Senior Global Regulatory Labeling Strategy Lead

Parexel; Saint Paul (MN); On-site; USD 140,000 - 190,000; Full time

Job summary

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies. You will own TPL development for early‑phase assets, CCDS, regional labeling strategies, health authority responses, and labeling support for major regulatory applications.

In this high‑visibility role, you will define labeling strategy, lead governance, partner with global stakeholders, and ensure compliant, high‑quality labeling documentation throughout

Qualifications

• Experience leading global labeling programs and governance.
• Strong medical/technical writing and regulatory knowledge.
• Proven ability to influence cross‑functional teams across geographies.
• Familiarity with CCDS, US/EU labeling requirements, and major markets.
• Experience with CTD formats and regulatory filings.

Responsibilities

• Provide strategic leadership for global labeling activities across CCDS, US, EU, ROW.
• Own Target Product Label (TPL) development for early assets.
• Lead health authority responses and regulatory submissions.
• Govern labeling governance with cross‑functional teams.
• Mentor labeling team members and ensure compliant documentation.

Skills

Leadership

Regulatory strategy

Communication

Cross-functional

Strategic thinking

Project management

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred (MSc/PhD/PharmD)

Tools

RIMS (Veeva)

eDMS (Veeva)

Trackwise/Change Management

Microsoft Office/SharePoint

Job description

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies. You will own TPL development for early‑phase assets, CCDS, regional labeling strategies, health authority responses, and labeling support for major regulatory applications.

In this high‑visibility role, you will define labeling strategy, lead governance, partner with global stakeholders, and ensure compliant, high‑quality labeling documentation throughout