Associate Director, Regulatory Affairs South San Francisco, CA

The Opportunity

Join Maze Therapeutics as an Associate Director, 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, facilitating interactions with Health Authorities, and ensuring successful execution of regulatory plans.

The Impact You’ll Have

• Represent Regulatory Affairs for assigned programs, providing regulatory leadership and guidance, identifying regulatory risks and developing mitigation strategies, and leading the execution of regulatory plans.
• Contribute to 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.
• Lead the 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.
• Champion the development and continuous improvement of Regulatory Affairs processes to enhance compliance and operational efficiency.

What We’re Looking For

• Bachelor’s degree required; advanced degree in life sciences
• 4-7+ 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

Hybrid schedule: an expectation to be onsite at South San Francisco headquarters at least three days per week.

Salary and Benefits

The expected annual salary range for employees located in the San Francisco Bay Area is $199,000‑244,000. 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.

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