Associate Director, Regulatory Affairs

Overview

Associate Director, Regulatory Affairs at Maze Therapeutics. You will provide regulatory expertise and executional leadership to advance our clinical-stage programs, collaborating with cross-functional teams to manage global regulatory activities. You will report to the Senior Director of Regulatory Affairs and be responsible for preparing regulatory submissions, supporting interactions with Health Authorities, and ensuring successful execution of regulatory plans.

The Position

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 groups to manage and support global regulatory activities.

Responsibilities

• Represent Regulatory Affairs for assigned programs, providing regulatory guidance, identifying submission risks, and supporting the development and execution of regulatory plans.
• 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.
• Contribute to the development and continuous improvement of Regulatory Affairs processes to support compliance and operational efficiency.

Leadership Competencies

• Communication and Influence
  • Builds communication channels across Maze for sharing information
  • Influences Senior Management decisions through persuasive arguments
  • Respectfully addresses differing opinions leading to support of decision
• Teamwork and Collaboration
  • Champions partnerships and connections across Maze
  • Proactively addresses issues that could result in breakdown of team relationships
  • Spotlights team and individual contributions in public forums
• Execution and Results
  • Addresses gaps and leverages strengths to get best results
  • Maintains a steadying presence and clarifies priorities during change
  • Anticipates and removes barriers that put functional/corporate goals at risk
• Develop Others and Self
  • Removes barriers to staff development and empowers them to make their own decisions
  • Stays current on industry trends and keeps direct reports prepared and responsive

What We’re Looking For

• Bachelor's degree required; advanced degree in life sciences preferred.
• 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
• Comfortable working in a dynamic, small-company environment with broad responsibilities and evolving priorities

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 identifies and characterizes genetic variants in disease and links them to the biological pathways that drive disease in specific patient groups. Maze is based in South San Francisco.

Our People and Values

Maze is comprised of a team of professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We foster a culture that encourages vision, initiative and talent development. 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 science and excellence in execution, 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 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.

Compensation

The expected annual salary range for employees located in the San Francisco Bay Area is $196,000-$240,000. This position is eligible for an annual performance bonus. Starting salary will depend on experience, skills, and location. The salary range may be modified in the future. Maze provides a comprehensive benefits package including medical, dental, and vision insurance, mental health offerings, an equity incentive plan, a 401(k) with employer match, and generous holiday and PTO.