Regulatory Project Manager/Senior Manager

About the role

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.

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.
• Cook up 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.
• Bachelor’s degree in a scientific, health-related, or business discipline required; advanced degree or project management certification preferred.
• 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.

Qualifications

• Working knowledge of drug development and regulatory processes, including health authority interactions, IND maintenance activities, and major clinical development milestones.
• 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
• Health Authority Interactions
• Medical Writing
• Timeline Management
• Collaboration

Benefits

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

Pay

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.

Schedule

Maze offers a flexible schedule to accommodate the needs of our employees.