Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs

Join Maze Therapeutics as a Senior Manager, 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, supporting interactions with Health Authorities, and ensuring successful execution of regulatory plans.

• Represent Regulatory Affairs for assigned programs, providing regulatory guidance, identifying regulatory risks and developing mitigation strategies, and supporting the execution of regulatory plans.
• Support 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.
• Prepare and maintain regulatory submissions, including INDs/CTAs, periodic reports, expedited program requests, and Health Authority responses.
• Contribute to the preparation of key documents, including clinical protocols, statistical analysis plans, and clinical/nonclinical study reports, by providing regulatory review and ensuring 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.

• Bachelor's degree required; advanced degree in life sciences.
• 5+ 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.

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, MZE
829 and MZE
782, 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…