Found Description
**Role Description**
**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**
**- optimize product development and regulatory approvals in International countries**
**- develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management.**
**Roles & Responsibilities**
**Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.**
**Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans).**
**...
**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**
**- optimize product development and regulatory approvals in International countries**
**- develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management.**
**Roles & Responsibilities**
**Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.**
**Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans).**
**...
Ready to Apply?
Submit your application for Manager - International Regulatory Lead at Amgen
Apply Now