Japan Regulatory Strategy Manager

📍 Japan Tokyo, Japan·🏢 On-site

Responsibilities

Proactively lead to develop regulatory strategies and/or mitigate regulatory risks across RA Japan and/or across Amgen Lead process standardization/simplification to improve efficiency in regulatory processes Consistently demonstrate Amgen leadership behaviors Influence developing global regulatory strategies so that Japan development strategies are aligned.

requirements and strong interpersonal skills with ability to influence and engage.
Qualifications Basic Bachelor’s degree and 10+ years of directly related experience including 5+ years of
experience in Regulatory Affairs Preferred Advanced degree preferred In-depth regulatory
experience Knowledge of Japan legislation and regulations relating to medicinal products Knowledge of drug development Scientific/Technical Excellence Teamwork Communication skills both oral and written Ability to understand and communicate scientific/clinical information Knowledge and Skills Ability to lead effective teams Ability to work in matrix environments including cross-functional and global teams Ability to work under minimal direction with a medium degree of autonomy Analytical skills to evaluate
Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives Understanding of regulatory activities and how they affect projects and processes Ability to understand and communicate scientific and clinical information Organizational, communication, and time management skills needed to manage multiple assignments and processes Communication skills in English (TOEIC score ≥860 desirable) Native level Japanese Computers: Microsoft Outlook, Word, Excel,

Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career