Perform Regulatory submissions in Argentina to ANMAT/ CCIS, compiling submission dossier, and execution of all regulatory activities for clinical trial projects and programs
Job Summary
Perform Regulatory submissions in Argentina to ANMAT/ CCIS, compiling submission dossier, and execution of 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 fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
Matching Summary
Perform Regulatory submissions in Argentina to ANMAT/ CCIS, compiling submission dossier, and execution of all regulatory activities for clinical trial projects and programs.
Skills & Requirements
Must-have
Regulatory submissions in Argentina
Compile submission dossier
Clinical trial project execution
Local regulations and Amgen policy
Interact with cross-functional teams
Maintain regulatory database
Nice-to-have
Collaborative, innovative, science-based culture
Passion for challenges
Positive relationships with health authorities
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)
Excellent written and verbal communication skills in English
Experience and/or technical knowledge in Import License extensions
Ability to plan, develop, and manage timelines
Comfortable managing multiple projects and priorities
Able to work independently and asynchronously across time zones