Doctorate degree or extensive regional regulatory experience
Knowledge of international clinical trial applications
Experience with marketing authorization lifecycle management
The International Regulatory Lead Manager provides strategic regulatory leadership for Amgen products across international countries
Job Summary
The International Regulatory Lead Manager provides strategic regulatory leadership for Amgen products across international countries.
This role involves optimizing product development and securing regulatory approvals through collaboration with global and local teams.
The position requires directing label submission strategies and managing negotiations to ensure successful product registration and lifecycle management.
Matching Summary
The International Regulatory Lead Manager provides strategic regulatory leadership for Amgen products across international countries.
Skills & Requirements
Must-have
Doctorate degree or extensive regional regulatory experience
Knowledge of international clinical trial applications
Experience with marketing authorization lifecycle management
Understanding of oncology product regulations
Ability to develop international regulatory strategies
Nice-to-have
Conflict resolution and beneficial outcome development
Cultural awareness across international borders
Strong negotiation and influencing skills
High degree of initiative and self-motivation
Effective communication with virtual global teams
Key Requirements
Doctorate degree OR 8+ years relevant experience
Master's degree AND 9+ years relevant experience
Bachelor's degree AND 10+ years relevant experience
Regional regulatory experience in biotechnology/oncology