Director Core Labeling Strategy

Mylan Inc.

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here’s how the Director Core Labeling Strategy role will make an impact:

Provide regulatory labelling leadership, governance, and expertise to Viatris products such that the Product Information texts (labelling) of existing and new products are successfully developed, maintained and implemented globally in compliance with applicable regulatory requirements.

In this role the individual will have responsibility for the creation, development, and maintenance of compliant Core Labelling documents including Company Core Data Sheets (CCDS) and associated patient information, as well as oversight of Global Ad Promo and Medical Marketing review and approval, in alignment with Viatris principles and procedures.

The role also contributes to strategic labelling development across the product lifecycle, including supporting early development programmes through the development of Target Product Labelling (TPL), competitive labelling analyses and regulatory precedent assessments to support global regulatory strategy and major submissions, including US Prescribing Information (USPI).

• Accountable for management of the global labelling process and labelling development across the assigned portfolio.
• Leads preparation, review and approval of global labelling documentation (e.g. CCDS, Core Patient Information) as well as territorial labelling documentation (e.g. Common EU SmPC’s and US Prescribing Information (USPI)) based on clinical and non-clinical dossier to support regulatory filings for submission to international regulatory agencies.
• Drives labelling strategy in partnership with Global Regulatory in line with the overall regulatory strategy by providing labelling expertise (labelling regulations, internal processes, competitive labelling analysis and impact assessment of competitor profiles) for CCDS, USPI (including Abbreviated New Drugs Applications, New Drug Applications and Biologics License Applications) and group managed EU SmPC’s (Centralized / Mutual Recognition / Decentralized Procedures) as well as abbreviated PIs thereof.
• Leads development and maintenance of Target Product Labelling (TPL) to guide clinical development strategy, regulatory positioning and cross-functional alignment, particularly for innovative or development-stage assets.
• Ensures close partnership of labelling leads with project leads and the regulatory matrix to ensure effective, strategic, and proactive labelling development. Interfaces directly with senior management and functional experts on business strategy and labelling content.
• Works closely with the aligned Regulatory Strategist and any other stakeholder teams as needed to lead all labelling aspects for the defined portfolio across both development and lifecycle management activities.
• Leads labelling updates and development, critically evaluating the data and principles upon which labelling statements are based to ensure clinical relevance and regulatory acceptance across the portfolio.
• Controls global Labelling compliance by reconciling labeling…