Global Regulatory Labeling Strategy Director

IQVIA LLC; Durham (NC); On-site; USD 129,000 - 359,000; Full time

Job summary

IQVIA is seeking a Director of Regulatory Labeling Strategy to support new programs in the US. This 6-month contract role involves delivering labeling for global markets, including the US, EU and ROW, with leadership in labeling strategy and CTD/TPL development across multiple programs.

The candidate will lead labeling activities, coordinate with global teams, and ensure regulatory requirements are met for NDA/MAA/JNDA submissions and related supplements.

Qualifications

• Global labeling experience across CCDS, US, EU, ROW and other major markets.
• Ability to lead Target Product Label (TPL) development for early-phase assets.
• Experience preparing regulatory submissions (MAAs) and supplements/amendments.

Responsibilities

• Provide labeling strategy for global markets and communicate requirements to stakeholders.
• Lead and manage labeling team meetings and strategic discussions.
• Ensure labeling text meets regulatory requirements and timelines.

Skills

Global labeling experience

Regulatory strategy leadership

FDA/EMA/MHRA communications

Medical/technical writing

Cross-functional collaboration

TPL development

Education

BA/BS in scientific discipline

Master’s or PhD preferred

Tools

CTD format

Job description

IQVIA is seeking a Director of Regulatory Labeling Strategy to support new programs in the US. This 6-month contract role involves delivering labeling for global markets, including the US, EU and ROW, with leadership in labeling strategy and CTD/TPL development across multiple programs.

The candidate will lead labeling activities, coordinate with global teams, and ensure regulatory requirements are met for NDA/MAA/JNDA submissions and related supplements.