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.
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer.
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
biotechnology and/or oncology products
regulatory mechanisms
Nice-to-have
resolve conflicts
cultural awareness and sensitivity
negotiation and influencing skills
Key Requirements
Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience.