Strategic CMC Regulatory Lead - Hybrid

Shionogi Inc. in Florham Park, NJ is seeking a Senior Manager, Regulatory Affairs CMC to lead strategic CMC regulatory activities under the guidance of the Senior Director. You will coordinate with R&D, QA, manufacturing, and commercial teams to align regulatory plans with development timelines and ensure timely FDA/EMA submissions. The role requires a scientific degree with at least five years in regulatory affairs focused on CMC, plus strong communication and cross‐functional collaboration.