Amgen is seeking a qualified candidate to lead regulatory strategy for obtaining and maintaining clinical trial and marketing licenses in Japan
Job Summary
Amgen is seeking a qualified candidate to lead regulatory strategy for obtaining and maintaining clinical trial and marketing licenses in Japan.
The role requires developing and implementing regulatory strategies aligned with global goals while proactively influencing the approval process to serve more patients.
Candidates will act as the primary interface with Japanese health authorities like PMDA and MHLW to facilitate drug approvals and maintain compliance.
Matching Summary
Amgen is seeking a qualified candidate to lead regulatory strategy for obtaining and maintaining clinical trial and marketing licenses in Japan.
Skills & Requirements
Must-have
10+ years Regulatory Affairs experience
5+ years Japan regulatory experience
Native level Japanese language skills
PMDA and MHLW interaction expertise
New Drug Application (NDA) filing knowledge
Nice-to-have
Advanced degree in life sciences
TOEIC score of 860 or higher
Experience with Orphan Drug Applications
Strong influence on global strategy
Matrix environment leadership skills
Key Requirements
Bachelor's degree required
10+ years directly related experience
5+ years Japan regulatory experience
Native level Japanese proficiency
English communication skills (TOEIC ≥860 desirable)