Senior Director, Regulatory Affairs South San Francisco, CA

Senior Director, Regulatory Affairs South San Francisco, CA Employer Maze Therapeutics Location South San Francisco, CA Start date May 12, 2026 View more categories View less categories Discipline Regulatory , Regulatory Affairs Required Education Bachelors Degree Position Type Full time Hotbed Biotech Bay Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details

INTERNAL MEDIA NOTICE OF FILING

Employer :

Maze Therapeutics Inc.

Position :

Senior Director, Regulatory Affairs (93488)

Duties :

Responsible for our development programs from preclinical candidate designation through drug approval. Provide regulatory leadership and guidance to project teams and work collaboratively with cross-functional team members, vendors and consultants to identify optimal and effective regulatory strategies for assigned projects. Develop and implement regulatory strategies for clinical development programs in alignment with corporate objectives and regulatory requirements. Offer regulatory considerations for the design, conduct, and interpretation of clinical trials. Identify and assess regulatory risks associated with development programs and define strategies to mitigate risks. Stay informed of emerging regulatory trends, guidance documents, and best practices related to clinical development and regulatory affairs. Prepare and lead teams through successful regulatory meetings and interactions. Lead the authoring, review and editing of high-quality, compliant regulatory documents according to specified timelines and goals. Provide insight and guidance on the implementation of current regulations and assess regulatory risk based on precedence. Mentor and develop the Regulatory Affairs team, fostering a culture of continuous improvement and excellence. Lead inspection readiness activities, including the preparation and coordination of mock and actual inspections. Contribute to the development and maintenance of Regulatory Affairs Department working practices and procedures.

Special Requirements:

Must have at least 2 years of prior work experience in each of the following: Supported development programs, provided regulatory expertise and support for development project work including regulatory review for clinical study teams, regulatory submissions and processes. Led efforts for coordinating content and publishing documents for INDs, Clinical Trial Applications and NDA/MAA, and their associated maintenance. Led the Regulatory Submission Teams, designed programs for complete and accurate IND/CTA submissions, and ensured that clinical trials are designed to meet regulatory requirements. Provided regulatory input for clinical development documents e.g., Investigator Brochures, annual Reports and DSURs, Safety Reports, Orphan Drug Application. Extensive submissions experience at the IND, CTA and

NDA/BLA/MAA

stages. Thorough understanding of drug laws such as Federal Food, Drug, and Cosmetic Act of 1938, Orphan Drug Act of 1983, FDA Amendments Act (FDAAA) of 2007, FDA Safety and Innovation Act (FDASIA), 21st Century Cures Act, Directive 2001/83/EC, Directive 2010/84/EU, Directive 2001/20/EC, Regulation (EC) No 726/2004 etc. Thorough understanding global regulations and requirements such as International Council for Harmonization (ICH) guidelines, FDA/EMA regulations and guidance, etc. •Telecommuting allowed for this position•Must hold Regulatory Affairs Certification (RAC)•

Education:

Master's or foreign equivalent in Regulatory Science, Pharmacy, Life Sciences, or related field

Experience:

10 years of experience in job offered or related occupation

Salary :

$304,300.00 - $325,000 / year

Worksite :

171 Oyster Point Blvd, Ste. 300, South San Francisco, CA 94080

Contact :

Kimberly Buck, Associate Director, Talent Acquisition This notice is being provided as a result of the filing of an application for permanent alien labor certification for this relevant job opportunity. Any person may provide documentary evidence bearing on the application to the Certifying Officer, U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification, 200 Constitution Avenue NW, Room N-5311, Washington, DC 20210. Company About Maze 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. We are advancing a pipeline using our Compass platform, which allows us 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 we refer to as variant functionalization. Our Compass platform has been purpose-built to inform all phases of our drug discovery and development process through clinical trial design. We are currently advancing two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease, or CKD. Our goal is to bring novel precision medicines to patients with common diseases, which is where we believe we can maximize our impact on human health. 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.

Company info Website https:

//mazetx.com/ Location 171 Oyster Point Blvd, Suite 300 South San Francisco

CA 94080

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