Perform Regulatory submissions in Argentina to ANMAT/ CCIS, compiling submission dossier, and executing all regulatory activities for clinical trial projects and programs
Job Summary
Perform Regulatory submissions in Argentina to ANMAT/ CCIS, compiling submission dossier, and executing all regulatory activities for clinical trial projects and programs.
Communicate overall regulatory status to internal teams and service providers, and attend project meetings to provide regulatory timelines and requirements.
Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Matching Summary
Perform Regulatory submissions in Argentina to ANMAT/ CCIS, compiling submission dossier, and executing all regulatory activities for clinical trial projects and programs.
Skills & Requirements
Must-have
perform regulatory submissions in Argentina
compile submission dossiers
execute regulatory activities for clinical trials
manage import license extensions
Nice-to-have
collaborative, innovative, and science based culture
passion for challenges
transforming lives of patients
Key Requirements
Master’s degree OR Bachelor’s degree and 5 years of Clinical Trials experience
Minimum 3 years regulatory submissions/study start-up experience
Strong technical knowledge performing Clinical Trial Applications in Argentina (ANMAT, CCIS)
Experience and/or technical knowledge in Import License extensions