Associate Director, Regulatory Affairs (Oncology & Rare Disease)
Amgen(5 months ago)
About this role
Senior regulatory leader at Amgen responsible for Japan regulatory strategy for oncology and rare disease within Global Regulatory Affairs and Strategy (GRAAS). The role leads the Local Regulatory Affairs (Japan) team and coordinates with regional and global stakeholders and Japanese health authorities to align local regulatory objectives with global development and commercialization plans.
Required Skills
- Regulatory Strategy
- Labeling
- Team Leadership
- HA Interaction
- Compliance
- Stakeholder Management
- Clinical Knowledge
- Vendor Management
- Japanese Communication
- English Communication
Qualifications
- Doctorate Degree
- Master’s Degree
- Bachelor’s Degree
- 4 Years Managerial Experience
- TOEIC ≥860 (Desirable)
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
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