Global Core Labeling Strategy Lead

Viatris; Washington (District of Columbia); On-site; USD 78,000 - 152,000; Full time

Job summary

Mylan Inc. and Viatris operate as a global healthcare company driving access to medicines.

The Manager, Core Labeling Strategy will provide global regulatory labelling leadership to develop and maintain Product Information across existing and new Viatris products, ensuring compliance with regulatory requirements. The role supports Core Labelling (including CCDS and patient information) and collaborates on Global Ad Promo, Medical/Commercial material reviews, and regulatory strategy across

Qualifications

• Bachelor's degree in Science, Medicine, Pharmacy, or related field with typically 3-5 years of 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 (NDA/BLA/MAA) preferred.
• Advanced degree (MSc, PharmD, PhD) is advantageous but not required.

Responsibilities

• Supports management and delivery of labelling activities across assigned products/portfolio.
• Contributes to development, preparation, review, and approval of global labelling documentation (e.g. TPL, CCDS, Core Patient Information) and territorial labelling (e.g. EU SmPC, USPI).
• Supports development of labelling strategy in partnership with Global Regulatory, ensuring alignment with overall regulatory strategy and business objectives.
• May contribute to development and maintenance of Target Product Labelling (TPL) to support early development, regulatory positioning, and cross-functional alignment.
• Establishes strong cross-functional partnerships with Regulatory Strategists, Medical, Safety, and Clinical teams to ensure proactive and effective labelling development.
• Leads labelling updates and development, critically evaluating supporting data to ensure scientific accuracy, clinical relevance, and regulatory acceptability.
• Assesses and reconciles deviations from Company Core Position (e.g. CCDS) and supports responses to Health Authority requests.
• Chairs or actively contributes to Product Labelling Teams (PLTs), ensuring appropriate cross-functional input. Escalates key issues to the Global Labelling Committee (GLC) as required.
• Maintains strong awareness of competitor labelling, evolving regulatory requirements, and external trends to inform labelling strategy.
• Manages complex regulatory and scientific labelling issues, balancing compliance, business needs, and risk.
• Contributes to interpretation and application of emerging regulatory guidelines impacting labelling.
• May represent Viatris in external forums (e.g. industry groups, EMA/FDA workshops).
• Reviews and approves promotional and non-promotional materials for alignment with CCDS and applicable codes and requirements.
• Reviews and advises on key scientific and regulatory documents (e.g. IB, protocols, CSR, PSURs, RMPs) as appropriate.
• Provides labelling expertise in cross-functional and regulatory team discussions.
• Performs other labelling-related duties as assigned.

Skills

Regulatory labeling

Global labeling

Cross-functional teamwork

Education

Bachelor's degree in Science/Medicine/Pharmacy

MSc/PharmD/PhD advantageous

Tools

NDA/BLA/MAA submissions

Job description

Mylan Inc. and Viatris operate as a global healthcare company driving access to medicines.

The Manager, Core Labeling Strategy will provide global regulatory labelling leadership to develop and maintain Product Information across existing and new Viatris products, ensuring compliance with regulatory requirements. The role supports Core Labelling (including CCDS and patient information) and collaborates on Global Ad Promo, Medical/Commercial material reviews, and regulatory strategy across