15 Sep
|
AMGEN
|
Hyderabad
Career Category
Regulatory
Job Description
The Regulatory Labeling Manager, part of Global Labeling Compliance (GLC) is responsible for the planning, coordination, and execution of US regional labeling activities across the product lifecycle. The role serves as a key operational interface between Regulatory, Labeling Strategy, Artwork, Operations, Supply Chain, Publishing, external vendors, and other cross-functional stakeholders to enable timely and compliant delivery of US labeling.
The US LPM manages labeling activities from submission readiness through Health Authority (HA) negotiations, approval, artwork development, implementation, and post-approval activities. The role requires robust regulatory labeling knowledge, project leadership, independent decision-making, and the ability to manage multiple complex products and priorities simultaneously.
Key Responsibilities
- Lead and coordinate US labeling process management activities across assigned products, ensuring labeling deliverables are planned, developed, reviewed, approved,
and implemented in accordance with established processes and regulatory timelines.
- Serve as the point of contact for assigned products, working cross-functionally with Regulatory Leads/Strategists, Labeling Strategy, Artwork, Operations, Supply Chain, Publishing, Regulatory Promotions, vendors, and other relevant stakeholders.
- Manage US labeling activities supporting initial submissions, supplemental submissions, Health Authority negotiations, approvals, and post-approval implementation.
- Support labeling activities during FDA/Health Authority negotiations, coordinating labeling changes and associated artwork activities resulting from HA feedback and ensuring alignment across impacted stakeholders.
- Coordinate the creation, review, approval, and lifecycle management of US labeling artwork projects, ensuring appropriate source text, regulatory requirements, timelines, and stakeholder inputs are incorporated.
- Coordinate Structur
📌 Regulatory Labeling Manager (Hyderabad)
🏢 AMGEN
📍 Hyderabad