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Senior/Global Regulatory Labeling Strategist at Parexel - ApplyBlast

Senior/Global Regulatory Labeling Strategist

Parexel

4 days ago

3.9 on Glassdoor

Remote

Full Time

Senior

0 applicants

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About this role

Parexel is seeking an experienced Senior/Global Regulatory Labeling Strategist to shape global labeling strategy across a diverse portfolio of innovative therapies. This role involves leading complex labeling initiatives from early development through post-approval lifecycle management, ensuring compliant and high-quality documentation for global markets. The position requires strategic leadership, cross-functional collaboration, and hands-on ownership of Target Product Label development and regulatory submissions.

Responsibilities

Lead global labeling strategy and governance for diverse therapeutic portfolios
Develop and maintain Target Product Label and Company Core Data Sheets
Manage regulatory submissions and health authority responses across major markets