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
• 4-7+ 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

The Opportunity

Step into a pivotal role where science meets strategy. 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.

As our Head of Quality, you’ll shape and lead the Quality function at Maze, guiding strategy, systems, and compliance across our development programs. You’ll be instrumental in evolving our GxP processes and ensuring we’re inspection ready as we move into Phase 2 and beyond, with a focus on robust vendor oversight and building scalable systems to support late-stage and future commercial success.

Reporting to the Vice President of Regulatory and Quality Science, you’ll manage and develop two direct reports and foster a culture of collaboration, accountability, and continuous learning that extends across the organization.

The Impact You’ll Have

• Be accountable for and evolve Maze’s GxP Quality strategy, providing leadership across internal operations and external partners, including CROs, CMOs, CTLs, and vendors supporting GxP activities
• Drive cross-functional integration of Quality across programs, ensuring timely engagement in key decisions
• Develop and implement risk-based Quality approaches for investigational materials, ensuring phase-appropriate systems from early development through commercialization, and proactively identify and mitigate quality risks
• Lead the development and continuous improvement of Quality Systems and SOPs supporting GxP activities
• Provide Quality oversight and input for regulatory submissions and correspondence, including INDs, IMPDs, CTAs, and interactions with FDA and global health authorities
• Provide Quality leadership for clinical programs, including oversight of CROs and clinical trial activities, ensuring GCP compliance and readiness for clinical inspections
• Partner strategically with CMC and lead GMP vendor oversight to ensure manufacturing, testing, packaging, labeling, and distribution activities comply with cGMP, FDA, ICH, EMA, and industry standards.
• Lead QA investigations, including product-impacting issues, and provide oversight and approval of CAPAs from deviations, complaints, recalls, audits, and inspections, ensuring timely and effective resolution and closure of findings
• Drive Maze’s inspection readiness and serve as the lead Quality representative during health authority inspections
• Represent QA on cross-functional teams and company initiatives, providing Quality leadership and guidance in decision-making
• Stay current on evolving global regulations and industry best practices related to GxP and compliance, and apply these insights to strengthen Maze’s Quality frameworks and systems
• Develop and deliver GxP training across Maze, identifying opportunities for continuous improvement and embedding industry best practices into daily operations
• Oversee Document Control systems, ensuring compliance, consistency, and effective lifecycle management of Quality records

As a Senior Director, we also you to demonstrate the following Leadership Competencies:

• Communication and Influence
  • Role models clear communication and open two-way conversations.
  • Reinforces an environment where people feel heard and their opinions are valued.
  • Inspires followership despite differing initial opinions.
• Teamwork and Collaboration
  • Champions collaborations and connections across Maze.
  • Establishes team norms and expectations.
  • Seeks opportunities to spotlight team and individual contributions in public forums.
• Execution and Results
  • Develops recommendations to seize on opportunities and mitigate obstacles that could impact long-term success.
  • Coaches others on resource management and work distribution/delegation.
  • Aligns work to Maze’s strategy, mission, and vision.
• Develop Others and Self
  • Develops staff capabilities to handle delegation of responsibilities.
  • Encourages staff to develop and execute personal stretch goals.
  • Identifies and recommends ways to increase inclusive leadership.

What We’re Looking For

• Bachelor’s degree in a scientific discipline with 12+ years of progressive experience in biotech or pharma GxP quality assurance and compliance
• Deep knowledge of global GxP regulations, including U.S. CFR, EMA, ICH, and other relevant standards
• Proven experience in building and refining QA related systems that support clinical and commercial development
• Strong understanding of GMP Quality across raw materials, drug substance, drug product, labeling, packaging, and distribution, including testing, stability, and retention
• Strong understanding of GCP Quality, including CRO oversight, clinical trial conduct, and inspection readiness
• Experience enabling release of investigational and commercial materials in compliance with regulatory requirements
• Skilled in GxP training and implementation, with a focus on practical adoption
• Track record of leading and supporting regulatory inspections, including FDA, EMA, and global agencies
• Experience drafting audit responses and implementing CAPAs
• Proficiency in root cause analysis and CAPA management
• Familiarity with eQMS and eTMF systems
• Experience managing and developing direct reports, with a focus on mentorship and professional growth
• Collaborative mindset, with experience working across internal teams and external partners
• Strong strategic and organizational skills, with the ability to prioritize multiple projects
• Excellent leadership and communication skills (written and oral)
• High ethical standards with a positive, proactive, and solution-oriented approach
• Willingness to travel domestically and internationally for inspections, vendor oversight, and industry events

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 $257,000 - $314,000. 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