Associate Director, Regulatory Affairs, North American Regional Leader

Role: Associate Director, Regulatory Affairs, North American Regional Leader, focusing on regulatory strategies for innovative oncology products, particularly in interventional oncology aimed at tumor treatment. Responsibilities include establishing North American content requirements, managing NDA/BLA/IND submissions, serving as the primary FDA contact, leading responses to health authority questions, and overseeing label negotiations and regulatory documentation. The role also involves strategic planning for submissions, participating in health authority interactions, and providing regulatory input on development documents. Qualifications: Bachelor's in a scientific discipline with 8+ years of regulatory experience, or advanced degrees with proportionally less experience; strong knowledge of US FDA regulations, clinical development, and lifecycle management of regulatory submissions. Preferred skills include oncology experience, familiarity with combination products, biomarker development, and cross-functional collaboration, along with leadership capabilities and excellent communication skills. The position may require 10% domestic and potential international travel. The role is based in Spring House, PA or Raritan, NJ, within Johnson & Johnson's Innovative Medicine Regulatory Affairs group.