Amgen is seeking a Senior Associate in Regulatory Affairs for Clinical Studies in Mexico City. The role involves providing regulatory leadership for clinical studies, ensuring compliance with local regulations, and collaborating with various teams to support timely clinical trial authorizations
Job Summary
The Local Senior Associate Regulatory Affairs provides high-level regulatory leadership for Amgen-sponsored clinical studies in Mexico.
Key responsibilities include independently handling and maintaining regulatory documentation supporting clinical protocol approvals and lifecycle management.
Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Matching Summary
Match Score: 85
Amgen is seeking a Senior Associate in Regulatory Affairs for Clinical Studies in Mexico City. The role involves providing regulatory leadership for clinical studies, ensuring compliance with local regulations, and collaborating with various teams to support timely clinical trial authorizations.
Skills & Requirements
Must-have
clinical study authorizations
lifecycle management
regulatory documentation
health authority collaboration
GCP compliance
Nice-to-have
collaborative culture
science-based environment
patient-focused mission
Key Requirements
Master’s degree in health sciences or related field and experience in Clinical Regulatory Affairs in Mexico
Bachelor’s degree in health sciences or related field and 2 years of experience in Clinical Regulatory Affairs in Mexico
Associate’s degree in health sciences or related field and 6 years of experience in Clinical Regulatory Affairs in Mexico
Proficiency in English, both in oral and written communication