Clinical Trials Regulatory Submission Sr. Associate

Amgen

Argentina
Not specified; not specified; competitive total re...
Master's or bachelor's degree required
5 years clinical trials experience
3 years regulatory submissions experience
This role is responsible for performing regulatory submissions in Argentina to ANMAT/CCIS and compiling submission dossiers for clinical trial projects

Job Summary

  • This role is responsible for performing regulatory submissions in Argentina to ANMAT/CCIS and compiling submission dossiers for clinical trial projects.
  • The position requires interacting directly with functional service providers, global study operations, and local trial managers to ensure regulatory milestones are met.
  • Amgen offers a collaborative culture and competitive total rewards plans aligned with local industry standards to support professional growth.

Matching Summary

This role is responsible for performing regulatory submissions in Argentina to ANMAT/CCIS and compiling submission dossiers for clinical trial projects.

Salary

Not specified; Not specified; Competitive Total Rewards Plans aligned with local industry standards

Skills & Requirements

Must-have

  • Master's or Bachelor's degree required
  • 5 years Clinical Trials experience
  • 3 years regulatory submissions experience
  • Strong technical knowledge of ANMAT and CCIS
  • Excellent English communication skills

Nice-to-have

  • Experience with Import License extensions
  • Ability to manage multiple projects simultaneously
  • Comfortable working asynchronously across time zones
  • Skilled at building relationships with health authorities

Key Requirements

  • Master's degree OR Bachelor's degree with 5 years experience
  • Minimum 3 years regulatory submissions experience
  • Technical knowledge of Argentina clinical trial applications
  • English language proficiency

Work Rights

Not specified

Tailored Resume

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