Principal Scientist, CMC Regulatory Affairs - Combination Products (1 of 2)

Role: Principal Scientist, CMC Regulatory Affairs - Combination Products, providing regulatory expertise for drug-device combination products involving both pharmaceutical and medical device components. Responsibilities include developing regulatory strategies for clinical, marketing, and lifecycle activities; preparing submission content; supporting health authority interactions; and ensuring compliance with global regulations such as FDA and EU MDR. The role involves cross-functional collaboration within Johnson & Johnson's Innovative Medicine and MedTech units, contributing to product development, registration, and lifecycle management. Qualifications: minimum of a Bachelor's in a scientific or engineering discipline, with 8+ years of relevant experience in regulatory affairs, quality, or product development within regulated healthcare environments. Preferred skills include experience with combination product development, global regulatory submissions, and knowledge of relevant frameworks (FDA, EU MDR). The position requires strong scientific, analytical, and communication skills, with ability to influence cross-functional teams. Travel is approximately 10%. High-value specifics: focus on combination products, drug-device regulation, lifecycle management, and global regulatory strategy. Work setup: hybrid roles in New Jersey or Pennsylvania.