Global Core Labelling Strategy Lead

1100 Mylan Pharmaceuticals Inc.; Washington, Northern (District of Columbia, KY); Hybrid; USD 78,000 - 152,000; Full time

Job summary

Viatris is seeking a Manager, Core Labeling Strategy to drive global core labelling development and maintenance across product lifecycles. The role requires leadership in CCDS and patient information, with collaboration across Regulatory, Medical, Safety, and Commercial teams to ensure compliant labelling for USPI, EU SmPC, and other markets.

The position emphasizes strategic labelling initiatives, adherence to SOPs, and proactive management of regulatory expectations, while representing Viatris

Qualifications

• Bachelor’s degree in Science, Medicine, Pharmacy, or related field with typically 3-5 years of experience, including significant labelling experience.
• Experience developing and maintaining global core labelling (e.g. CCDS) and major market labelling (e.g. USPI, EU SmPC).
• Experience supporting regulatory submissions (e.g. NDA/BLA/MAA) is preferred.

Responsibilities

• Supports management and delivery of labelling activities across assigned products/portfolio.
• Contributes to development, preparation, review, and approval of global labelling docs (TPL, CCDS, Core Patient Information) and territorial labelling (EU SmPC, USPI).
• Supports development of labelling strategy in partnership with Global Regulatory, ensuring alignment with regulatory strategy and business objectives.
• Leads labelling updates and development, evaluating data for scientific accuracy and regulatory acceptability.
• Chairs or contributes to Product Labelling Teams (PLTs) and escalates issues to the Global Labelling Committee (GLC).
• Reviews and approves promotional and non-promotional materials for CCDS alignment.

Skills

Regulatory labelling

Cross-functional collaboration

Communication skills

Presentation skills

Regulatory strategy

Education

Bachelor’s degree in Science/Medicine/Pharmacy

Advanced degree advantageous

Job description

Viatris is seeking a Manager, Core Labeling Strategy to drive global core labelling development and maintenance across product lifecycles. The role requires leadership in CCDS and patient information, with collaboration across Regulatory, Medical, Safety, and Commercial teams to ensure compliant labelling for USPI, EU SmPC, and other markets.

The position emphasizes strategic labelling initiatives, adherence to SOPs, and proactive management of regulatory expectations, while representing Viatris