🚀 Associate Director, Regulatory Affairs

Position Overview

Join Maze Therapeutics as an Associate Director, Regulatory Affairs. In this role you will play a critical part in advancing our clinical‑stage programs by providing regulatory expertise and executional leadership. You will collaborate with cross‑functional teams to manage and support global regulatory activities. Reporting to the Senior Director of Regulatory Affairs, you will prepare regulatory submissions, support interactions with Health Authorities, and ensure successful execution of regulatory plans.

Impact You’ll Have

• 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 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
  • Build communication channels across Maze for sharing information.
  • Influence Senior Management decisions through persuasive arguments.
  • Respectfully address differing opinions leading to support of decision.
• Teamwork and Collaboration
  • Champion partnerships and connections across Maze.
  • Proactively address issues that could result in breakdown of team relationships.
  • Spotlight team and individual contributions in public forums.
• Execution and Results
  • Address gaps and leverage strengths to get best results.
  • Maintain a steadying presence and clarify priorities during change.
  • Anticipate and remove barriers that put functional/corporate goals at risk.
• Develop Others and Self
  • Remove barriers to staff development and empower them to make their own decisions.
  • Stay current on industry trends and keep 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 linked to disease pathways and then links those variants to specific patient groups through variant functionalization. The pipeline is led by two wholly owned programs, MZE829 and MZE782, representing novel precision‑medicine approaches for chronic kidney disease. Maze is based in South San Francisco.

Salary & Benefits

The expected annual salary range for employees located in the San Francisco Bay Area is $196,000–$240,000, plus an annual performance bonus. The position is eligible for equity incentive and comprehensive benefits, including medical, dental, vision, mental health, 401(k) with employer match, and generous holiday and PTO policy.