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Check out JobsAI Senior Manager - US Regulatory Affairs Lead-Oncology
Company: Amgen
Job Overview
The Senior Manager, US Regulatory Affairs Lead-Oncology plans and executes regulatory strategies for Amgen products. Key responsibilities include:
- Developing and implementing regional regulatory strategies
- Managing agency interactions
- Ensuring Amgen acquires and maintains required licenses for clinical trials and marketed products
- Ensuring regulatory compliance with a focus on patient safety
The role involves:
- Participating in various teams
- Leading the development of regional regulatory documents
- Providing regulatory direction
- Managing regional label submission strategy and timelines