Regulatory Labeling Manager
Amgen · Hyderabad, India
RegulatoryFull-timeCompany career page
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Role summary
Amgen seeks a Regulatory Labeling Manager to oversee US labeling compliance and delivery across the product lifecycle. The role coordinates labeling activities from submission through Health Authority negotiations, approval, and post-approval implementation, working across regulatory, operations, and external teams.
What they're looking for
- Bachelor's or Master's degree with 9-12 years regulatory affairs or labeling experience
- US FDA pharmaceutical or biologic labeling and regulatory processes knowledge
- Experience supporting Health Authority submissions and post-approval implementation
- Proficiency managing multiple products and competing priorities simultaneously
- Experience with labeling artwork development, SPL, and RIM systems
- Strong independent decision-making and risk identification abilities
What you'll be doing
- Lead US labeling process management activities across assigned products ensuring regulatory compliance
- Serve as primary contact coordinating labeling efforts with regulatory, operations, and cross-functional teams
- Manage labeling activities for initial and supplemental submissions, HA negotiations, and approvals
- Support FDA and Health Authority negotiations by coordinating labeling changes and artwork updates
- Coordinate SPL initiation, review, quality control, and submission handoff to regulatory stakeholders
Privacy & handoff
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