6.0 - 11.0 years

6 - 11 Lacs

hyderabad, telangana, india

On-site

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 influence and negotiate whe...

Posted 1 month ago

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labeling specialist Biocon Biologics Limited

6.0 - 11.0 years

6 - 16 Lacs

bengaluru

Work from Office

Key Responsibilities: • Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products. • Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team. • Responsible for Promotional Material Review and participate in CFT meetings representing Regulatory on strategic decisions by ensuring no misleading information. • Responsible to Coordinate with External Vendor to ensure Translations documents are prepared / reviewed to support Global Regulatory Submissions. • Responsible for SPL Preparation for Initial Submission / Labelling Respons...

Posted 2 months ago

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