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Amgen
Clinical Trials Regulatory Submission Associate
Remote · Argentina · Full time · Mid level
About the role
Support clinical trial regulatory submissions and related activities in Argentina ensuring compliance with local regulations and Amgen policies. Manage documentation, submissions, tracking, and administrative processes throughout the clinical trial lifecycle.
What you’ll do
• Provide administrative support to Local Regulatory Affairs team. • Prepare and submit clinical trial regulatory documentation. • Maintain regulatory tracking tools and study milestones. • Coordinate clinical trial submission and study start-up activities. • Support routine administrative processes related to regulatory activities.
What you’ll bring
• Master’s degree or Bachelor’s with 3 years clinical trials experience. • At least 1 year regulatory affairs or clinical trial start-up experience. • Knowledge of Argentine clinical trial regulations. • Strong communication skills in English. • Excellent organizational and time-management skills.
Life at Amgen
Amgen offers competitive benefits and a collaborative, inclusive culture supporting professional and personal growth.
About Amgen
Amgen is a biotech company pioneering treatments for serious illnesses with a broad portfolio addressing heart disease, cancer, and rare diseases.