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PSI CRO AG

Regulatory Officer

PSI CRO AG

. Prepare clinical trial documents for Regulatory and Ethics submissions .

Posted 4/21/2026full-timeRemote • 🇧🇷 BrazilMid-LevelSeniorWebsite

About the role

Key responsibilities & impact
  • Prepare clinical trial documents for Regulatory and Ethics submissions
  • Communicate with regulatory authorities and support communication with ethics committees, project teams and vendors on regulatory-related matters
  • Review translations of essential documents subject to clinical trial submission
  • Track the regulatory project documentation flow
  • Review documents to greenlight IP release to sites
  • Manage safety reporting to authorities
  • Deliver regulatory training to project teams
  • Assist with feasibility research and business development requests

Requirements

What you’ll need
  • College/University degree or an equivalent combination of education, training and experience
  • Prior experience with clinical trial submissions to ANVISA in Brazil
  • Prior experience with regulatory activities for clinical trials
  • Full working proficiency in English and Portuguese, Spanish is a plus
  • Proficiency in MS Office applications
  • Detail-oriented
  • Ability to learn, plan and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills

Benefits

Comp & perks
  • Excellent and flexible working conditions
  • Extensive training and friendly, collegial team
  • Competitive salary and benefits package
  • Opportunities for personal and professional growth

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
clinical trial submissionsregulatory activitiessafety reportingfeasibility researchdocument reviewregulatory training
Soft Skills
detail-orientedcommunication skillscollaboration skillsproblem-solving skillsability to learnplanning skillsteamwork