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Regulatory Officer
PSI CRO AG. Prepare clinical trial documents for Regulatory and Ethics submissions .
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
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial submissionsregulatory activitiessafety reportingfeasibility researchdocument reviewregulatory training
Soft Skills
detail-orientedcommunication skillscollaboration skillsproblem-solving skillsability to learnplanning skillsteamwork