Director, Global Regulatory Strategy — Cardiometabolic

Regulatory Toolkit; United States; Remote; USD 196,000 - 265,000; Full time

Benefits offered by this job

Retirement plan

Medical benefits

Annual bonus

Flexible time-off

Job summary

Amgen is seeking a Director of Global Regulatory Affairs for Cardiometabolic Disorders in the United States. This leadership role will shape regulatory strategy across obesity and metabolic disease programs, coordinating with cross-functional teams to drive global submissions, pediatric considerations, and labeling decisions.

You will lead interactions with health authorities (FDA, EMA, PMDA, and others) and external partners, ensuring strategies reflect scientific complexity and risk–benefit

Qualifications

• Doctorate degree and 4 years of regulatory experience.
• OR Master’s degree and 7 years of regulatory experience.
• OR Bachelor’s degree and 9 years of regulatory experience.
• Preferred: 8–10+ years of global regulatory experience with obesity/metabolic diseases.

Responsibilities

• Provide strategic regulatory leadership for obesity/metabolic programs.
• Lead the Global Regulatory Team and cross-functional collaboration.
• Oversee global regulatory submissions and labeling updates.
• Engage with Health Authorities (FDA/EMA and others) and external partners.

Skills

Regulatory strategy

Leadership

Cross-functional

FDA/EMA interactions

Metabolic disease science

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Job description

Amgen is seeking a Director of Global Regulatory Affairs for Cardiometabolic Disorders in the United States. This leadership role will shape regulatory strategy across obesity and metabolic disease programs, coordinating with cross-functional teams to drive global submissions, pediatric considerations, and labeling decisions.

You will lead interactions with health authorities (FDA, EMA, PMDA, and others) and external partners, ensuring strategies reflect scientific complexity and risk–benefit