Regulatory Officer

PSI CRO AG

Regulatory Officer handling regulatory and ethics submissions of clinical studies in Brazil. Prepare trial documents, communicate with authorities, and manage safety reporting for clinical trials.

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