Manager Global Regulatory Scientist, Regulatory Affairs
This role involves leading regulatory strategy and submissions for global health authorities, including drafting applications like INDs, CTAs, and NDAs/MAAs. The candidate will provide expert regulatory guidance across product development stages, support agency interactions, respond to queries, and ensure compliance with FDA, ICH, and other global regulations. With a focus on oncology and combination products, the position requires strategic input, cross-functional collaboration, and lifecycle management across pharmaceuticals, devices, and biologics.