This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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.
Job Responsibility
Provide regulatory leadership & expertise for International countries for one or more Amgen products
Collaborate 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
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
Build effective relationships and communication paths across global, regional, local and functional organizations
Enable efficiencies and seamless execution across the international countries
Contribute to process improvement projects, as assigned
Requirements
Doctorate degree and 6 years of directly related experience
OR Master's degree and 8 years of directly related experience
OR Bachelor's degree and 10 years of directly related experience
Nice to have
8-13 years of experience with degree and in-depth regulatory experience and/or related to the region
In-depth knowledge of regional countries legislation and regulations relating to medicinal products