Associate Director, Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate Director, Regulatory Affairs based in United States. The Associate Director, Regulatory Affairs will support global regulatory activities across innovative oncology development programs. This role provides regulatory leadership at both molecule and study levels, helping shape strategies and guide submissions throughout the clinical development lifecycle. You will collaborate closely with clinical, technical, and cross-functional teams to prepare high-quality regulatory submissions and manage interactions with health authorities. The position offers significant exposure to FDA and international regulatory processes, including clinical trial applications, INDs, BLA and MAA filings, and health authority meetings. You will also help identify regulatory risks, coordinate responses, and ensure commitments and timelines remain on track. This is an opportunity to contribute to programs addressing significant unmet medical needs while working in a fast-paced, collaborative, and globally oriented environment.

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