Global Regulatory Labeling Strategy Lead

Parexel; Sacramento (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

Parexel seeks an experienced Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies, from early development through post-approval lifecycle.

You will own Target Product Label development, CCDS, and regional labeling strategies, and you will partner with Regulatory, Clinical, Safety, Medical, and Commercial functions to deliver compliant, high‑quality labeling documentation worldwide.

Qualifications

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• 7–10+ years in biotech/pharmaceutical industry; 5–7+ years in global labeling/regulatory with leadership responsibilities.
• Experience leading cross-functional teams and influencing stakeholders across diverse settings.
• Strong knowledge of global labeling regulations including vaccine development and registrations.
• CTD format experience; ownership of CCDS and global labeling updates.

Responsibilities

• Provide strategic leadership for global labeling activities across CCDS, US, EU, ROW, and other major markets.
• Lead TPL development for early-phase assets.
• Develop labeling content and ensure regulatory submission readiness.
• Support ROW labeling assessments and Health Authority responses.
• Interface with project teams to ensure consistent labeling processes and local compliance.

Skills

Leadership

Communication

Regulatory strategy

Medical writing

Cross-functional teamwork

Project management

Education

Bachelor's in Life Sciences

MSc/PhD/PharmD preferred

Tools

RIMS

eDMS

Trackwise

Promomats

GLAMS

Microsoft Office

Job description

Parexel seeks an experienced Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies, from early development through post-approval lifecycle.

You will own Target Product Label development, CCDS, and regional labeling strategies, and you will partner with Regulatory, Clinical, Safety, Medical, and Commercial functions to deliver compliant, high‑quality labeling documentation worldwide.