Global Labeling Strategy Director

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

Job summary

IQVIA seeks a Director of Regulatory Labeling Strategy to lead global labeling efforts for CCDS, US, EU, UK, and ROW, including vaccines and oncology projects. The role targets early development programs and lifecycle labeling across major markets.

You will drive CTD submissions, coordinate with cross-functional teams, and mentor a labeling team while ensuring regulatory timeliness and high-quality content for NDA/BLA/MAA pathways.

Qualifications

• 10+ years of experience in the pharmaceutical industry with 7+ years in Regulatory labeling.
• Strong knowledge of current global regulations, including vaccines development regulations.
• Exceptional written and oral communication.
• Experience dealing with a broad range of stakeholders.
• Delivery of labeling for major NDA/BLA/MAA filings.

Responsibilities

• Provide labeling strategy across CCDS, US, EU, Rest of World (ROW) and other major markets.
• Develop and maintain current knowledge of labeling regulations and communicate requirements to stakeholders.
• Lead the Target Product Label (TPL) development for early-phase assets.
• Develop labeling content, format and accountability for regulatory submissions (MAAs) and related supplements and amendments.
• Support ROW labeling assessments against the CCDS and preparation of Health Authority responses.
• Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
• Communicate regulatory labeling strategy, risks, and plans to leadership and teams.
• Provide input to the end-to-end labeling process.
• Lead labeling team meetings and drive strategic discussions.

Skills

Leadership

Communication

Medical writing

Regulatory labeling

Cross-functional collaboration

Stakeholder management

Strategic thinking

Program management

Education

Bachelor's degree in a scientific discipline

Master's degree

PhD

Job description

IQVIA seeks a Director of Regulatory Labeling Strategy to lead global labeling efforts for CCDS, US, EU, UK, and ROW, including vaccines and oncology projects. The role targets early development programs and lifecycle labeling across major markets.

You will drive CTD submissions, coordinate with cross-functional teams, and mentor a labeling team while ensuring regulatory timeliness and high-quality content for NDA/BLA/MAA pathways.