The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products
Job Summary
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.
The role includes developing international regulatory strategy and providing regulatory support for in-country product registrations and life cycle management.
Matching Summary
The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products.
Skills & Requirements
Must-have
International regulatory environment
Clinical trial applications
Marketing authorizations
Product labelling for biotech/oncology
Regulatory principles and activities
Nice-to-have
Conflict resolution
Cultural awareness and sensitivity
Negotiation and influencing skills
Team-oriented approach
Key Requirements
Doctorate degree OR Master's degree and 3 years experience OR Bachelor's degree and 5 years experience OR Associate degree and 10 years experience OR High school diploma/GED and 12 years experience