Sr. Regulatory Affairs Professional, Global TA

Role: Senior Regulatory Affairs Professional, Global Therapeutic Area supporting Johnson & Johnson's Innovative Medicine division. Primary objectives include advising on global/regional regulatory strategies, preparing submissions, and ensuring compliance across multiple therapeutic areas and product stages. Responsibilities encompass participating in regulatory team meetings, liaising with health authorities, reviewing clinical and regulatory documents, and contributing to lifecycle management activities. Qualifications require a bachelor’s in a scientific field plus 6+ years of industry or academic experience, or advanced degrees with fewer years. Preferred skills include experience with US/EMA regulatory processes, responding to health authority requests, cross-functional collaboration, and diverse therapeutic area knowledge. High-value details involve work on drug development programs from early to late stages, including marketed products, with emphasis on regulatory submission, approval processes, and compliance within a complex, fast-paced environment. The role may involve interactions with health authorities and requires strong interpersonal, communication, and project management skills. Work setup is in Raritan, NJ, Spring House, PA, or Titusville, NJ, with no specified travel requirements.