Live opening · Posted 1 day ago
Regulatory Officer
PSI CRO · Belgrade, , Serbia
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At a glance
The key details from the original listing.
CompanyPSI CRO
LocationBelgrade, , Serbia
Job typeFull-time
Work modeNo
Source
Smartrecruiters
Listed1 day ago
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About the role
Description supplied by the original job listing.
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.
Office-based position
Your role:
Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications
Communicate with regulatory authorities, 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
College/University degree or an equivalent combination of education, training and experience
Prior experience with clinical trial submissions is required
Full working proficiency in English and Serbian
Proficiency in MS Office applications
Detail-oriented
Ability to learn, plan and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
Employment type
Full-time
Work arrangement
No
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