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Maze Therapeutics is seeking a Regulatory Project Manager to bring structure, visibility, and execution discipline to the growing Regulatory function. You will play a key role in supporting regulatory planning, timeline management, and cross-functional coordination across Maze's clinical development programs.
In this role, you will:
- Maintain integrated plans and timelines for regulatory activities, including health authority interactions, IND amendments, annual reports, major program milestones, and future submission activities.
- Partner with Medical Writing to track document development timelines, review cycles, comment resolution, approvals, and readiness dates for key clinical and regulatory documents.
- Coordinate with Regulatory Affairs, Medical Writing, and Regulatory Operations to ensure regulatory activities and submission-related workstreams are organized and moving forward with appropriate accountability.
- Support timely execution of key regulatory milestones as Maze advances its clinical programs toward later-stage development.
- Build practical project management approaches that enhance cross-functional collaboration and visibility.
You will report to the VP of Regulatory and Quality Science. This position is ideal for someone with strong project management experience in a regulated biotech or pharma environment, excellent organizational skills, and the ability to work effectively across multiple teams. You should be comfortable with complex timelines, regulatory requirements, and health authority interactions.
