Regulatory Intelligence Manager - FSP | Regulatory Intelligence Manager - FSP

Job Summary

This pivotal role involves monitoring, analyzing, and communicating global regulatory developments impacting a world-leading biotech client's pipeline and operations. The Regulatory Intelligence Manager will track regulatory changes, guidance documents, and policy trends across major markets (FDA, EMA, PMDA) and stakeholders (ICH, EU Commission). Day-to-day tasks include assessing the implications of these updates on development programs, ensuring proactive regulatory strategy alignment, and interacting closely with cross-functional teams like Regulatory Affairs, Clinical, Quality, and Legal. A core part of the role is creating and distributing internal newsletters, alerts, and briefing documents, maintaining a centralized knowledge repository, and utilizing regulatory intelligence tools and generative AI concepts. The ideal candidate must have a Bachelor's degree in life sciences, 5+ years of specialized experience in biopharmaceutical regulatory intelligence, and perfect command of English, coupled with strong analytical and project management skills.