Position Summary

The Senior Regulatory Affairs Program Manager leads complex cross-functional regulatory initiatives from strategy through execution, ensuring products meet global regulatory requirements and are delivered in alignment with business objectives and launch timelines. This role partners closely with R&D, Clinical, CMC, Manufacturing, and Commercial teams to develop and implement regulatory strategies, manage submission activities and timelines, and support successful product approvals and lifecycle management worldwide. The position also serves as a key regulatory liaison, driving cross-functional alignment, proactive risk management, and regulatory excellence across the organization.

Essential Functions