Associate Director, Regulatory Affairs

Role Summary

Associate Director, Regulatory Affairs at Maze Therapeutics. Lead regulatory strategy and execution for clinical-stage programs, manage global regulatory activities, prepare submissions, and support Health Authority interactions.

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.

Qualifications

• Bachelor's degree required; advanced degree in life sciences preferred.
• 7+ 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; NDA/MAA experience 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

Skills

• Regulatory strategy and submission management
• Cross-functional collaboration
• Health Authority engagement and briefing document drafting
• Regulatory documentation quality and timelines
• Strong written and verbal communication

Education

• Bachelor's degree; life sciences advanced degree preferred

Additional Requirements

• Travel requirements not specified
• None beyond standard regulatory affairs expectations