Julie Spyrison

Julie joined BioTechLogic in 2004 with a focus in CMC Regulatory and Program Management.  Within the BioTechLogic team, Julie is responsible for managing global CMC Regulatory submission projects and preparation of CMC documentation.  As part of the dossier preparation and its lifecycle management, Julie performs source document gap analyses; authors Agency meeting requests and briefing packages, Module 2.3 and Module 3 CTD sections, responses to Agency questions; facilitates the electronic publishing process, and evaluates change control requests post-dossier submission for Regulatory impact.  She also serves as the CMC Regulatory lead for several clients who do not have the function in-house, leading the team in developing global CMC Regulatory strategies for all phases of development.

Julie also provides clients with program and portfolio management support across all drug modalities. Responsibilities include developing and managing project plans associated with the Drug Substance and Drug Product contract manufacturing sites, process scale-up and technology transfer, process validation, regulatory submission packages, and global regulatory inspection readiness.  

Previously, she was a project manager at Integrated Project Management Company, Inc. During her tenure there she managed projects at Searle, Pharmacia and Pfizer, related to business process improvement initiatives and program management of product development programs.  She holds a B.S. in Chemical Engineering from Northwestern University.

• CMC Regulatory Lead
• Primary author for CMC Module 3 and Module 2.3 sections and all other CMC Regulatory documentation
• Program Management support across all development milestones

Member of CASSS, ASGCT, and Alliance for Regenerative Medicine

BioTechLogic, Inc.
Director, Regulatory Operations

Integrated Project Management Company, Inc.
Program Manager on assignment at Searle, Pharmacia, Pfizer

Northwestern University
BS in Chemical Engineering