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

Role: Principal Scientist in CMC Regulatory Affairs for drug-device combination products, supporting regulatory strategies, submissions, and lifecycle management. Responsibilities: develop and execute global regulatory strategies, review submission content for clinical and marketing applications, provide assessments for manufacturing and product changes, and facilitate health authority interactions. Requirements: Bachelor's in a scientific, engineering, or related discipline; minimum 8 years in Regulatory Affairs, Quality, or Product Development within regulated healthcare sectors; experience with pharmaceutical, biotech, medical device, or combination products; strong knowledge of global regulatory standards and cross-functional collaboration skills. Preferred: expertise in drug-device development, global regulatory submissions, and understanding of frameworks like FDA 21 CFR Part 4 and EU MDR; RAC certification is advantageous. High-Value: focus on combination products, including biologics and pharmaceuticals; support across pre-approval and post-market phases; involvement in global regulatory strategy, risk assessment, and compliance; cross-functional teamwork with R&D, manufacturing, and regulatory teams. Work setup: hybrid in the US (NJ or PA); travel approximately 10% domestically or internationally.