ResponsibilitiesServe as Global Regulatory Lead (GRL) for early and late-stage West Coast Hub (WCH) programs; own global regulatory strategy across the full product lifecycle (early development through registration, post-approval, and indication expansion).
Own and continuously evolve the global regulatory strategy as programs advance, increase in complexity, and expand across indications and geographies.Provide WCH portfolio-level regulatory leadership (development sequencing, indication prioritization, and long-term regulatory positioning).
Recommend expansion, modification, or curtailment of development strategies based on scientific evidence, regulatory intelligence, and evolving health authority expectations.Provide scientific and regulatory guidance and serve as a recognized technical expert/thought leader.Lead complex cross-functional regulatory workstreams (Clinical Development, PO&T, Clinical Operations, Pharmacovigilance, Medical Affairs, Commercial, and external p...