Romania Job Openings
PSI CRO
Regulatory Officer
Bucharest
FULL TIME
November 15, 2024
PSI is a leading Contract Research Organization with more than 29 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
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.
Hybrid working arrangement in Bucharest, Romania
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
Qualifications
- College/University degree in Pharmacy, Medicine, Life Sciences, or an equivalent combination of education, training and experience
- Prior experience with clinical trial submissions, including submission in EU Clinical Trial Information System as per EU CT Regulation
- Full working proficiency in English; French, Spanish and/or Portuguese are 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
Additional Information
We offer:
- Excellent and flexible working conditions
- Extensive training and friendly team
- Competitive salary and benefits package
- Opportunities for personal and professional growth
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