Remote Global Regulatory Lead – Inflammation & Rare Disease

Amgen Inc. (IR); Northern (KY); Hybrid; USD 190,000 - 257,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Job summary

Amgen Inc. (IR) in the United States is seeking a Global Regulatory Affairs Director for Inflammation and Rare Disease to lead the Global Regulatory Team and shape regulatory strategy across development and lifecycle management.

You will drive global filings, interact with agencies, and ensure compliant labeling while guiding product teams. The role requires advanced degrees and substantial biotech regulatory experience.

Qualifications

• Doctorate degree with regulatory experience in biotech or science.
• Master's degree with regulatory experience in biotech or science.
• Bachelor's degree with regulatory experience in biotech or science.

Responsibilities

• Develop global regulatory product strategy and lead GRTs.
• Represent Regulatory on product teams and governance bodies.
• Lead planning and execution of global regulatory filings (CTAs, marketing applications).
• Ensure alignment of data sheets with regulatory guidance and evidence.
• Communicate regulatory strategies across the organization and with agencies.

Skills

Team leadership

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Communication skills

Decision making under ambiguity

Negotiation

Education

Doctorate degree in a relevant field

Master's degree in life sciences

Bachelor's degree in a life science

Job description

Amgen Inc. (IR) in the United States is seeking a Global Regulatory Affairs Director for Inflammation and Rare Disease to lead the Global Regulatory Team and shape regulatory strategy across development and lifecycle management.

You will drive global filings, interact with agencies, and ensure compliant labeling while guiding product teams. The role requires advanced degrees and substantial biotech regulatory experience.