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The global CRO where clinical trials run on time.
Regulatory Officer
Location
Brazil
Posted
58 days ago
Salary
0
Seniority
Senior
Job Description
Regulatory Officer
PSI CRO AG
• 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
Job Requirements
- 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
- Excellent and flexible working conditions
- Extensive training and friendly, collegial team
- Competitive salary and benefits package
- Opportunities for personal and professional growth
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