The Local Senior Associate Regulatory Affairs provides high-level regulatory leadership for Amgen-sponsored clinical studies in Mexico
Job Summary
The Local Senior Associate Regulatory Affairs provides high-level regulatory leadership for Amgen-sponsored clinical studies in Mexico.
Independently handle and maintain complete, accurate, and traceable regulatory documentation supporting clinical protocol approvals for initial and lifecycle management protocols submitted via DIGIPRiS.
Apply regulatory and ethical requirements, including CONBIOÉTICA guidelines, to support compliance with local Ethics Committee expectations for protocol, Inform Consent Form and other subject material or information.
Matching Summary
The Local Senior Associate Regulatory Affairs provides high-level regulatory leadership for Amgen-sponsored clinical studies in Mexico.
Skills & Requirements
Must-have
Clinical trial authorizations
Local regulatory strategy
Health Authority collaboration
Ethics Committee collaboration
Good Clinical Practice (GCP) compliance
Regulatory risk assessment and mitigation
Unified Formats submission
Nice-to-have
Collaborative and science-based culture
Passion for challenges
Transforming patient lives
Award-winning culture
Key Requirements
Master’s degree and experience in Clinical Regulatory Affairs in Mexico
Bachelor’s degree and 2 years of experience in Clinical Regulatory Affairs in Mexico
Associate’s degree and 6 years of experience in Clinical Regulatory Affairs in Mexico