Regulatory Officer
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people then PSI is the right choice for you.
Remote Work :
No
Employment Type :
Full-time
Key Skills
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- IT Support
- Bank
- Asp.Net MVC
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more
