Labeling Strategist

Amgen · Remote

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RegulatoryRemoteFull-timeCompany career page

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Role summary

Amgen seeks a Labeling Strategist to develop and maintain product labeling documents and drive global labeling strategy across the product lifecycle. This regulatory role ensures safe and effective use of medicines for patients and healthcare providers worldwide, managing complex labeling processes for assigned therapeutic areas.

What they're looking for

Doctorate degree with 2+ years related experience, or Master's degree with 4+ years, or Bachelor's degree with 6+ years
Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, and industry standards
Knowledge of global labeling regulatory requirements, standards, and processes
Strong technical writing and project management skills with demonstrated planning and execution ability
Team leadership capability with interpersonal, negotiation, and conflict resolution skills
Proficiency in Microsoft Office Suite and Regulatory Information Management systems
Preferred: life science or medicine degree; pharmaceutical regulatory affairs or product labeling experience

What you'll be doing

Chair Labeling Working Groups and lead presentations to Cross-Functional Executive Labeling Board meetings
Lead development and maintenance of core labeling documents including Core Data Sheets, patient information leaflets, and US Prescribing Information
Represent labeling on product-specific global regulatory teams and inform decisions impacting portfolio assets
Manage medium to high complexity compounds from labeling perspective and provide strategic guidance on regulatory requirements
Supervise direct reports, support career development, and assist with Health Authority queries and annual regulatory submissions

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