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

Role: Principal Scientist, CMC Regulatory Affairs - Combination Products, providing expert regulatory guidance for drug-device combination products across pre- and post-approval stages. Responsibilities: develop and implement global regulatory strategies for combination products, including submissions, Health Authority interactions, and lifecycle management; review clinical trial and marketing applications; assess manufacturing and device changes; support regulatory compliance and process improvement initiatives; monitor evolving global regulations. Requirements: Bachelor’s degree in a scientific, engineering, or pharmaceutical discipline; at least 8 years’ experience in Regulatory Affairs, Quality, or Product Development within regulated healthcare sectors; strong knowledge of global regulatory frameworks for combination products, including FDA and EU standards; excellent communication and cross-functional collaboration skills. Preferred: advanced degrees (Master’s, PharmD, Ph.D); experience with biologic or pharmaceutical combination products; regulatory expertise in global submissions and interactions; RAC certification; familiarity with design control, risk management, and lifecycle activities for drug-device systems. High-Value: focus on combination products (drug-device), global regulatory strategy, lifecycle management, and cross-functional team engagement. Work setup: hybrid roles based in Raritan, Titusville, Spring House, or Horsham, NJ/PA; approximately 10% domestic/international travel.