Global Regulatory Labeling Strategy Lead

Parexel; Boston (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Parexel seeks an experienced Senior/Global Regulatory Labeling Strategist to lead the global labeling strategy across a diverse portfolio, from early development through lifecycle management, blending regulatory science with medical writing excellence.

You will own Target Product Label development, CCDS governance, and regional labeling strategies, partnering with Regulatory, Clinical, Safety, and Commercial teams to deliver compliant, high‑quality labeling across US, EU, ROW and other major

Qualifications

• 7-10+ years in biotech/pharma with global labeling leadership.
• Experience leading cross-functional teams across geographies.
• Proven ability to author and govern CCDS.
• Strong knowledge of global labeling regulations.
• Delivery of major regulatory applications.

Responsibilities

• Lead global labeling strategy across CCDS and major markets.
• Own TPL development for early-phase assets.
• Prepare health authority responses and submissions.
• Govern labeling content and ensure regional label alignment.
• Communicate strategy to leadership and cross-functional teams.

Skills

Leadership

Communication

Medical writing

Regulatory labeling

Cross-functional collaboration

Strategic thinking

Problem solving

Regulatory knowledge

Project management

Attention to detail

Education

Life Sciences degree

Advanced degree preferred

Tools

RIMS (Veeva)

eDMS (Veeva)

Trackwise

CTD expertise

Microsoft Office

Job description

Parexel seeks an experienced Senior/Global Regulatory Labeling Strategist to lead the global labeling strategy across a diverse portfolio, from early development through lifecycle management, blending regulatory science with medical writing excellence.

You will own Target Product Label development, CCDS governance, and regional labeling strategies, partnering with Regulatory, Clinical, Safety, and Commercial teams to deliver compliant, high‑quality labeling across US, EU, ROW and other major