Associate Director, Regulatory Affairs

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About this role

Associate Director, Regulatory Affairs South San Francisco, CA The Opportunity: 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, facilitating interactions with Health Authorities, and ensuring successful execution of regulatory plans. The Impact You'll Have : - Represent Regulatory Affairs for assigned programs, providing regulatory leadership and guidance, identifying regulatory risks and developing mitigation strategies, and leading the execution of regulatory plans. - Contribute to the development and implementation of regulatory strategies for assigned programs in alignment with corporate objectives and regulatory requirements. - Conduct regulatory research to provide recommendations for various regulatory scenarios, proactively identify risks, and inform regulatory strategies. - 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

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