Amgen UK is seeking a Manager for its Labeling team to provide expert knowledge and support for regulatory compliance in labeling processes. The role involves collaboration with internal and external stakeholders, project management, and mentoring junior team members to ensure timely product launches
Job Summary
The LPM Manager supports the Global Labeling Process Management team to ensure timely Amgen product launches and provide expert labeling knowledge.
This role requires applying expert labeling knowledge to collaborate with local affiliates and regional regulatory affairs colleagues to plan and implement label changes.
The successful candidate will serve as the point of contact for assigned local markets and contribute to cross-functional teams for submissions to health authorities.
Matching Summary
Match Score: 85
Amgen UK is seeking a Manager for its Labeling team to provide expert knowledge and support for regulatory compliance in labeling processes. The role involves collaboration with internal and external stakeholders, project management, and mentoring junior team members to ensure timely product launches.
Skills & Requirements
Must-have
8 years labeling experience
Global labeling compliance expertise
Regional regulatory labeling knowledge
Artwork source text management
Change control regulatory assessments
Project management for translations
Nice-to-have
Mentoring junior team members
Continuous improvement practices
External industry committee visibility
Tolerance for ambiguity
Strong negotiation skills
Key Requirements
Bachelor's or Master's degree
Minimum 8 years of labeling experience
Experience in End-to-End Labeling Initiatives
Knowledge of HA Regulations and International Markets