The Local Regulatory Representative is responsible for aligning local regulatory requirements with Amgen's corporate standards while managing medium complexity product strategies
Job Summary
The Local Regulatory Representative is responsible for aligning local regulatory requirements with Amgen's corporate standards while managing medium complexity product strategies.
This role serves as the primary point of contact with regulatory agencies and oversees external vendor relationships to ensure timely and compliant filings.
The position requires developing and executing regulatory strategies for clinical trials, new drug applications, and lifecycle maintenance activities in compliance with national legislation.
Matching Summary
The Local Regulatory Representative is responsible for aligning local regulatory requirements with Amgen's corporate standards while managing medium complexity product strategies.
Skills & Requirements
Must-have
Local regulatory submissions management
Clinical trial application execution
Health authority interaction experience
Labeling development and maintenance
CRO oversight and coordination
Nice-to-have
Strong cross-functional collaboration skills
Negotiation and influencing abilities
Cultural awareness across borders
Conflict resolution capabilities
Key Requirements
Doctorate or Master's degree in scientific area
3 to 5 years directly related regulatory experience