US Regulatory Lead
Core
US Regulatory Lead responsible for planning and executing regulatory strategies, submissions, and lifecycle management for Amgen products in the US.
Role type
Manager, US Regulatory Affairs
Builds
Regulatory strategies, submissions, and lifecycle management for medium-complexity biopharmaceutical products
Domain
Biotechnology / Pharmaceuticals / US Regulatory Affairs
Required skills
US regulatory strategy, regulatory submissions, agency interactions, label management, compliance monitoring, cross-functional collaboration, team leadership, regulatory research
Preferred skills
Drug development knowledge, FDA interaction experience, US legislation knowledge, project management, scientific communication, negotiation
Technologies
Regulatory submission systems, label management tools
Responsibilities
Align local regulatory requirements with corporate standards, plan and manage local regulatory submissions, act as point of contact with regulatory agencies, support global regulatory strategy, monitor changes in legislation, manage urgent safety communications, mentor junior regulatory representatives
Seniority
Manager, hands-on leadership