Associate Global Labeling Strategy Director

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

Job summary

IQVIA seeks an Associate Director of Regulatory Labeling Strategy to support new programs in the US and internationally. This 6-month contract role focuses on leading global labeling for CCDS, US, EU, UK and ROW while coordinating with project teams and senior management.

The ideal candidate brings 10+ years in pharma and 7+ in regulatory labeling, with CTD experience and strong communication skills to drive labeling for major regulatory submissions and approvals.

Qualifications

• BA/BS in a scientific discipline required.
• 10+ years in the pharmaceutical industry.
• 7+ years in Regulatory labeling.
• Strong knowledge of global regulations (including vaccines).
• CTD format and content regulatory filings experience.
• Exceptional written and oral communication.
• Stakeholder management across internal and external partners.
• Delivery of labeling for major applications (NDA/BLA/MAA/JNDA).

Responsibilities

• Provide global labeling strategy across CCDS, US, EU, ROW and other markets.
• Maintain up-to-date labeling knowledge and communicate requirements to stakeholders.
• Lead Target Product Label development for early-phase assets.
• Develop labeling content and ensure regulatory submissions meet requirements.
• Support ROW labeling assessments and HA responses.
• Coordinate labeling processes with cross-functional teams and ensure CCDS alignment.
• Communicate strategy, risks, and plans to leadership groups.
• Contribute to end-to-end labeling process and oversight of meetings.
• Provide coverage during peak periods or absences.

Skills

Meeting facilitation

Leadership

Medical/technical writing

Global labeling knowledge

TPL work

Regulatory timelines

Integrity

Relationship building

Strategic thinking

Communication

Team collaboration

Flexibility

Education

BA/BS in a scientific discipline

Master's or PhD preferred

Job description

IQVIA seeks an Associate Director of Regulatory Labeling Strategy to support new programs in the US and internationally. This 6-month contract role focuses on leading global labeling for CCDS, US, EU, UK and ROW while coordinating with project teams and senior management.

The ideal candidate brings 10+ years in pharma and 7+ in regulatory labeling, with CTD experience and strong communication skills to drive labeling for major regulatory submissions and approvals.