Regulatory Labeling Associate Director (Remote Eligible)
Vertex Pharmaceuticals · Boston, MA
RegulatoryFull-time$162k–$242kCompany career page
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Role summary
Regulatory Labeling Associate Director will lead global product labeling strategy and execution across markets, managing compliance with regulatory requirements and overseeing labeling governance. The role involves developing core datasheets and market-specific labels while collaborating with senior stakeholders on regulatory strategy.
What they're looking for
- Bachelor's degree, preferably in life sciences
- 8+ years regulatory affairs experience in global labeling or equivalent
- Specialized knowledge of FDA, EMA, and other global regulatory labeling requirements
- Advanced ability to develop and apply regulatory labeling frameworks
- Proficiency with emerging technologies including AI-driven tools
- Strong project planning, prioritization, and cross-functional leadership skills
- Deep understanding of compliance and operational labeling requirements
What you'll be doing
- Ensure compliance with labeling governance requirements and associated business processes
- Lead label working groups and represent labeling at senior governance meetings
- Develop and maintain global product labeling including CCDS, USPI, and regional market labels
- Advise stakeholders on regulatory requirements and manage health authority interactions regarding labeling
- Contribute to labeling strategy and oversee responses to regulatory questions and inspections
Privacy & handoff
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