US Regulatory Lead — Flexible Work Model & Impact

Amgen Inc. (IR); Northern (KY); Hybrid; USD 180,000 - 230,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Retirement plan

Job summary

Amgen in the United States is seeking a US Regulatory Lead to develop and execute regulatory strategies for Amgen products. The role involves planning submissions, lifecycle management, and ensuring compliance with local and global standards.

You will partner with cross-functional teams across development, clinical operations, and market access to align regulatory plans with corporate objectives. You will act as the primary liaison with FDA and other agencies, guide labeling, and manage urgent

Qualifications

• Experience leading regulatory teams and projects.
• Strong knowledge of US regulatory principles and FDA processes.
• Proven ability to manage submissions and labeling changes.

Responsibilities

• Develop and execute regulatory strategies for Amgen products.
• Plan and manage local regulatory submissions and lifecycle maintenance.
• Coordinate labeling development and ensure local compliance.
• Interact with regulatory agencies and provide strategic input to global teams.
• Review promotional materials for regulatory clearance.
• Mentor Local Regulatory Representatives and support process improvements.

Skills

Leadership

Regulatory knowledge

Regulatory submissions

Communication skills

Teamwork

Education

Doctorate degree in Regulatory Science

Master’s degree in life sciences

Bachelor’s degree in a life science

Job description

Amgen in the United States is seeking a US Regulatory Lead to develop and execute regulatory strategies for Amgen products. The role involves planning submissions, lifecycle management, and ensuring compliance with local and global standards.

You will partner with cross-functional teams across development, clinical operations, and market access to align regulatory plans with corporate objectives. You will act as the primary liaison with FDA and other agencies, guide labeling, and manage urgent