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Alpha-9 Oncology is seeking an Associate Director of Regulatory Affairs to join its Regulatory Affairs team and drive the development of its growing clinical oncology pipeline. Reporting to the VP of Regulatory Affairs, you will shape and execute global regulatory strategy, lead submission planning and execution, and manage interactions with health authorities across multiple programs.
In this hands-on role, you will plan and manage regulatory activities across clinical development programs with minimal supervision, including clinical, nonclinical, and CMC activities. You will develop and implement regulatory strategies that support efficient development and timely approvals globally. You will represent Regulatory Affairs on cross-functional project teams, providing regulatory guidance and supporting program strategy and decision-making. You will partner closely with Clinical, CMC, Nonclinical, and other functions to incorporate regulatory considerations into program planning and execution, and maintain current knowledge of FDA, EU, ICH, and other global regulatory requirements.
You will develop, communicate, and manage submission plans, timelines, and deliverables, proactively identifying and escalating risks. You will lead the preparation, review, and submission of regulatory materials including INDs, amendments, CTAs, annual reports, safety reports, meeting requests, briefing packages, and other US and international submissions. You will prepare and review regulatory documents and support health authority interactions. You will also ensure regulatory submissions and records are maintained in a compliant, organized, and inspection-ready state, and build scalable processes and systems that improve quality and streamline regulatory activities.
You bring an advanced degree in a scientific, pharmacy, or related discipline with 8+ years of relevant regulatory affairs experience in biopharmaceutical industry. You have strong experience supporting global drug development programs with hands-on experience across INDs, amendments, CTAs, and other clinical-stage regulatory submissions. You have experience developing and executing regulatory strategies and working directly with health authorities across US and international markets. You demonstrate strong understanding of FDA, ICH, EU, and other global regulatory requirements and their application to clinical development programs. You work effectively cross-functionally with Clinical, CMC, Nonclinical, and other teams. You have excellent written and verbal communication skills, strong organizational skills and attention to detail, and a collaborative, solutions-oriented approach.
