Description
The Regulatory Affairs and Quality Assurance (RAQA) Project Manager serves as a strategic project management partner to Regulatory Affairs and Quality Assurance leadership, integrating regulatory strategy execution and quality-assurance readiness across development programs. The role manages regulatory submission plans, health authority interactions, NDA and post-approval activities, inspection readiness, quality-system deliverables, governance, reporting, budgets, and external vendors. It requires a bachelor's degree in a relevant field or equivalent experience, at least 8 years of pharmaceutical or biotechnology experience, substantial regulatory Affairs experience, and at least 3 years of cross-functional program or project management responsibility.
