Principal Scientist, CMC Regulatory Affairs - Combination Products role will provide CMC (Chemistry, Manufacturing, and Controls) regulatory subject matter expertise for drug-device combination products and related device constituent parts involved in the preparation or administration of drugs. This role may support pre-approval and post-approval programs, synthetic or biologic products, and products in any therapeutic area. The Principal Scientist will develop and execute regulatory strategies for assigned combination product programs, submissions, Health Authority interactions, and lifecycle management activities. This individual may serve as a core member of the combination product development team and may serve as an ad hoc member of the CMC team (or Value Chain team for post-approval programs), and Global Regulatory Team. This role will also support successful development, registration, and lifecycle management of combination products globally. This individual will provide subject matter expertise regarding global combination product and global medical device regulatory requirements and is expected to consult with other medical device regulatory experts within Johnson & Johnson Innovative Medicine or Johnson & Johnson MedTech, as needed. The role will apply in-depth regulatory and scientific knowledge to address complex issues involving one or more related disciplines, establish operational plans for assigned responsibilities, provide guidance to technical and cross-functional colleagues, and contribute to business results through effective regulatory execution.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
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