US Regulatory Lead

Amgen · Remote

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RegulatoryRemoteFull-timeCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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