Regulatory Operations Specialist

The Opportunity

Maze Therapeutics is seeking a Regulatory Operations Specialist to manage regulatory operations across development-stage programs. In this role, you will translate regulatory strategy into disciplined, reliable operational delivery and anticipate and address execution challenges that affect submission quality and timing. 

The position reports to the VP of Regulatory and Quality Science and collaborates across teams to ensure consistent, high-quality regulatory execution. 

The Impact You’ll Have

• Manage the preparation, coordination, and execution of regulatory submissions (e.g., IND/CTA, amendments, briefing materials) across development programs. 
• Identify and proactively communicate execution risks, dependencies, and timeline constraints to support effective regulatory planning and timely submissions. 
• Maintain submission trackers, timelines, and regulatory calendars to ensure accurate visibility into regulatory milestones and commitments. 
• Coordinate with external publishing vendors to ensure timely compilation and delivery of submission files. 
• Perform quality control (QC) review of submission outputs to ensure completeness, internal consistency, and technical readiness for submission. 
• Maintain official regulatory records and archives to support inspection and diligence readiness. 
• Track Health Authority correspondence and submission history to ensure visibility of follow-up commitments and support internal regulatory planning. 
• Identify and implement improvements to processes, tools, and documentation standards to enhance regulatory quality and efficiency. 

What We’re Looking For

• Bachelor’s degree in a scientific or related discipline. 
• 4+ years in regulatory operations or regulatory affairs with direct involvement in regulatory submissions. 
• Experience performing QC review of published submission outputs and managing submission timelines. 
• Familiarity with submission deliverables, version control practices, and submission lifecycle management. 
• Strong organizational skills, attention to detail, and ability to manage multiple tasks concurrently. 
• Strong written and verbal communication skills to clearly convey operational considerations and collaborate effectively with internal and external stakeholders. 
• Experience coordinating with external vendors or publishing partners is preferred. 

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week.  

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease.  Maze is based in South San Francisco.

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 $113,000-139,000. 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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