Director, Regulatory Labeling Strategy (Remote-Eligible)

Vertex Pharmaceuticals · Boston, MA

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RegulatoryFull-time$186k–$278kCompany career page

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Role summary

Vertex Pharmaceuticals seeks a Director of Regulatory Labeling Strategy to lead global labeling development and lifecycle management for marketed pharmaceutical products. This remote-eligible role requires expertise in regulatory compliance, health authority interactions, and strategic oversight across major markets including the US, EU, and Canada.

What they're looking for

Bachelor's degree and 10+ years regulatory affairs experience in global labeling
Expertise in FDA, EMA, and other global regulatory labeling requirements
Demonstrated success leading labeling development for initial marketing applications or major indication expansions
Advanced knowledge of CCDS development and lifecycle management across regions
Strong attention to detail with quality-driven mindset and compliance understanding
Proficiency with structured content management, eLabeling technologies, and AI-driven labeling tools
Ability to communicate complex regulatory concepts clearly across organizational levels

What you'll be doing

Lead label working groups and represent labeling at product-specific global regulatory teams and governance meetings
Develop and maintain global product labeling including CCDS and regional prescribing and patient information
Advise stakeholders on regulatory labeling requirements and oversee health authority interactions and negotiations
Conduct research on labeling precedents, regulations, and policies to inform labeling strategy
Manage strategic development and lifecycle labeling for assigned therapeutic areas, including target labeling profiles

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Date posted4 days ago

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