Global Labelling Strategy Lead

Biopharma Careers; Washington; On-site; USD 95,000 - 193,000; Full time

Job summary

Viatris is seeking a Senior Manager, Core Labeling Strategy to provide global regulatory labeling leadership for existing and new products. You will develop, maintain, and implement labeling in compliance with regulatory requirements, including CCDS and patient information, across markets.

The role requires 7–10 years in labeling, experience with global labeling programs, and collaboration with Regulatory, Medical, Safety, and Commercial teams to align strategy and submissions.

Qualifications

• Bachelor's degree in Science, Medicine, Pharmacy, or related field with 7–10 years’ experience, including significant labeling experience.
• Experience in development and maintenance of global core labeling (CCDS) and major market labeling (USPI, EU SmPC).
• Experience supporting regulatory submissions (NDA/BLA/MAA) preferred.
• Advanced degree (MSc, PharmD, PhD) advantageous but not required.

Responsibilities

• Accountable for management and delivery of labeling activities across assigned products/portfolio.
• Leads development, preparation, review, and approval of global labeling documentation (TPL, CCDS, Core Patient Information) and territorial labeling (EU SmPC, USPI).
• Leads or supports development of labeling strategy in partnership with Global Regulatory.
• Establishes cross-functional partnerships to ensure proactive labeling development.

Skills

Regulatory labeling

Cross-functional leadership

Global labeling

Regulatory strategy

Communication

Education

Bachelor's degree in Science/Medicine/Pharmacy

Advanced degree advantageous (MSc/PharmD/PhD)

Job description

Viatris is seeking a Senior Manager, Core Labeling Strategy to provide global regulatory labeling leadership for existing and new products. You will develop, maintain, and implement labeling in compliance with regulatory requirements, including CCDS and patient information, across markets.

The role requires 7–10 years in labeling, experience with global labeling programs, and collaboration with Regulatory, Medical, Safety, and Commercial teams to align strategy and submissions.