Global Labeling Strategy Director - Remote

Lifelancer Ltd; United States; Remote; USD 215,000 - 359,000; Full time

Job summary

IQVIA seeks a Director of Regulatory Labeling Strategy to lead global labeling for CCDS, US, EU, and ROW. This role focuses on early and lifecycle labeling, coordinating with project teams to ensure regulatory readiness and timely submissions.

The ideal candidate has 10+ years in pharma with 7+ in regulatory labeling, strong strategic thinking, and proven leadership in cross-functional environments. Remote role with 6-month contract potential extension.

Qualifications

• BA/BS degree in scientific discipline required; advanced degree preferred.
• 10+ years of experience in the pharmaceutical industry.
• 7+ years of experience in Regulatory labeling.
• Strong knowledge of global labeling regulations.
• Experience with CTD format and regulatory filings.
• Exceptional written and oral communication skills.
• Delivery of labeling for at least one major application.

Responsibilities

• Global labeling strategy across CCDS, US, EU, ROW, and other markets.
• Develop and maintain current labeling knowledge and communicate requirements.
• Lead Target Product Label (TPL) development for early-phase assets.
• Develop labeling content for regulatory submissions and amendments.
• Support ROW labeling assessments and Health Authority responses.
• Coordinate with teams to ensure CCDS compliance and consistency.
• Communicate strategy, risks, and plans to leadership and teams.
• Provide coverage on other products during peak periods.

Skills

Leadership

Communication

Medical writing

Labeling experience

TPL development

Regulatory labeling

FDA/EMA knowledge

Strategic thinking

Stakeholder management

Education

BA/BS in science

Master’s or PhD preferred

Job description

IQVIA seeks a Director of Regulatory Labeling Strategy to lead global labeling for CCDS, US, EU, and ROW. This role focuses on early and lifecycle labeling, coordinating with project teams to ensure regulatory readiness and timely submissions.

The ideal candidate has 10+ years in pharma with 7+ in regulatory labeling, strong strategic thinking, and proven leadership in cross-functional environments. Remote role with 6-month contract potential extension.