Career Category
Regulatory
Job Description
The Regulatory Labeling Manager, part of Global Labeling Compliance (GLC) is responsible for the planning, coordination, and execution of US regional labeling activities across the product lifecycle. The role serves as a key operational interface between Regulatory, Labeling Strategy, Artwork, Operations, Supply Chain, Publishing, external vendors, and other cross-functional stakeholders to enable timely and compliant delivery of US labeling.
The US LPM manages labeling activities from submission readiness through Health Authority (HA) negotiations, approval, artwork development, implementation, and post-approval activities. The role requires strong regulatory labeling knowledge, project leadership, independent decision-making, and the ability to manage multiple complex products and priorities simultaneously.
Key Responsibilities
- 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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