Associate Director, Regulatory Affairs South San Francisco, CA
Company: Maze Therapeutics
Location: South San Francisco
Posted on: March 19, 2026
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Job Description:
The Opportunity: Join Maze Therapeutics as an Associate
Director, Regulatory Affairs , where you will play a critical role
in advancing our clinical-stage programs by providing regulatory
expertise and executional leadership. As a key member of the
development team, you will collaborate with cross-functional teams
to manage and support global regulatory activities. Reporting to
the Senior Director of Regulatory Affairs, you will be responsible
for preparing regulatory submissions, facilitating interactions
with Health Authorities, and ensuring successful execution of
regulatory plans. The Impact You’ll Have: Represent Regulatory
Affairs for assigned programs, providing regulatory leadership and
guidance, identifying regulatory risks and developing mitigation
strategies, and leading the execution of regulatory plans.
Contribute to the development and implementation of regulatory
strategies for assigned programs in alignment with corporate
objectives and regulatory requirements. Conduct regulatory research
to provide recommendations for various regulatory scenarios,
proactively identify risks, and inform regulatory strategies. Plan
and manage regulatory activities across clinical, nonclinical, and
CMC functions to enable timely and efficient program advancement.
Lead the preparation and maintenance of regulatory submissions,
including INDs/CTAs, periodic reports, expedited program requests,
and Health Authority responses. Provide regulatory input on key
development documents, including clinical protocols, statistical
analysis plans, and clinical/nonclinical study reports, to ensure
alignment with regulatory expectations. Support the planning,
preparation, and execution of Health Authority interactions by
contributing to meeting strategy, drafting briefing documents, and
coordinating responses. Collaborate with cross-functional teams and
external partners to ensure regulatory deliverables are
high-quality and aligned with development timelines. Champion the
development and continuous improvement of Regulatory Affairs
processes to enhance compliance and operational efficiency. What
We’re Looking For: Bachelor's degree required; advanced degree in
life sciences 7 years or equivalent relevant experience in
regulatory affairs in the biopharmaceutical industry Strong
understanding of ICH guidelines and US/EU regulatory requirements,
with experience supporting global regulatory filings Hands-on
experience preparing and managing IND/CTAs and related submissions
required; NDA/MAA experience a plus Ability to manage multiple
projects in a fast-paced environment, proactively identifying
challenges and collaborating cross-functionally to develop
solutions Strong organizational and communication skills, with the
ability to clearly convey regulatory concepts to cross-functional
teams 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
$199,000-244,000. 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. LI-Hybrid
Keywords: Maze Therapeutics, Hayward , Associate Director, Regulatory Affairs South San Francisco, CA, Science, Research & Development , South San Francisco, California
