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

Role: Principal Scientist, CMC Regulatory Affairs - Combination Products, specializing in global regulatory strategies for drug-device combination products within Johnson & Johnson's Innovative Medicine division. Objectives include supporting pre-approval and post-approval programs across therapeutic areas, developing regulatory strategies, and ensuring compliance with global regulations. Responsibilities encompass providing expert interpretation of global regulatory requirements, reviewing submission content for clinical and marketing applications, assessing manufacturing and device changes, and guiding Health Authority interactions. Collaborating with cross-functional teams such as development, quality, and regulatory, the role also involves monitoring emerging regulations and supporting lifecycle management activities. Requirements: Bachelor's degree in a scientific or engineering discipline, with at least 8 years' experience in Regulatory Affairs, Quality, or Product Development within regulated healthcare environments, including pharma, biotech, or medical devices. Strong knowledge of drug-device combination product development, global regulatory frameworks (FDA, EU MDR), and experience supporting global submissions and device registration are preferred. Additional qualifications include excellent communication, analytical, and organizational skills, with a regulatory affairs certification (RAC) considered a plus. The position is hybrid and based across multiple U.S. locations, with approximately 10% travel expected.