Regulatory Operations Specialist
Company: Maze Therapeutics
Location: South San Francisco
Posted on: February 26, 2026
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Job Description:
The Position 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. 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 . 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. LI-Hybrid
Keywords: Maze Therapeutics, Lodi , Regulatory Operations Specialist, Science, Research & Development , South San Francisco, California
