Global Regulatory Labeling Leader - Strategy & Content

Parexel; Frankfort (KY); Vor Ort; USD 150.000 - 190.000; Vollzeit

Zusammenfassung

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies. You will own CCDS, TPL, and regulatory submissions while coordinating with Regulatory, Clinical, Safety, Medical, and Commercial teams.

You will drive governance, partner with global stakeholders, and ensure compliant, high-quality labeling documentation through the product lifecycle, including ROW strategies and cross-market approvals.

Qualifikationen

• Leadership and consensus-building experience.
• Strong written and verbal communication with regulatory audiences.
• Experience in medical/technical writing for labeling documents.
• Labeling experience across CCDS, US, EU, UK, and ROW markets; oncology/rare disease experience is a plus.
• Experience with TPL work for early development programs.

Aufgaben

• Provide global labeling strategy leadership across CCDS, US, EU, ROW, and major markets.
• Develop labeling content and ensure regulatory compliance for submissions (MAAs, NDA/BLA/MAA).
• Lead TPL development for early-phase assets; own CCDS labeling updates.
• Coordinate health authority responses and ROW labeling assessments.
• Present strategies and plans to Global Labeling Committee and senior management.

Kenntnisse

Global labeling strategy

Cross-functional leadership

Regulatory strategy

Medical writing

Regulatory submissions

Ausbildung

Bachelor’s degree in Life Sciences

MSc/PhD/PharmD preferred

Tools

Veeva RIMS

Veeva eDMS

Trackwise

Microsoft Office

Jobbeschreibung

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy across a diverse portfolio of therapies. You will own CCDS, TPL, and regulatory submissions while coordinating with Regulatory, Clinical, Safety, Medical, and Commercial teams.

You will drive governance, partner with global stakeholders, and ensure compliant, high-quality labeling documentation through the product lifecycle, including ROW strategies and cross-market approvals.