Regulatory Project Manager/Senior Manager

Maze Therapeutics•South San Francisco, CA

2d•$143,000 - $175,000•Hybrid

About The Position

This is an opportunity to help bring structure, visibility, and execution discipline to a growing Regulatory function at Maze. At Maze, we’re on a mission to uncover genetic insights and transform them into precision medicines that change lives. Our team is driven by curiosity, collaboration, and a commitment to improving treatment for people with severe diseases. We thrive on diverse perspectives and bold ideas, and we’re looking for someone who shares that spirit. As our Project Manager, Regulatory Affairs, you’ll play a key role in supporting regulatory planning, timeline management, and cross-functional coordination across Maze’s development programs. You’ll help ensure that regulatory activities, health authority interactions, medical writing timelines, and submission-related workstreams are organized and moving forward with appropriate accountability. Working closely with Regulatory Affairs, Medical Writing, and Regulatory Operations, you’ll help build practical project management approaches that support timely execution of key regulatory milestones as Maze advances its clinical programs toward later-stage development. This position reports to the VP, Regulatory and Quality Science.

Requirements

5+ years of project management experience in the biopharmaceutical industry, with experience supporting Regulatory Affairs, clinical development, or regulatory submission activities.
Bachelor’s degree in a scientific, health-related, or business discipline required; advanced degree or project management certification preferred.
Working knowledge of drug development and regulatory processes, including health authority interactions, IND maintenance activities, and major clinical development milestones.
Demonstrated ability to build and manage project plans, timelines, trackers, dashboards, meeting agendas, and status updates across cross-functional teams; proficiency with common project management tools preferred.
Strong organizational judgment and attention to detail, with the ability to track actions, dependencies, decisions, risks, and follow-ups across multiple workstreams.
Excellent communication and collaboration skills, with the ability to work effectively in a hands-on, fast-paced biotech environment with internal stakeholders and external partners.

Nice To Haves

advanced degree or project management certification preferred

Responsibilities

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 cross-functional contributors across regulatory, clinical, technical, quality, and external partner teams to keep regulatory workstreams moving.
Track actions, owners, due dates, dependencies, open questions, decisions, and follow-ups to ensure regulatory activities remain organized and accountable.
Identify timeline risks, bottlenecks, resource constraints, unresolved decisions, and readiness issues early, and escalate appropriately.
Prepare agendas, meeting summaries, dashboards, and status updates that give the Regulatory team clear visibility into priorities, progress, and risks.
Help establish fit-for-purpose project management tools, trackers, templates, and working practices that create structure without adding unnecessary process burden.