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About the Role

This role supports regulatory planning, timeline management, and cross-functional coordination for Maze's development programs, ensuring regulatory activities, health authority interactions, and submission workstreams are organized and progressing. You will help build practical project management approaches to support key regulatory milestones as Maze advances its clinical programs.

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.

Requirements

• 5+ years of project management experience in the biopharmaceutical industry, with experience supporting Regulatory Affairs, clinical development, or regulatory submission activities.
• 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.
• 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.

Skills

• Project management
• Regulatory Affairs support
• Timeline management
• Cross-functional coordination
• Document development tracking
• Risk identification
• Project management tools proficiency
• Organizational judgment
• Attention to detail
• Communication
• Collaboration

Location

• San Francisco Bay Area

Work Type

• Hybrid

Experience Level

• 5+ years

Education Level

• Bachelor’s degree in a scientific, health-related, or business discipline required
• Advanced degree or project management certification preferred

Salary/Compensations

• $143,000 – $175,000
• Eligible for an annual performance bonus

Benefits

• Competitive medical, dental, and vision insurance
• Mental health offerings
• Equity incentive plan
• 401(k) program with employer match
• Generous holiday and PTO policy

About the Company

• Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing human genetics to develop precision medicines for patients with kidney and metabolic diseases.
• Our clinical pipeline is anchored by two small molecule programs: MZE829, an APOL1 inhibitor for patients with APOL1‑mediated kidney disease, and MZE782, which targets genetic drivers of disease in phenylketonuria (PKU) and chronic kidney disease.
• We are also advancing a preclinical pipeline through our Compass platform, which links human genetic variants to the biological pathways that drive disease.
• Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases.
• We are fostering a culture that encourages vision, initiative and the development of talent.
• Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work.
• While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.
• Our Core Values: Further Together, Impact Obsessed, Stand True.