Regulatory Manager (Specialty)

Lead regulatory strategy execution for specialty drug approvals in Japan, collaborating with global teams to navigate complex stakeholder environments. Draft and implement regulatory strategies aligned with pharmaceutical lifecycle management, while leading approval applications and direct advisory engagements with regulatory authorities. Analyze regulatory challenges to propose actionable solutions and manage negotiation tactics during discussions with government bodies. Facilitate cross-border communication to ensure alignment on regulatory requirements and present domestic regulatory issues within a global context.