・Responsible for leading the development, alignment, and implementation of Japan regulatory strategy for assigned projects and programs across all stages of development (pre-Phase 1 through commercial), integrating local regulatory requirements, global development objectives, business priorities, and emerging regulatory trends.
・ Provide end-to-end leadership for all aspects of regulatory submissions relevant to assigned projects or programs in Japan, establishing the submission strategy, driving cross-functional execution, resolving issues and competing priorities, and ensuring alignment with global project plans and Japan business objectives.
・ Lead the strategy, preparation, and conduct of necessary meetings and other interactions with Japanese Health Authorities for assigned projects, aligning cross-functional positions, articulating the company’s regulatory rationale, and translating authority feedback into clear actions and strategic recommendations.
・ Identify, assess, and communicate regulatory risks and opportunities for assigned projects or programs; develop mitigation and escalation strategies, and influence project and functional leadership decisions by clarifying implications for development, approval, launch, and life cycle management in Japan.
・Provide recommendations that not only comply with regulatory requirements, but also carefully weigh the risks and benefits of pursuing innovative approaches and propose solutions that go beyond conventional precedents.