Fsp - Sr. Regulatory And Start Up Specialist

IQVIA Inc

Argentina
Fully remote
Site activation activities
Local regulatory submissions
Icf customization
The Sr. Regulatory & Start Up Specialist serves as the Single Point of Contact for investigative sites during study activation

Job Summary

  • The Sr. Regulatory & Start Up Specialist serves as the Single Point of Contact for investigative sites during study activation.
  • This role requires preparing and reviewing site regulatory documents while ensuring adherence to local regulations and SOPs.
  • Candidates must possess specific experience with ANMAT submissions and ethics committee presentations in Argentina.

Matching Summary

The Sr. Regulatory & Start Up Specialist serves as the Single Point of Contact for investigative sites during study activation.

Skills & Requirements

Must-have

  • Site Activation activities
  • Local regulatory submissions
  • ICF customization
  • Ethics committee presentations
  • ANMAT knowledge

Nice-to-have

  • Independent work capability
  • Project timeline planning
  • Sponsor contact experience

Key Requirements

  • Bachelor's Degree in life sciences
  • +3 years clinical research experience in Argentina
  • Fluent English communication skills
  • Experience with Local submissions and ICF customization

Work Rights

Not specified

Tailored Resume

Cover Letter