The role provides regulatory leadership for the development, registration, and lifecycle management of Amgen molecules in international countries
Job Summary
The role provides regulatory leadership for the development, registration, and lifecycle management of Amgen molecules in international countries.
The incumbent will develop international regulatory strategies, optimize product development mechanisms, and support local label strategies aligned with global standards.
This position requires building effective relationships across global, regional, and local organizations to ensure seamless execution of regulatory activities.
Matching Summary
The role provides regulatory leadership for the development, registration, and lifecycle management of Amgen molecules in international countries.
Skills & Requirements
Must-have
International regulatory strategy development
Product registration and lifecycle management
Global clinical trial submission planning
Labeling strategy and negotiation
Cross-functional team collaboration
Nice-to-have
Process improvement initiative experience
Strong negotiation and influencing skills
Cultural awareness across international borders
Knowledge management and query triaging
Key Requirements
Doctorate degree with 6 years experience OR Master's with 8 years OR Bachelor's with 10 years
In-depth knowledge of regional countries legislation and regulations
Experience with CTA/MA documentation and agency commitments