Associate Director, Regulatory Affairs, North American Regional Leader

Role: Associate Director, Regulatory Affairs, North American Regional Leader, overseeing regulatory strategies for oncology projects within Johnson & Johnson's Innovative Medicine division. Primary objectives include managing North American content requirements, leading interactions with US FDA, and developing regulatory submission strategies for BLA/NDAs, INDs, and supplements. Responsibilities encompass coordinating regulatory responses, managing routine submissions and post-approval commitments, and ensuring label development aligns with regulatory standards. The role also involves providing strategic regulatory input on clinical development documents and leading cross-functional teams during health authority interactions. Qualifications: Bachelor's degree in a scientific discipline with 8+ years of relevant regulatory experience, or advanced degrees with proportionally fewer years; strong understanding of clinical drug development, US FDA processes, and lifecycle management of regulatory submissions; experience with oncology, diagnostics, combination products, or biomarker development is highly preferred. Skills include strategic thinking, leadership, excellent communication, and cross-functional collaboration, with the ability to work across product types (pharma, devices, combo). The position requires approximately 10% domestic travel, with potential international travel. Work setup is based in Spring House, PA, or Raritan, NJ.