Reg Affairs Dir (Drug Development Strategy)

IQVIA · Tokyo, Japan

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Role summary

IQVIA seeks a Director of Drug Development Strategy to lead integrated pharmaceutical development advisory services in Japan. The role involves developing comprehensive development strategies, supporting executive decision-making, and contributing to the growth of the RADDS Japan business unit.

What they're looking for

10+ years of pharmaceutical development, regulatory strategy, clinical development, or consulting experience
Advanced expertise in drug development strategy and development plan formulation
Practical experience leading clinical development or clinical development strategy initiatives
Deep understanding of Japan's regulatory environment including PMDA
Experience leading complex strategic consulting projects or cross-functional development initiatives
Knowledge of TPP, CDP, indication prioritization, endpoint strategy, and benefit-risk evaluation
Strong communication and facilitation skills with executive and senior stakeholder audiences

What you'll be doing

Develop and advise on integrated drug development strategies for pharmaceutical and biotechnology clients
Lead formulation of Target Product Profile, Clinical Development Plans, and clinical evidence strategies
Advise on indication prioritization, endpoint strategy, development sequencing, and global regulatory approaches
Support PMDA consultation strategy, regulatory interactions, risk assessment, and inquiry response planning
Lead executive workshops, strategy meetings, advisory boards, and governance discussions with clients

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Date posted5 days ago

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