Head of Regulatory Affairs, Development – Biopharma

Role Overview Lead Japan Regulatory Affairs activities for development programs, from development through approval and lifecycle management, in collaboration with global and local stakeholders.

Key Responsibilities

Lead and develop the Japan Regulatory Affairs Development team, including coaching, mentoring, and performance management. Develop and execute Japan regulatory strategies aligned with global development plans. Lead interactions with Japanese Health Authorities, including PMDA and MHLW. Lead Japan NDA and supplemental application activities, including indication expansions and formulation changes.

Oversee preparation of Japan regulatory submissions, including CTD Module 1 and related documents, and manage the Health Authority review process through approval. Lead Japan labeling and electronic Package Insert (J-PI) activities, including Health Authority responses and review of promotional materials. Manage external regulatory vendors and contribute to SOP, process, and operational improvements.

Identify and manage regulatory risks and provide strategic advice to cross-functional project teams.

Requirements

Key Qualifications Extensive Regulatory Affairs experience, particularly in drug development and Japan regulations. Strong experience with PMDA/MHLW interactions and Japan regulatory submissions. Proven people leadership and cross-functional/global collaboration experience. Strong stakeholder management, communication, strategic thinking, and project/risk management skills.

Native-level Japanese and business-level English.