Amgen's shared mission is to serve patients living with serious illnesses by researching, manufacturing, and delivering innovative medicines
Job Summary
Amgen's shared mission is to serve patients living with serious illnesses by researching, manufacturing, and delivering innovative medicines.
The US Regulatory Lead will plan and execute regulatory strategies for assigned products, manage local submissions, and act as the point of contact with regulatory agencies.
Amgen offers a comprehensive employee benefits package including a Retirement and Savings Plan, group medical, dental and vision coverage, and award-winning time-off plans.
Matching Summary
Amgen's shared mission is to serve patients living with serious illnesses by researching, manufacturing, and delivering innovative medicines.
Salary
Base: 112,744.00USD - 152,536.00 USD; Bonus/Equity: Discretionary annual bonus program, Stock-based long-term incentives; Benefits: Comprehensive employee benefits package, Retirement and Savings Plan, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts
Skills & Requirements
Must-have
US Regulatory Affairs
regulatory strategy execution
product lifecycle management
regulatory submissions
health authority interactions
Nice-to-have
collaborative culture
science-based approach
passion for challenges
cultural awareness and sensitivity
Key Requirements
Doctorate degree OR Master’s degree and 2 years of directly related experience OR Bachelor’s degree and 4 years of directly related experience OR Associate’s degree and 8 years of directly related experience OR High school diploma / GED and 10 years of directly related experience
Knowledge of Regulatory principles
In-depth regulatory experience in the applicable country(ies)
In-depth knowledge of country(ies) legislation and regulations