Global Labelling Strategy Director

Viatris; Washington; On-site; USD 112,000 - 236,000; Full time

Job summary

Viatris seeks an experienced Director of Core Labeling Strategy to lead global labelling governance, developing CCDS and patient information, ensuring compliance across regulatory requirements.

The role guides Target Product Labelling, USPI and EU SmPCs, coordinates with Product Labeling Teams and Global Medical, and interfaces with senior management to align strategy with lifecycle management and major submissions.

Qualifications

• Minimum of a Bachelor’s degree in Science, Medicine or Pharmacy with 10 years regulatory experience.
• Experience in global labelling strategy and development (CCDS, USPI, EU SmPC).
• Experience developing labelling for NDA/BLA or MAA submissions preferred.
• Leadership experience with direct reports and cross-functional teams.

Responsibilities

• Lead global labelling process and CCDS development across portfolio.
• Prepare and approve global labelling docs (CCDS, USPI) and EU SmPCs.
• Drive labelling strategy with Regulatory in line with corporate goals.
• Chairs Product Labeling Teams and coordinates with cross-functional partners.

Skills

Regulatory labeling leadership

Global CCDS development

USPI & EU SmPCs knowledge

Cross-functional leadership

Education

Bachelor's degree in Science/Medicine/Pharmacy

Master's Degree/PharmD/PhD preferred

Job description

Viatris seeks an experienced Director of Core Labeling Strategy to lead global labelling governance, developing CCDS and patient information, ensuring compliance across regulatory requirements.

The role guides Target Product Labelling, USPI and EU SmPCs, coordinates with Product Labeling Teams and Global Medical, and interfaces with senior management to align strategy with lifecycle management and major submissions.