Regulatory Operations Specialist

Maze Therapeutics•South San Francisco, CA

6h•Hybrid

About The Position

Maze Therapeutics is seeking a Regulatory Operations Specialist to manage regulatory operations across development-stage programs. In this role, you will translate regulatory strategy into disciplined, reliable operational delivery and anticipate and address execution challenges that affect submission quality and timing. The position reports to the VP of Regulatory and Quality Science and collaborates across teams to ensure consistent, high-quality regulatory execution.

Requirements

Bachelor’s degree in a scientific or related discipline.
4+ years in regulatory operations or regulatory affairs with direct involvement in regulatory submissions.
Experience performing QC review of published submission outputs and managing submission timelines.
Familiarity with submission deliverables, version control practices, and submission lifecycle management.
Strong organizational skills, attention to detail, and ability to manage multiple tasks concurrently.
Strong written and verbal communication skills to clearly convey operational considerations and collaborate effectively with internal and external stakeholders.

Nice To Haves

Experience coordinating with external vendors or publishing partners is preferred.

Responsibilities

Manage the preparation, coordination, and execution of regulatory submissions (e.g., IND/CTA, amendments, briefing materials) across development programs.
Identify and proactively communicate execution risks, dependencies, and timeline constraints to support effective regulatory planning and timely submissions.
Maintain submission trackers, timelines, and regulatory calendars to ensure accurate visibility into regulatory milestones and commitments.
Coordinate with external publishing vendors to ensure timely compilation and delivery of submission files.
Perform quality control (QC) review of submission outputs to ensure completeness, internal consistency, and technical readiness for submission.
Maintain official regulatory records and archives to support inspection and diligence readiness.
Track Health Authority correspondence and submission history to ensure visibility of follow-up commitments and support internal regulatory planning.
Identify and implement improvements to processes, tools, and documentation standards to enhance regulatory quality and efficiency.