Labeling Strategy Director
IQVIA · Durham, NC
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Role summary
IQVIA seeks a Director of Regulatory Labeling Strategy to develop and execute global labeling strategies for early-phase pharmaceutical assets across major markets including the US, EU, and UK. The role involves leading target product label development, ensuring regulatory compliance, and coordinating with cross-functional teams on submissions and amendments. This is a 6-month contract position based in Durham, North Carolina.
What they're looking for
- Bachelor's degree in scientific discipline; Master's or PhD preferred
- 10+ years pharmaceutical industry experience
- 7+ years regulatory labeling experience
- Proficiency with CTD format and regulatory filing content
- Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA)
- Strong knowledge of global regulations including vaccine development pathways
- Exceptional written and oral communication skills
What you'll be doing
- Provide labeling strategy support across CCDS, US, EU, ROW, and major markets
- Lead Target Product Label development for early-phase assets
- Develop labeling content and ensure regulatory compliance for MAAs and supplements
- Support ROW labeling assessments and Health Authority response preparation
- Communicate regulatory strategy, risks, and plans to leadership and project teams
Privacy & handoff
This role links to IQVIA's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.