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Regulatory Labeling Manager at Amgen

Setup
On-site
Location
Hyderabad, Telangana
Type
Full-time
Level
senior
Posted

Description

The Regulatory Labeling Manager leads US regional labeling process management across the product lifecycle, coordinating Regulatory, Labeling Strategy, Artwork, Operations, Supply Chain, Publishing, vendors, and other stakeholders. The role manages initial and supplemental submissions, Health Authority negotiations and approvals, labeling artwork, Structured Product Labeling, post-approval implementation, compliance, process improvements, and cross-functional risk escalation. It requires a bachelor’s or master’s degree and 9 to 12 years of directly related experience in regulatory affairs, labeling operations, or a related pharmaceutical or biotechnology function.

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