Director, Labeling Strategy
IQVIA · Durham, NC
RegulatoryFull-time$129k–$359kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
IQVIA seeks a Director of Regulatory Labeling Strategy for a 6-month contract role based in Durham, North Carolina. The position supports global labeling strategy for new pharmaceutical products across major markets including the US, EU, UK, and Switzerland.
What they're looking for
- BA/BS in scientific discipline; Master's or PhD preferred
- 10+ years pharmaceutical industry experience
- 7+ years regulatory labeling experience
- Expertise in global regulations, vaccine development pathways, and CTD format
- Delivery of labeling for at least one major regulatory application (NDA/BLA/MAA)
- Exceptional written and oral communication skills
- Experience with rare diseases, oncology, or vaccines labeling desirable
What you'll be doing
- Develop and execute global labeling strategy across CCDS, US, EU, ROW, and major markets
- Lead Target Product Label development for early-phase assets and regulatory submissions
- Maintain current knowledge of labeling regulations and communicate requirements to stakeholders
- Interface with project teams to ensure labeling consistency and local compliance
- Communicate regulatory labeling strategy, risks, and mitigation plans to leadership and 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.