Regulatory Project Manager/Senior Manager

Job Description

Job Description

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.

The Impact You'll Have

• 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.

What We're Looking For

• 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.

About Maze Therapeutics

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.

Our People

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 – Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission.

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $143,000 – $175,000. Additionally, this position is eligible for an annual performance bonus.

Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

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