Regulatory Officer
PSI CRO
About The Position
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.
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
Nice To Haves
- Spanish is a plus
Responsibilities
- 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
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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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
