US Regulatory Lead

amgen; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Amgen is seeking a US Regulatory Lead to drive regulatory strategy and execution across product lifecycles. You will oversee country regulatory activities, collaborate with cross-functional teams, and ensure compliant submissions and lifecycle management for Amgen’s oncology, inflammation, and rare disease portfolio.

Ideal candidates bring deep regulatory experience in the US, strong leadership and strategic planning skills, and a proven track record in shaping regulatory pathways to speed

Qualifications

• Experience leading US regulatory submissions and lifecycle management.
• Strong cross-functional collaboration and program leadership.
• Ability to interpret regulatory requirements and develop executable plans.

Responsibilities

• Lead US regulatory strategy and execution across product lifecycles.
• Coordinate with cross-functional teams to prepare submissions and maintain compliance.
• Oversee local regulatory activities for assigned Amgen products with medium complexity.

Skills

Regulatory affairs

Leadership

Strategic planning

Education

Bachelor's degree in life sciences

Job description

Career Category

Regulatory

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

US Regulatory Lead

What you will do

Let’s do this. Let’s change the world. US Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.

The Local Regulatory Representative (Manager) is assigned to one or more Amgen products, and plans and executes the Regulatory strategies for that product(s) in their country(ies). The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.

• Assist in aligning local regulatory