle

Gracie Sheng, MS

Technical Regulatory Program Director
Genentech

Gracie Sheng is the Program Director of the Pharm Technical Regulatory group at Genentech, a member of the Roche group. She serves as a technical regulatory lead for a wide range of programs, managing projects that span the entire product lifecycle—from the Investigational New Drug (IND) phase through New Drug Application (NDA) submission and post-market maintenance. Her deep regulatory experience covers both synthetic molecules and complex biological products. Notably, one of her programs achieved the fastest NDA approval in 2024. Before her current role, Gracie held key positions at Genentech in Quality functions, as Quality Product Lead and External Quality senior manager. Her broad career foundation was established through her previous roles in various pharmaceutical companies, including Novo Nordisk, specializing in Analytical and Formulation Development. Gracie holds a Master of Science degree in Analytical Chemistry from Brigham Young University (USA) and a Bachelor of Science degree in Applied Chemistry from Fudan University (China). She is an active industry contributor, currently serving as a member of the Peptide Working Group under the IQ Consortium.

Presentation(s):