US Regulatory Lead

Amgen seeks a US Regulatory Lead to manage regulatory strategies and submissions for assigned pharmaceutical products across development, registration, and lifecycle stages. This remote role involves coordinating with regulatory agencies, cross-functional teams, and global partners to ensure compliance with US and corporate standards.

Responsibilities

• Develop and execute regulatory strategies for assigned products in compliance with FDA and corporate standards
• Manage US regulatory submissions including marketing applications and lifecycle maintenance activities
• Serve as primary contact with FDA and regulatory agencies for assigned products
• Create and maintain country-specific product labeling and promotional material approvals
• Monitor regulatory environment and communicate policy changes impacting Amgen to internal teams

Requirements

• Regulatory affairs experience managing product submissions and lifecycle management
• Knowledge of US FDA requirements and regulatory submission processes
• Strong cross-functional collaboration and stakeholder management skills
• Experience with regulatory strategy development and execution
• Familiarity with clinical development and marketing authorization processes
• Ability to monitor and interpret regulatory guidance and legislative changes