Senior Manager, Regulatory Affairs
Maze Therapeutics(1 month ago)
About this role
The Senior Manager, Regulatory Affairs at Maze Therapeutics provides regulatory expertise and executional leadership for clinical-stage programs, working closely with cross-functional teams to advance development. The role reports to the Senior Director of Regulatory Affairs and focuses on preparing regulatory submissions, supporting Health Authority interactions, and ensuring alignment with global regulatory requirements. The position contributes to regulatory strategy, compliance, and process improvement to enable timely program progression.
Required Skills
- Regulatory Guidance
- Risk Mitigation
- Regulatory Strategy
- Regulatory Research
- Submission Preparation
- IND/CTA Management
- Authority Interactions
- Clinical Documentation
- CMC Coordination
- Protocol Review
+7 more
Qualifications
- Bachelor's Degree
- Advanced Degree in Life Sciences
About Maze Therapeutics
mazetx.comMaze Therapeutics (branded "Genetic Navigators") is a biotechnology company that translates human genetic data into validated drug targets. They combine large-scale human genetics, computational analysis, and functional genomics to prioritize targets with strong causal evidence. Their platform is designed to accelerate and de-risk drug discovery, supporting internal development programs and collaborations with partners to advance new therapies.
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