Director, Global Regulatory Labeling Strategy

IQVIA LLC; Durham (NC); 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 global markets. Based in the US, the role demands a forward-looking regulatory professional who can anticipate labeling challenges and deliver compliant content for CCDS, US, EU, and ROW across vaccines, oncology and rare diseases.

The 6-month contract requires leadership in TPL development, regulatory submissions (MAAs), and cross-functional collaboration with senior management to align labeling

Qualifications

• BA/BS in a scientific discipline required; advanced degree preferred.
• 10+ years of experience in the pharmaceutical industry.
• 7+ years of experience in Regulatory labeling.
• Strong knowledge of current global regulations, including vaccine development regulations and registrations pathways.
• Experience delivering labeling for at least one major application (NDA/BLA/MAA/JNDA).

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 industry standards for labeling and communicate requirements to stakeholders as needed.
• 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.
• Ensure that new labeling text meets regulatory labeling requirements.
• Support ROW labeling assessments against the CCDS and preparation of Health Authority (HA) responses.
• Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
• Effectively communicate the regulatory labeling strategy, risks, mitigation strategies and overall plans to the Global Regulatory Science Leadership Team, Project Development Teams and senior management, as relevant.
• Provide input to the end-to-end labeling process.
• Ability to lead and manage labeling team meetings, driving strategic discussions and managing content.
• Provide coverage, as needed, on other products during peak periods or during absences of other team members.

Skills

Global labeling strategy

Regulatory labeling

Medical writing

Project leadership

Regulatory submissions

Stakeholder communication

CTD knowledge

FDA/HA timelines

Education

BA/BS in scientific discipline

Master’s or PhD preferred

Job description

IQVIA is seeking a Director of Regulatory Labeling Strategy to support new programs in the US and global markets. Based in the US, the role demands a forward-looking regulatory professional who can anticipate labeling challenges and deliver compliant content for CCDS, US, EU, and ROW across vaccines, oncology and rare diseases.

The 6-month contract requires leadership in TPL development, regulatory submissions (MAAs), and cross-functional collaboration with senior management to align labeling