US Regulatory Lead — Shape Global Strategy & Compliance

Amgen SA; United States; Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Competitive benefits

Flexible work models

Stock-based incentives

Retirement plan

Job summary

Amgen is seeking a US Regulatory Lead to drive regulatory strategy for Amgen molecules in the United States. You will manage local filings, ensure compliance with FDA requirements, and collaborate with cross‑functional teams to optimize development and lifecycle plans.

The role requires advanced degrees and experience in US regulatory affairs, with leadership responsibilities mentoring junior staff and coordinating with global teams.

Qualifications

• Basic Qualifications include a Doctorate, or a Master’s with 3+ years US Regulatory experience, or a Bachelor’s with 5+ years US Regulatory experience.
• Experience leading regulatory submissions and interactions with FDA.
• Strong teamwork, communication and project management skills.

Responsibilities

• Lead local regulatory strategies for Amgen products in the US.
• Plan and manage regulatory submissions and lifecycle maintenance.
• Collaborate with global teams to align regulatory activities.

Skills

Regulatory leadership

FDA regulatory experience

Team mentoring

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Job description

Amgen is seeking a US Regulatory Lead to drive regulatory strategy for Amgen molecules in the United States. You will manage local filings, ensure compliance with FDA requirements, and collaborate with cross‑functional teams to optimize development and lifecycle plans.

The role requires advanced degrees and experience in US regulatory affairs, with leadership responsibilities mentoring junior staff and coordinating with global teams.