Manager, Regulatory Affairs

Maze Therapeutics • South San Francisco, CA

18h • $144,000 - $176,000 • Hybrid

About The Position

Maze Therapeutics is seeking a Manager, Regulatory Affairs to support the advancement of our clinical‑stage programs by contributing regulatory expertise and ensuring high‑quality execution of regulatory activities. In this role, you will collaborate closely with cross‑functional teams to coordinate regulatory submissions, support interactions with Health Authorities, and help drive the operational aspects of regulatory plans. Reporting to the Senior Director of Regulatory Affairs, you will work across clinical, nonclinical, and CMC functions to ensure regulatory deliverables are well‑organized, accurate, and aligned with development timelines. This is a great opportunity for a hands-on regulatory professional who is ready to take on increasing ownership and broaden their experience in a dynamic, fast-moving environment.

Requirements

• Bachelor’s degree required; advanced degree in life sciences is a plus.
• 4+ years of relevant experience in regulatory affairs within the biopharmaceutical industry.
• Solid understanding of ICH guidelines and US/EU regulatory requirements, with exposure to global submissions.
• Hands‑on experience preparing or contributing to IND/CTA submissions and related regulatory documentation; NDA/MAA exposure is beneficial but not required.
• Strong organizational skills with the ability to manage multiple tasks, track timelines, and anticipate challenges in a fast‑paced environment.
• Clear and effective communication skills, with the ability to convey regulatory concepts to cross‑functional partners.
• A collaborative mindset and comfort working in a dynamic, small‑company environment with evolving priorities and broad responsibilities.

Responsibilities

• Support Regulatory Affairs leads in representing RA for assigned programs by contributing regulatory guidance, identifying operational risks, and helping execute regulatory plans.
• Assist in the development and implementation of regulatory strategies in alignment with program objectives and global requirements.
• Conduct regulatory research and provide input on regulatory scenarios to help inform team decision‑making.
• Coordinate and track regulatory activities across clinical, nonclinical, and CMC functions to support timely program execution.
• Prepare, compile, and maintain regulatory submissions, including INDs/CTAs, amendments, periodic reports, expedited program requests, and responses to Health Authority questions.
• Contribute to the review of key program documents (e.g., clinical protocols, SAPs, study reports) to ensure alignment with regulatory expectations and submission readiness.
• Support the planning and execution of Health Authority interactions, including drafting or coordinating sections of briefing documents and organizing meeting materials.
• Collaborate with cross‑functional teams and external partners to ensure regulatory deliverables are complete, high‑quality, and consistent across documents.
• Participate in the development and ongoing improvement of Regulatory Affairs processes, tools, and documentation practices to enhance 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: Manager