Manager, Core Labeling Strategy

Responsibilities

• Provide global regulatory labeling expertise to ensure product information for existing and new products is developed and maintained in compliance with regulatory requirements.
• Lead the development and maintenance of Core Labeling, including CCDS and associated patient information.
• Support the development of labeling strategy in partnership with Global Regulatory to ensure alignment with business objectives.
• Contribute to Target Product Labeling (TPL), competitive labeling analysis, and regulatory precedent assessments.
• Establish strong cross-functional partnerships with Regulatory, Medical, Safety, and Clinical teams.
• Review and approve promotional and non-promotional materials for alignment with CCDS and applicable codes.
• Chair or contribute to Product Labeling Teams (PLTs) and escalate key issues to the Global Labeling Committee (GLC).

Requirements

• Bachelor’s degree in Science, Medicine, Pharmacy, or a related field.
• 3-5 years of experience in pharmaceutical labeling.
• Demonstrated experience in the development and maintenance of global core labeling (e.g., CCDS) and major market labeling (e.g., USPI, EU SmPC).
• Highly developed interpersonal, presentation, and communication skills with the ability to influence in a matrixed environment.

Preferred Qualifications

• Advanced degree such as MSc, PharmD, or PhD.
• Experience supporting regulatory submissions (e.g., NDA, BLA, or MAA).
• Experience in TPL development and competitive labeling benchmarking.

About the Company

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands. Our mission is to empower people worldwide to live healthier at every stage of life by providing access to high-quality medicines to approximately 1 billion patients annually.