Regulatory Labeling Manager

• Lead and coordinate US labeling process management activities across assigned products, ensuring labeling deliverables are planned, developed, reviewed, approved, and implemented in accordance with established processes and regulatory timelines.
• Serve as the point of contact for assigned products, working cross-functionally with Regulatory Leads/Strategists, Labeling Strategy, Artwork, Operations, Supply Chain, Publishing, Regulatory Promotions, vendors, and other relevant stakeholders.
• Manage US labeling activities supporting initial submissions, supplemental submissions, Health Authority negotiations, approvals, and post-approval implementation.
• Support labeling activities during FDA/Health Authority negotiations, coordinating labeling changes and associated artwork activities resulting from HA feedback and ensuring alignment across impacted stakeholders.
• Coordinate the creation, review, approval, and lifecycle management of US labeling artwork projects, ensuring appropriate source text, regulatory requirements, timelines, and stakeholder inputs are incorporated.
• Coordinate Structured Product Labeling (SPL) activities, including initiation of SPL requests, review/QC of SPL packages, resolution of identified issues, and handoff of finalized SPL packages to appropriate regulatory stakeholders for submission.
• Partner with Regulatory and Labeling Strategy colleagues during Health Authority questions and negotiations to assess labeling impacts, coordinate required updates, manage artwork implications, and support timely execution of regulatory responses.
• Facilitate cross-functional alignment on labeling strategy, implementation plans, risks, dependencies, timelines, and deliverables, escalating significant risks or issues as appropriate.
• Ensure labeling activities are executed in compliance with applicable Amgen procedures, regulatory requirements, quality standards, and established labeling processes.
• Support labeling process improvements, simplification initiatives, digital solutions, metrics, and operational excellence activities to improve quality, compliance, efficiency, and Right First Time (RFT) performance.
• Provide guidance and subject matter expertise to cross-functional stakeholders regarding US labeling processes, requirements, roles, and operational considerations.

Basic Qualifications

Bachelor’s degree or Master’s degree with 9 to 12 years of directly related experience in Regulatory Affairs, regulatory labeling, labeling process management, labeling operations, artwork management, regulatory operations, or a related pharmaceutical or biotechnology function.

Equivalent combinations of education and relevant experience may also be considered

Preferred Qualifications

• Experience with US FDA pharmaceutical or biologic labeling and associated regulatory processes.
• Experience supporting Health Authority submissions, questions/negotiations, and post-approval implementation.
• Knowledge of US labeling deliverables such as prescribing information, patient labeling, package component labeling/artwork, and SPL.
• Experience with labeling artwork development and implementation.
• Experience with RIM or comparable regulatory information management systems.
• Experience managing multiple products, submissions, and competing priorities simultaneously.
• Experience working with external labeling/artwork vendors and global cross-functional teams.
• Understanding of labeling quality, compliance, change management, and Right First Time principles.
• Ability to work independently, exercise sound judgment, identify risks, and drive issues through resolution.
• Familiarity with inspection readiness expectations, SOP compliance, documentation standards, quality-controlled processes, and audit-ready record maintenance.

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