Fsp - Regulatory And Start Up Specialist

IQVIA

Sao Paulo, SP, Brazil
Hybrid
Cep/conep submission experience
Anvisa regulatory knowledge
Icf local customization skills
The role serves as the primary point of contact for investigative sites, managing feasibility and start-up activities according to regulations and SOPs

Job Summary

  • The role serves as the primary point of contact for investigative sites, managing feasibility and start-up activities according to regulations and SOPs.
  • Candidates must possess advanced knowledge of Brazilian regulatory bodies including CEP/CONEP and ANVISA for initial submissions and amendments.
  • This hybrid position is based in Sao Paulo, SP, requiring close collaboration with Site Activation Managers and Project Management teams.

Matching Summary

The role serves as the primary point of contact for investigative sites, managing feasibility and start-up activities according to regulations and SOPs.

Skills & Requirements

Must-have

  • CEP/CONEP submission experience
  • ANVISA regulatory knowledge
  • ICF local customization skills
  • Site activation and maintenance
  • Contract negotiation with sites

Nice-to-have

  • Strong communication skills
  • Ability to work in a team
  • Advanced English proficiency
  • Experience with project timelines

Key Requirements

  • Bachelor's Degree in Life Sciences or related field
  • 1-2 years experience in CRO or pharma regulatory role
  • Specific experience with CEP/CONEP and ANVISA submissions

Work Rights

Not specified

Tailored Resume

Cover Letter