US Regulatory Lead: Strategy, Submissions & Compliance

Amgen Inc. (IR); Thousand Oaks (CA); Hybrid; USD 113,000 - 153,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models where possible

Job summary

Amgen in the United States seeks a US Regulatory Lead to plan and execute regulatory strategies for Amgen products, ensuring compliance with local requirements while aligning with global plans. This role leads local submissions and interfaces with regulatory agencies to support lifecycle management.

This position requires a Doctorate or advanced degree with regulatory experience, and a track record in leadership and cross-functional collaboration within regulatory affairs.

Qualifications

• Doctorate or Master’s degree with regulatory experience required.
• Experience directly managing people and/or leadership roles required.
• Regulatory submissions experience and interaction with regulatory agencies (FDA) preferred.

Responsibilities

• Lead local regulatory strategy and execution for Amgen products in the US.
• Plan and manage local regulatory submissions in accordance with corporate standards and local requirements.
• Advise global teams on local regulatory implications and ensure regulatory product compliance.

Skills

Regulatory knowledge

Strong communication

Teamwork

Negotiation and influencing

Education

Doctorate degree

Master’s degree + 3 years US Regulatory experience

Bachelor’s degree + 5 years US Regulatory experience

Associate’s degree + 10 years US Regulatory experience

High school diploma / GED + 12 years US Regulatory

Job description

Amgen in the United States seeks a US Regulatory Lead to plan and execute regulatory strategies for Amgen products, ensuring compliance with local requirements while aligning with global plans. This role leads local submissions and interfaces with regulatory agencies to support lifecycle management.

This position requires a Doctorate or advanced degree with regulatory experience, and a track record in leadership and cross-functional collaboration within regulatory affairs.