Maze Therapeutics-posted 3 months ago
$196,000 - $240,000/Yr
Full-time • Senior
Hybrid • South San Francisco, CA
101-250 employees
Professional, Scientific, and Technical Services

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, supporting interactions with Health Authorities, and ensuring successful execution of regulatory plans.

  • 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 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.
  • 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 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.
  • Competitive medical, dental, and vision insurance
  • Mental health offerings
  • Equity incentive plan
  • 401(k) program with employer match
  • Generous holiday and PTO policy
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