Clinical Trials Regulatory Submission Associate

About the role

Amgen is hiring a Clinical Trials Regulatory Submission Associate in Argentina to support the execution of clinical trial regulatory submissions and related regulatory activities. The role ensures compliance with local regulations, Good Clinical Practice (GCP) requirements and Amgen policies, preparing, reviewing, submitting and maintaining regulatory documentation throughout the clinical trial lifecycle under the guidance of the Local Regulatory Affairs team.

Key responsibilities

• Prepare, review and submit clinical trial regulatory documentation to ANMAT, CCIS and other applicable authorities
• Maintain regulatory tracking tools, submission logs, databases and study milestones, and share status updates with stakeholders
• Perform clinical trial registration in the Argentine National Registry of Health Research (RENIS)
• Maintain, archive and file submissions, approvals, correspondence and study documents in Amgen systems with version control
• Coordinate submission and study start-up activities, including document collection, follow-up and meeting scheduling
• Support routine administrative processes such as purchase orders, vendor documentation, invoice tracking and payment follow-up
• Use Amgen-approved digital and AI tools for document review, summary drafting and tracker maintenance
• Identify ways to simplify or automate recurring administrative tasks and take part in regulatory and study meetings
• Escalate issues, risks or gaps to leadership and support mitigation plans

Required profile

• Master's degree, or Bachelor's degree plus 3 years of clinical trials experience
• Preferred: at least 1 year of regulatory affairs and/or clinical trial start-up experience, with knowledge of Argentine regulations (ANMAT and CCIS)
• Strong written and verbal English, with good organizational, time-management and collaboration skills
• Ability to work independently, with attention to detail and accuracy in regulatory documentation