Senior Global Labeling Strategy Lead

Parexel; Raleigh (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead and shape global labeling strategy across diverse therapy portfolios. You will own Target Product Label development, CCDS governance, and regional labeling strategies, collaborating with Regulatory, Clinical, Safety, Medical, and Commercial teams to ensure compliant, high-quality labeling throughout the product lifecycle.

The role requires strong medical/technical writing skills, extensive labeling experience across major

Qualifications

• 7-10+ years in biotech/pharmaceutical industry with 5-7+ years in global labeling/regulatory leadership.

Responsibilities

• Lead global labeling strategy across CCDS, US, EU, ROW and major markets.
• Own TPL development for early-phase assets.
• Develop labeling content for regulatory submissions and HA responses.
• Support ROW labeling assessments and CCDS alignment across regions.
• Communicate strategy and risks to leadership and project teams.
• Manage labeling team meetings and drive content decisions.
• Provide coverage during peak periods.

Skills

Leadership

Regulatory strategy

Cross-functional collaboration

Regulatory writing

Strategic thinking

Effective communication

Education

Bachelor’s degree in Life Sciences or related field

Advanced degree preferred (MSc, PhD, PharmD)

Tools

RIMS (Veeva)

eDMS (Veeva)

Apollo

Docubridge

Trackwise

Microsoft Office

SharePoint

Job description

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead and shape global labeling strategy across diverse therapy portfolios. You will own Target Product Label development, CCDS governance, and regional labeling strategies, collaborating with Regulatory, Clinical, Safety, Medical, and Commercial teams to ensure compliant, high-quality labeling throughout the product lifecycle.

The role requires strong medical/technical writing skills, extensive labeling experience across major