Manager - International Regulatory Lead

About the role

The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to

What you'll do

• Optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country…
• Provide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals
• Develop the international regulatory strategy and contribute to Global regulatory plans
• Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments)
• Support and advise on the local label strategy and alignment to cCDS/reference label

What you need

• Compliance
• Any graduate