Sr. Regulatory Affairs Professional, Global TA

Role: Senior Regulatory Affairs Professional supporting global R&D initiatives within Johnson & Johnson's Innovative Medicine division, focusing on diverse drug development programs and marketed products. Responsibilities include participating in global/regional regulatory teams, advising on regulatory strategies, preparing agency meetings, managing communication with health authorities, reviewing clinical trial and submission documents, and ensuring compliance with regulatory requirements. The role involves understanding regional regulatory environments, supporting inspections/audits, and contributing to lifecycle management. Qualifications: Bachelor’s in a scientific discipline with 6+ years (or PharmD/PhD with 2+ years, or Master’s with 3+ years) of relevant experience, with knowledge of drug development processes. Preferred: Experience in regulated industries, regulatory submission expertise in US/EMA guidelines, cross-therapeutic experience, health authority interactions, and project management skills. Skills: Strong communication, analytical reasoning, strategic thinking, and regulatory compliance. High-Value specifics include supporting early to late-stage development and lifecycle activities across multiple therapeutic areas in a fast-paced, innovative environment. Location options are Spring House, PA, Raritan, NJ, or Titusville, NJ, with a focus on cross-functional collaboration and regulatory submission management.