Description

<h3>The Opportunity&nbsp;</h3> Maze Therapeutics is seeking a Manager, Regulatory Affairs to support the advancement of our clinical‑stage programs by contributing regulatory expertise and ensuring high‑quality execution of regulatory activities. In this role, you will collaborate closely with cross‑functional teams to coordinate regulatory submissions, support interactions with Health Authorities, and help drive the operational aspects of regulatory plans. Reporting to the Senior Director of Regulatory Affairs, you will work across clinical, nonclinical, and CMC functions to ensure regulatory deliverables are well‑organized, accurate, and aligned with development timelines. This is a great opportunity for a hands‑on regulatory professional who is ready to take on increasing ownership and broaden their experience in a dynamic, fast‑moving environment. <h3>The&nbsp;Impact You’ll Have</h3> <ul> <li>Support Regulatory Affairs leads in representing RA for assigned programs by contributing regulatory guidance, identifying operational risks, and helping execute regulatory plans.</li> <li>Assist in the development and implementation of regulatory strategies in alignment with program objectives and global requirements.</li> <li>Conduct regulatory research and provide input on regulatory scenarios to help inform team decision‑making.</li> <li>Coordinate and track regulatory activities across clinical, nonclinical, and CMC functions to support timely program execution.</li> <li>Prepare, compile, and maintain regulatory submissions, including INDs/CTAs, amendments, periodic reports, expedited program requests, and responses to Health Authority questions.</li> <li>Contribute to the review of key program documents (e.g., clinical protocols, SAPs, study reports) to ensure alignment with regulatory expectations and submission readiness.</li> <li>Support the planning and execution of Health Authority interactions, including drafting or coordinating sections of briefing documents and organizing meeting materials.</li> <li>Collaborate with cross‑functional teams and external partners to ensure regulatory deliverables are complete, high‑quality, and consistent across documents.</li> <li>Participate in the development and ongoing improvement of Regulatory Affairs processes, tools, and documentation practices to enhance compliance and operational efficiency.</li> </ul> <h3>What We’re Looking For</h3> <ul> <li>Bachelor’s degree required; advanced degree in life sciences is a plus.</li> <li>4+ years of relevant experience in regulatory affairs within the biopharmaceutical industry.</li> <li>Solid understanding of ICH guidelines and US/EU regulatory requirements, with exposure to global submissions.</li> <li>Hands‑on experience preparing or contributing to IND/CTA submissions and related regulatory documentation; NDA/MAA exposure is beneficial but not required.</li> <li>Strong organizational skills with the ability to manage multiple tasks, track timelines, and anticipate challenges in a fast‑paced environment.</li> <li>Clear and effective communication skills, with the ability to convey regulatory concepts to cross‑functional partners.</li> <li>A collaborative mindset and comfort working in a dynamic, small‑company environment with evolving priorities and broad responsibilities.</li> </ul> This role&nbsp;follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week.&nbsp;&nbsp; <h3>&nbsp;</h3> <h3>About Maze Therapeutics&nbsp;</h3> 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.&nbsp; Maze is based in South San Francisco.&nbsp; <h3>Our People&nbsp;</h3> 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.&nbsp;&nbsp; <h3>Our Core Values&nbsp;</h3> Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.&nbsp; 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. &nbsp; <hr> The expected annual salary range for employees located in the San Francisco Bay Area is $144,000-$176,000. 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.&nbsp;&nbsp; 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.&nbsp; #LI-Hybrid

Manager, Regulatory Affairs

Description

Maze Therapeutics

Pipeline