Regulatory Affairs Mgr
Core
Develop and execute regulatory strategies to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan, interfacing with local authorities (MHLW/PMDA) and aligning with global strategy.
Role type
Senior Regulatory Strategy Manager (Japan)
Builds
Regulatory submissions (NDAs, CTNs, Orphan Drug Applications), briefing documents, and local labels for Amgen products in Japan.
Domain
Biotechnology / Pharmaceutical Regulatory Affairs (Japan)
Required skills
Japan regulatory requirements expertise, drug development lifecycle knowledge, regulatory submission preparation, cross-functional collaboration, strategic planning, compliance management, stakeholder engagement, risk mitigation, process standardization, scientific/clinical information interpretation
Preferred skills
Advanced degree, deep in-depth regulatory experience, knowledge of Japan medicinal product legislation, ability to lead teams, matrix environment navigation, autonomous problem solving, TOEIC score ≥860, native level Japanese
Technologies
Microsoft Outlook, Word, Excel, PowerPoint
Responsibilities
Develop and implement Japan regulatory strategy aligned with global plans; lead preparation of regulatory submissions (NDAs, CTNs, etc.); act as primary interface with MHLW and PMDA; collaborate with clinical study operations for local planning; ensure local labels comply with regulations; monitor national legislation and engage with trade associations; support compliance monitoring and auditing.
Seniority
Senior, hands-on IC with strategic influence