Senior Manager, Regulatory Affairs

Maze Therapeutics • South San Francisco, CA

7h • $180,000 - $220,000 • Hybrid

About The Position

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.

Requirements

• 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

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 101-250 employees