The Position: Maze Therapeutics is seeking a Director, Regulatory Affairs-CMC to be a key driver of CMC regulatory strategy for our clinical-stage small molecule programs. In this highly collaborative role, you will provide Regulatory-CMC expertise to support product development, regulatory submissions, and health authority interactions. Reporting to the Vice President of Regulatory and Quality Science, you will work closely with cross-functional teams and external stakeholders to navigate complex regulatory landscapes. Reporting to the Vice President of Regulatory and Quality Science, you will work closely with cross-functional teams and external stakeholders to navigate complex regulatory landscapes. This is a chance to shape the regulatory path for groundbreaking therapies in a highly collaborative and fast-moving environment. , applying informed and adaptable approaches to advance development goals. This is an opportunity to make a meaningful impact in a fast-paced environment, shaping the CMC regulatory pathway for transformative therapies.
The Impact You'll Have: - Develop and implement global Regulatory-CMC strategies that align with clinical development plans and long-term regulatory expectations.
- CMC regulatory requirements to enable efficient and effective development pathways, balancing speed, risk, and compliance.
- Support product development, manufacturing changes, and quality systems compliance across the product lifecycle.
- Proactively identify and collaborate cross-functionally to develop risk-mitigation strategies.
- Partner with CMC, Quality, and Supply Chain to Regulatory-CMC considerations into manufacturing processes, quality standards, and supply chain strategy.
- Oversee the planning, preparation, and review of CMC sections for global regulatory submissions, ensuring high-quality, phase-appropriate documentation.
- Prepare for and lead health authority interactions on CMC topics, effectively communicating regulatory strategies to drive successful outcomes.
- Stay informed of evolving global CMC regulatory trends key changes into actionable regulatory strategies to inform decision-making.
As a Director, we also expect our leaders to demonstrate the following Leadership Competencies:
- Communication and Influence
- Builds communication channels across Maze for sharing information
- Influences Senior Management decisions through persuasive arguments
- Respectfully addresses differing opinions leading to support of decision
- Teamwork and Collaboration
- Champions partnerships and connections across Maze
- Proactively addresses issues that could result in breakdown of team relationships
- Spotlights team and individual contributions in public forums
- Execution and Results
- Addresses gaps and leverages strengths to get best results
- Maintains a steadying presence and clarifies priorities during change
- Anticipates and removes barriers that put functional/corporate goals at risk
- Develop Others and Self
- Removes barriers to staff development and empowers them to make their own decisions
- Stays current on industry trends and keeps direct-reports prepared and responsive
What We're Looking For: - Master's or Ph.D. in chemistry, pharmaceutical sciences, or a related discipline preferred (or equivalent experience).
- 10+ years of industry experience, with deep expertise in Regulatory Affairs CMC.
- Strong knowledge of global CMC regulations, ICH guidelines, and regulatory requirements for small molecules.
- Experience working with CMOs and external partners to support manufacturing and development activities.
- Background in early-phase clinical development, with the ability to adapt CMC strategies through later-stage development.
- Proven experience in health authority interactions on CMC topics.
- Ability to thrive in a dynamic, fast-paced environment, managing multiple projects and evolving regulatory landscapes with agility.
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 is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco.
Our People Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.
Our Core Values Further Together - Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission.
Impact Obsessed - We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.
Stand True - Our 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 $219,000 - $267,000. 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.
