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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory affairs and clinical trial processes, with a strong focus on compliance with Argentine regulations and effective communication with stakeholders. Proficient in managing regulatory submissions, documentation, and administrative support within clinical trial environments.
Highest-signal resume keywords
Regulatory Affairs ExperienceClinical Trial Submission ManagementKnowledge of ANMAT and CCIS RegulationsStrong Written and Verbal Communication SkillsOrganizational and Time-Management Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trials ExperienceRegulatory Documentation PreparationRegulatory Tracking ToolsClinical Trial RegistrationSubmission Logs ManagementRegulatory ComplianceGCP KnowledgeAttention to DetailQuality AssuranceData Management
Soft Skills
Interpersonal SkillsCollaboration SkillsInitiativeAccountabilitySound Judgment
Tools & Technologies
Amgen SystemsDigital ToolsAI ToolsVendor Documentation ManagementInvoice Tracking
Industry Keywords
Clinical Trial RegulationsRegulatory SubmissionsStudy Start-Up ActivitiesStakeholder InteractionCross-Functional Teamwork
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Support the execution of clinical trial regulatory submissions and related regulatory activities in Argentina
- Prepare, review, and submit clinical trial regulatory documentation to ANMAT, CCIS, and other applicable authorities
- Provide administrative and operational support to the Local Regulatory Affairs team
- Maintain regulatory tracking tools, submission logs, databases, and study milestones
- Perform clinical trial registration and maintain study information in RENIS
- Maintain, archive, and file regulatory submissions, approvals, correspondence, and essential study documents in Amgen systems
- Coordinate clinical trial submission and study start-up activities
- Support administrative processes including purchase orders, vendor documentation, invoice tracking, and payment follow-up
- Use Amgen-approved digital and AI tools for administrative and regulatory activities
- Identify opportunities to simplify or automate recurring administrative processes
- Participate in regulatory and study-related meetings and execute assigned activities in compliance with regulations, GCP, and Amgen SOPs
- Escalate issues, risks, or gaps to leadership and support mitigation plans
Requirements
What you’ll need- Master’s degree OR Bachelor’s degree and 3 years of Clinical Trials experience
- At least 1 year of experience in regulatory affairs and/or clinical trial start-up activities
- Knowledge of Argentine clinical trial regulations (ANMAT and CCIS)
- Strong written and verbal communication skills in English
- Ability to effectively interact with internal and external stakeholders
- Excellent organizational and time-management skills
- Ability to manage multiple priorities, track activities, meet deadlines, and maintain accurate records
- Strong interpersonal and collaboration skills
- Ability to build effective working relationships across cross-functional, matrixed, and geographically dispersed teams
- Ability to work independently while demonstrating initiative, accountability, and sound judgment
- High attention to detail and commitment to accuracy, quality, and compliance in regulatory documentation and processes
Benefits
Comp & perks- Competitive and comprehensive Total Rewards Plans aligned with local industry standards
- Professional and personal growth and well-being support
- Competitive benefits
- Collaborative culture
- Reasonable accommodations for applicants and employees with disabilities, consistent with legal requirements