BioSpace
The Position
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. Responsibilities
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. Leadership Competencies
Communication and Influence: Builds communication channels across Maze, influences senior management decisions, and respectfully addresses differing opinions to gain support for decisions. Teamwork and Collaboration: Champions partnerships, proactively addresses issues that could affect team relationships, and highlights contributions in public forums. Execution and Results: Addresses gaps, maintains priorities during change, and removes barriers to achieve goals. Develop Others and Self: Removes barriers to staff development and stays current on industry trends to prepare and respond effectively. What We’re Looking For
Bachelor's degree required; advanced degree in life sciences preferred. 7+ years or equivalent regulatory affairs experience 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; NDA/MAA experience is 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. About Maze Therapeutics
Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company advances a pipeline using its Compass platform to identify and characterize genetic variants in disease and link those variants to biological pathways that drive disease in specific patient groups through variant functionalization. The pipeline is led by two lead programs, MZE829 and MZE782. Maze is based in South San Francisco. Our People and Core Values
Maze is comprised of a team of passionate professionals committed to discovering and delivering transformative medicines to patients. We foster a culture of vision, initiative and talent development in a supportive environment that encourages creative thinking and freedom of expression. Our work is guided by patient impact, excellence in execution, and integrity. Further Together
– Our path is paved with challenges, but with a team-first mentality, we’ll achieve our mission. Impact Obsessed
– We embrace bold moves, take calculated risks, and learn from mistakes to improve lives. Stand True
– Integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $196,000-240,000. This position is eligible for an annual performance bonus. Maze conducts position-based compensation benchmarking to market data to ensure competitive wages. Starting salary is determined by factors including experience, skills and location, and may be modified in the future. Maze offers a robust benefits package including medical, dental, and vision insurance, mental health offerings, an equity incentive plan, a 401(k) with employer match, and generous holiday and PTO policy.
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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. Responsibilities
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. Leadership Competencies
Communication and Influence: Builds communication channels across Maze, influences senior management decisions, and respectfully addresses differing opinions to gain support for decisions. Teamwork and Collaboration: Champions partnerships, proactively addresses issues that could affect team relationships, and highlights contributions in public forums. Execution and Results: Addresses gaps, maintains priorities during change, and removes barriers to achieve goals. Develop Others and Self: Removes barriers to staff development and stays current on industry trends to prepare and respond effectively. What We’re Looking For
Bachelor's degree required; advanced degree in life sciences preferred. 7+ years or equivalent regulatory affairs experience 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; NDA/MAA experience is 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. About Maze Therapeutics
Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company advances a pipeline using its Compass platform to identify and characterize genetic variants in disease and link those variants to biological pathways that drive disease in specific patient groups through variant functionalization. The pipeline is led by two lead programs, MZE829 and MZE782. Maze is based in South San Francisco. Our People and Core Values
Maze is comprised of a team of passionate professionals committed to discovering and delivering transformative medicines to patients. We foster a culture of vision, initiative and talent development in a supportive environment that encourages creative thinking and freedom of expression. Our work is guided by patient impact, excellence in execution, and integrity. Further Together
– Our path is paved with challenges, but with a team-first mentality, we’ll achieve our mission. Impact Obsessed
– We embrace bold moves, take calculated risks, and learn from mistakes to improve lives. Stand True
– Integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $196,000-240,000. This position is eligible for an annual performance bonus. Maze conducts position-based compensation benchmarking to market data to ensure competitive wages. Starting salary is determined by factors including experience, skills and location, and may be modified in the future. Maze offers a robust benefits package including medical, dental, and vision insurance, mental health offerings, an equity incentive plan, a 401(k) with employer match, and generous holiday and PTO policy.
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