US Regulatory Lead
Core
Lead US Regulatory Affairs for the development, registration, and lifecycle management of Amgen molecules, ensuring compliance with US legislation and agency requirements.
Role type
Manager, US Regulatory Lead
Builds
Regulatory strategies, submissions, and lifecycle management for medium-complexity biopharmaceutical products
Domain
Biotechnology / Pharmaceuticals / US Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
US regulatory strategy, regulatory submissions, agency interaction, label management, compliance management, cross-functional collaboration, team leadership, regulatory research
Preferred skills
Drug development knowledge, FDA interaction experience, US legislation expertise, project management, stakeholder influence
Technologies
None stated
Responsibilities
Plan and execute regulatory strategies for assigned products; manage local regulatory submissions; act as point of contact with regulatory agencies; ensure label compliance; advise global teams on local implications; mentor junior regulatory representatives
Seniority
Manager, hands-on leadership