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 teams in triaging health authority queries.
This position requires building effective relationships across global, regional, and local organizations to ensure seamless execution of regulatory plans.
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
Strong negotiation and influencing skills
Cultural awareness across international borders
Process improvement initiative experience
Knowledge of orphan drug designations
Experience with expedited regulatory pathways
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 legislation and regulations relating to medicinal products
Directly related experience in international regulatory environment