This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Regulatory Affairs Associate – Labeling Strategy based in India.

Contribute to the development and lifecycle management of pharmaceutical labeling strategies that support regulatory compliance and improve patient access to innovative treatments. In this role, you will oversee global labeling documentation and coordinate regulatory activities across major international markets. You will collaborate with regulatory, quality, commercial, and other cross-functional teams to ensure accurate, timely, and compliant product information. From post-approval changes to packaging artwork and regulatory submissions, your expertise will help maintain product consistency throughout the lifecycle. You will work in a globally connected, remote environment that values precision, collaboration, and continuous career development.



This is an opportunity to strengthen your regulatory expertise while helping advance therapies that make a meaningful difference to patients worldwide.

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Accountabilities:

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Global Labeling Strategy and Documentation: Develop, maintain, and update global labeling documents, including Company Core Data Sheets (CCDS), United States Prescribing Information (USPI), and regional labels, ensuring alignment with requirements in the United States, European Union, Switzerland, Canada, Australia, and other markets.

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Regulatory Compliance and Lifecycle Management: Manage post-approval labeling activities, including artwork updates, safety variations, xEVMPD submissions, and Periodic Safety Update Reports (PSURs), in accordance with applicable regulations and recommendations from PRAC and CMDh.

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Regulatory Impact Assessments: Evaluate change-control requests affecting medicinal products in registered markets and assess their implications for labeling and regulatory compliance.

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Artwork Coordination and Approval: Coordi

📌 Senior Regulatory Affairs Associate- Labeling Strategy (India)
🏢 Jobgether
📍 India