Global Regulatory Labeling Strategy Director

IQVIA LLC; Durham (NC); On-site; USD 104,000 - 289,000; Part time

Job summary

IQVIA seeks an Associate Director of Regulatory Labeling Strategy in the US on a 6‑month contract to accelerate labeling for new products in US, EU, UK, and ROW. You will lead early labeling content, ensure regulatory compliance and coordinate with global teams to support NDA/BLA/MAA timelines.

Qualified candidates bring 10+ years in pharma, 7+ years in regulatory labeling, and strong leadership and medical writing skills. Global labeling exposure for vaccines or rare diseases is a plus.

Qualifications

• BA/BS in a scientific discipline required; Master's or PhD preferred.
• 10+ years of experience in the pharmaceutical industry.
• 7+ years of experience in Regulatory labeling.
• Strong knowledge of current global regulations (vaccines a plus).
• Solid experience with CTD format and regulatory filings.
• Exceptional written and oral communication skills.
• Experience dealing with broad stakeholders at all levels.
• Delivers labeling for major NDA/BLA/MAA.

Responsibilities

• Lead global labeling strategy across CCDS, US, EU and ROW.
• Develop and maintain labeling knowledge and communicate requirements.
• Lead Target Product Label development for early-phase assets.
• Develop labeling content and format for regulatory submissions.
• Ensure new labeling text meets regulatory requirements.
• Support ROW labeling assessments and HA responses.
• Coordinate with teams to ensure labeling process consistency.
• Present strategy, risks and plans to leadership teams.

Skills

Global labeling

Regulatory strategy

Team leadership

Medical writing

CTD format

FDA/EMA knowledge

Education

BA/BS in scientific discipline

MS/PhD preferred

Job description

IQVIA seeks an Associate Director of Regulatory Labeling Strategy in the US on a 6‑month contract to accelerate labeling for new products in US, EU, UK, and ROW. You will lead early labeling content, ensure regulatory compliance and coordinate with global teams to support NDA/BLA/MAA timelines.

Qualified candidates bring 10+ years in pharma, 7+ years in regulatory labeling, and strong leadership and medical writing skills. Global labeling exposure for vaccines or rare diseases is a plus.