Clinical Trials Regulatory Submission Senior Associate

• Performing Regulatory submissions in Argentina to ANMAT/ CCIS
• Compiling submission dossier
• Execution of all regulatory activities for clinical trial projects and programs, according to local regulations and Amgen’s policy
• Interacting directly with Functional Service Providers for Ethics Committee Services, Clinical Project Management (Local Trial Managers), Global Study Operations, International Regulatory Team, CMC Global Product Leads, Pharmacovigilance, Clinical Supply Chain and vendors acting as Importer of Record
• Performing efficiently end-to-end Clinical Trials Regulatory submissions in country for new and ongoing project(s) or programs
• Submitting, with the input of importer of record, study specific import licenses extensions until approvals
• Communicating overall regulatory status to internal teams and service providers
• Attending to project meetings with cross functional department leads to provide regulatory timelines and requirements for regulatory submissions and approvals
• Collaborating with internal team members to establish timelines and clarify regulatory requirements
• Maintaining clinical trial regulatory requirements' database, including regular updates to checklists
• Maintaining local public registry in Argentina (ReNIS database) with input of Local Trial Managers
• Facilitating communication with the regional or local study team during the total duration of study, closely monitoring to ensure regulatory milestones are met
• Escalating issues to leadership, including plans for addressing/mitigating risks/gaps

• Master’s degree
• OR Bachelor’s degree and 5 years of Clinical Trials experience
• Minimum 3 years of regulatory submissions and/or study start-up experience is required with 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 is a strong plus
• Ability to plan, develop, and manage timelines, including keeping them up to date
• Comfortable managing multiple projects and priorities at the same time
• Skilled at building and maintaining positive relationships with health authorities, colleagues, managers, and service providers
• Able to work independently and asynchronously across time zones in a collaborative, matrixed team environment

Experience and/or technical knowledge in Import License extensions

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards