4.0 - 8.0 years

0 Lacs

delhi

On-site

Role Overview: As a Regulatory Global Labeling Operations Specialist, you will play a crucial role in authoring and updating labeling documents, ensuring compliance with Health Authority regulations, and maintaining submission quality. Key Responsibilities: - Oversee EU labels, including EU linguistic quality control (QC) coordination and support. - Coordinate labeling workflow activities and provide support for labeling change controls. - Manage artwork, including designing, reviewing, and updating packaging components. - Responsible for generating and maintaining the Structured Product Labeling (SPL) for all products. - Collaborate with regulatory and product teams to ensure accurate produ...

Posted 3 weeks ago

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Global Labelling Lead Indegene

6 - 11 years

17 - 19 Lacs

Hyderabad, Pune, Bengaluru

Hybrid

Role & responsibilities 8-10 years of core global labeling experience Knowledge of U.S. and EU regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels. Demonstrates knowledge and understanding of company Core Data Sheets (CDS) and the dynamics of Labelling Team purpose and objectives. Demonstrates ability to understand how updating one section of a label may impact another and to propose recommendations to the Labelling Team. Clear and effective written and verbal communication skills. Ability to liaise with stakeholders using effective means of communication Demonstrates ability to inf...

Posted 5 months ago

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