Director, Regulatory Affairs - Maze Therapeutics

Join Maze Therapeutics as a Director, Regulatory Affairs, where you will play a critical leadership role in advancing our clinical-stage programs, providing regulatory expertise to guide their progress. As a strategic leader and regulatory-clinical expert, you’ll serve as the Global Regulatory Lead, collaborating with cross-functional teams to develop, review, and execute regulatory strategies that are critical to the success of ongoing clinical trials and foundational for future marketing authorizations. Reporting to the Vice President of Regulatory and Quality Science, you'll play a key role in navigating complex regulatory landscapes to ensure our programs achieve key milestones and deliver meaningful outcomes. In this role, you’ll have the opportunity to make a significant impact in a dynamic environment contributing to the advancement of transformative therapies.

• Provide regulatory leadership and guidance to project teams, collaborating with cross-functional team members, vendors and consultants to identify optimal and effective regulatory strategies for assigned projects
• Develop and implement regulatory strategies for clinical development programs in alignment with corporate objectives and regulatory requirements
• Identify and assess potential regulatory risks associated with development programs, defining proactive strategies to mitigate them and support program advancement
• Stay informed of emerging regulatory trends, guidance documents, and best practices related to clinical development and regulatory affairs
• Prepare for and lead teams through successful health authority meetings and interactions
• Lead and oversee the authoring, review, and editing of high-quality, compliant regulatory documents according to specified timelines and objectives
• Contribute to the continuous improvement of the Regulatory Affairs team by developing and maintaining best practices and procedures

 As a Director, we also expect our leaders to demonstrate the following 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

• Bachelor's degree required; advanced degree in life sciences
• 10+ years of relevant regulatory affairs experience, with a strong understanding of clinical trials
• Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs
• Experience and expertise in the preparation of IND/CTAs (required) and NDA/BLA/MAAs (preferred), as well as supportive amendments and supplements
• Demonstrated ability to manage multiple projects, proactively identifying potential problems and to partner effectively and positively to solve issues
• Excellent organizational and communication skills, both written and verbal
• Well-prepared, proactive, and comfortable handling broad responsibilities in a fast-paced, small company environment

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.

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.

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 $226,000 - $277,000. 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.