Global Regulatory Labeling Strategist: Lead & Influence

Parexel; Pierre (SD); On-site; USD 140,000 - 210,000; Full time

Job summary

Parexel seeks an experienced Senior/Global Regulatory Labeling Strategist to lead labeling strategy across CCDS, US, EU and ROW for a diverse portfolio. You will drive TPL development, CCDS ownership, and regulatory submissions, while guiding cross‑functional teams and ensuring compliant, high‑quality labeling across global markets.

Strong medical writing and leadership are essential. You will interact with Regulatory Science Leadership, Clinical, Safety, Medical, and Commercial teams, shaping

Qualifications

• Experience leading global labeling strategy and governance.
• Proven medical/technical writing capability.
• Strong leadership and cross‑functional collaboration skills.
• Labeling experience across CCDS, US, EU, ROW markets.
• Experience with TPL in early development programs.
• Ability to meet regulatory timelines for major submissions.

Responsibilities

• Lead global labeling strategy across CCDS, US, EU, ROW and other major markets.
• Develop and own TPL for early‑phase assets and labeling content for submissions.
• Support ROW labeling assessments and Health Authority responses.
• Interface with project teams to ensure CCDS consistency and local compliance.
• Communicate regulatory labeling strategy and risk mitigation to leadership.
• Lead labeling team meetings and manage content delivery.
• Provide coverage on other products during peak periods.

Skills

Leadership

Communication

Medical writing

Regulatory labeling

Cross-functional collaboration

Strategic thinking

Problem solving

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred

Tools

Veeva RIMS

Veeva eDMS

Apollo

Docubridge

Trackwise

Microsoft Office

SharePoint

Adobe Acrobat

Job description

Parexel seeks an experienced Senior/Global Regulatory Labeling Strategist to lead labeling strategy across CCDS, US, EU and ROW for a diverse portfolio. You will drive TPL development, CCDS ownership, and regulatory submissions, while guiding cross‑functional teams and ensuring compliant, high‑quality labeling across global markets.

Strong medical writing and leadership are essential. You will interact with Regulatory Science Leadership, Clinical, Safety, Medical, and Commercial teams, shaping