Director, Global Regulatory Labeling Strategy

IQVIA; North Carolina; 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 and globally. This role targets swift labeling delivery for new products across markets including the US, EU, UK and Switzerland, on a six-month contract with potential extension.

You will lead global labeling strategy, develop TPL for early-phase assets, oversee CTD submissions, and coordinate cross-functional teams to ensure CCDS compliance and timely product approvals.

Qualifications

• BA/BS in a scientific discipline; Master’s or PhD preferred.
• 10+ years in pharma; 7+ years in regulatory labeling.
• Strong knowledge of global regulations including vaccines.
• CTD format experience and regulatory filings.
• Excellent written and oral communication.
• Experience dealing with broad stakeholders internally and externally.
• Delivery of labeling for at least one major NDA/MAA/JNDA.

Responsibilities

• Provide global labeling strategy across CCDS, US, EU, ROW, and other major markets.
• Develop and maintain knowledge of labeling regulations and communicate requirements.
• Lead the Target Product Label (TPL) development for early-phase assets.
• Develop labeling content, format and accountability for regulatory submissions and amendments.
• Support ROW labeling assessments and Health Authority responses.
• Interface with teams to ensure CCDS compliance and local labeling.
• Communicate regulatory labeling strategy and risks to leadership.
• Provide input to end-to-end labeling processes.
• Lead labeling team meetings and drive strategic discussions.
• Provide coverage during peak periods or absences.

Skills

Leadership

Communication

Collaboration

Medical/Technical writing

Labeling experience

Regulatory strategy

Project coordination

Flexibility

Education

BA/BS in scientific field

MS/PhD preferred

Tools

CTD format knowledge

Regulatory submissions

Job description

IQVIA is seeking a Director of Regulatory Labeling Strategy to support new programs in the US and globally. This role targets swift labeling delivery for new products across markets including the US, EU, UK and Switzerland, on a six-month contract with potential extension.

You will lead global labeling strategy, develop TPL for early-phase assets, oversee CTD submissions, and coordinate cross-functional teams to ensure CCDS compliance and timely product approvals.