Descripción de la oferta
Overview
In this role you lead global regulatory strategies for priority programs from early development to registration and lifecycle management. You shape development plans, labels, and high-quality submissions while coordinating health authority engagements across regions. You mentor regulatory strategists to ensure consistency and excellence and contribute to external policy discussions. You work closely with cross-functional partners to align regulatory goals with business priorities.
ResponsabilidadesOwn global regulatory strategies and roadmaps aligned with therapeutic and commercial goalsLead preparation of major submissions, scientific advice, and clinical trial applications; coordinate health authority meetingsGuide cross-functional teams on regulatory expectations (CMC/Nonclinical/Clinical) and documentation standardsManage risk registers, mitigation plans, and lifecycle labeling negotiationsDevelop function capability through coaching, standards, and best practicesManage high-level interactions with Executive Management and stakeholders
Requisitos principales12–15+ years in Regulatory Affairs with global submission leadershipExperience advancing assets from early development through regulatory approval in the EU and USExpert knowledge of ICH and regional frameworks (US/EU/ROW)Exceptional communication, influence, and strategic thinkingExperience in dermatology, immunology, biologics or specialty medicines; familiarity with digital and AI tools; leadership experienceFluency in Englishexceptional communicationinfluencestrategic thinkingglobal regulatory submissionsHC authority engagementsCMC/Nonclinical/Clinical coordination
