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. Focuses on supporting development and approval of novel tumor-targeted therapies, including biologics or combination products. Responsibilities: develop NA regulatory content plans aligned with global dossiers (BLA/NDAs, INDs/CTAs), serve as US FDA point of contact, lead regulatory responses, guide submission strategy, manage routine post-approval activities, review labeling and regulatory documents, and facilitate cross-functional collaboration. Qualifications: Bachelor's degree in a scientific discipline, 8+ years of relevant regulatory experience (advanced degrees preferred), with deep knowledge of US and global regulatory processes, particularly in clinical drug development and lifecycle management. High-value specifics: oncology focus, experience with biologics or combination therapies, involvement in IND/ NDA submissions, and regulatory interactions with health authorities. Work setup: based in Spring House, PA or Raritan, NJ, with ~10% domestic travel; potential international travel.