Director, Regulatory Labeling Strategy (Remote-Eligible)

Job title: Director, Regulatory Labeling Strategy (Remote-Eligible)

About the Role

The Regulatory Labeling Director will lead the strategic development of global labeling for one or more marketed products, overseeing the creation and maintenance of labeling across therapeutic areas, including Company Core Data Sheets (CCDS) and local labeling for major markets. This role will be accountable for labeling governance and related business processes.

What You'll Do

• Ensure labeling governance compliance and manage related business processes.
• Lead label working groups and represent labeling at product-specific global regulatory teams and senior governance meetings.
• Plan and lead development and maintenance of global product labeling for one or more products, including CCDS and regional labeling for US, EU, GB, CA.
• Lead labeling strategy and advise stakeholders on regulatory labeling requirements; oversee interactions with health authorities for labeling questions, negotiations, and inspections.
• Conduct research on labeling precedent, regulations, policies to properly advise on impacts and outcomes.
• May lead one or more therapeutic areas and be responsible for strategic development and lifecycle management of labeling for that area, including Target Labeling Profiles.

What We're Looking For

• Bachelor’s degree with typically 10 years of experience in regulatory affairs in global labeling or related discipline.
• Experience leading labeling development and regulator negotiation activities for an initial marketing application or major indication expansion.
• Ability to synthesize complex concepts and communicate at all levels, with specialized depth of knowledge of global labeling requirements.
• Advanced ability to develop and apply knowledge of regulatory labeling frameworks and to plan, prioritize, and execute labeling-related projects.
• Strong attention to detail and a quality-driven mindset; understanding of compliance and operational requirements for labeling.
• Demonstrates ability to adopt emerging technologies and maintain a continuous learning mindset to strengthen decision-making.

Nice to Have

• Familiarity with AI, automation, competitive intelligence and changes in regulatory environment as they relate to labeling.
• Experience leveraging emerging technologies to enhance regulatory labeling processes.

Compensation & Benefits

• Pay Range: $185,600 - $278,400 USD. This role is eligible for an annual bonus and annual equity awards; overtime may be available where permitted by law.
• Vertex Total Rewards include medical, dental, and vision benefits, generous paid time off, educational assistance, student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k), and more.
• Flex Designation: Remote-Eligible with options for Remote, Hybrid, or On-Site per policy.