Senior Manager, Core Labelling Strategy - Global Labelling & Artwork COE

Company Overview

Viatris is focused on helping people around the world access better healthcare at every stage of life. The company aims to be a dependable partner in a changing healthcare environment through three priorities: making trusted medicines accessible across geographies and circumstances, advancing sustainable operations and innovative solutions to improve patient health, and using collective expertise to connect people with products and services.

Role Purpose

This position is responsible for providing strong regulatory labelling expertise, governance, and leadership to support the global maintenance of Core Labelling Strategy and product information for both established and new products. The role owns the creation, development, and ongoing upkeep of compliant core labelling documents, including review and approval of Global Ad Promo and Medical Marketing content, while working within Viatris principles and internal procedures.

The role must also be performed in line with all relevant SOPs, federal and state laws, OSHA requirements, health authority regulations, and departmental processes.

Key Responsibilities

• Own the labelling process and drive end-to-end labelling development.
• Lead the drafting, review, and approval of global labelling materials such as CCDS and Core Patient Information, along with territory-specific documents including Common EU SmPCs and USPIs, using clinical and non-clinical dossier data to support international regulatory submissions.
• Shape labelling strategy with Global Regulatory teams in alignment with wider regulatory plans, contributing specialist knowledge on labelling regulations, internal procedures, and competitor label assessments for CCDS, USPI, and group-managed EU SmPCs across Centralized, Mutual Recognition, and Decentralized pathways, including abbreviated PI versions.
• Build effective working partnerships with labelling leads, project leads, and the regulatory matrix to ensure labelling is proactive, strategic, and delivered efficiently.
• Work directly with senior leaders and functional subject-matter experts on business strategy and labelling content.
• Partner with the aligned Regulatory Strategist and other relevant teams to drive all labelling work for the assigned portfolio.
• Oversee labelling revisions and new development, carefully assessing the evidence and principles behind proposed statements to ensure they are clinically sound and acceptable to regulators.
• Coordinate with Global Product Safety and Risk Management / Safety Surveillance teams to confirm PI text is reviewed and aligned; escalate unresolved issues to the Global Labelling Committee for endorsement where needed.
• Bring commercial awareness and a strong understanding of competitor labels, emerging labelling practices, and agency expectations.
• Handle difficult regulatory and scientific issues, balance multiple priorities at once, and apply sound judgement in complex decision-making.
• Help influence internal thinking on proposed guidelines and regulations to support the external environment.
• Represent the organization in industry forums and external events when required, including groups such as DIA, Navitas, trade associations, and EMA- or FDA-led workshops and advisory committee activities.

Additional Information

Compensation is stated as INR 37,50,000 to INR 40,00,000 per annum.

Location: Hyderabad, India.