Manager, Regulatory Affairs -Labeling Nalanda Corporate Services

5.0 - 9.0 years

4 - 9 Lacs

Hyderabad

Work from Office

Experienced in pharmaceutical RA labeling, cGMP/FDA/CFR compliance, SPL creation, proofreading, and DSCSA. Skilled in MS Office, Adobe, TrackWise, SharePoint, and graphic design. Knowledge of label lifecycle, drug listing, and patent carve-outs.

Posted 5 months 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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