Maze Therapeutics · 1 day ago
Senior Manager, Regulatory Affairs
South San Francisco, CA
Full-time
Hybrid
Senior Level
$180K/yr - $220K/yr
5+ years expMaze Therapeutics is a clinical-stage biopharmaceutical company focused on developing precision medicines through human genetics. The Senior Manager, Regulatory Affairs will provide regulatory expertise and leadership, manage global regulatory activities, and ensure the successful execution of regulatory plans for clinical-stage programs.
BiopharmaBiotechnologyGeneticsTherapeutics
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
Qualification
Required
Bachelor's degree required
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
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
Preferred
Advanced degree in life sciences
NDA/MAA experience a plus
Benefits
Competitive medical, dental, and vision insurance
Mental health offerings
Equity incentive plan
401(k) program with employer match
Generous holiday and PTO policy
Company
Maze Therapeutics
Maze Therapeutics is a biotechnology company that develops precision medicines for renal, cardiovascular, and metabolic diseases.
51-200 employees
H1B Sponsorship
Maze Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (2)
2022 (5)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$646MKey Investors
Matrix Capital ManagementCity Hill Ventures
2025-09-11Post Ipo Equity· $150M
2025-01-31IPO
2024-12-03Series D· $115M
Leadership Team
Jason Coloma
Chief Executive Officer
Misbah Tahir
Chief Financial Officer
Recent News
2026-01-06
Maze Therapeutics, Inc.
2025-11-09
StreetInsider.com
2025-11-07
Company data provided by crunchbase