Regulatory Consultant (Italy)
Job title: Regulatory Consultant (Italy)
Company: PSI CRO
Job description: Company Description
PSI is a leading Contract Research Organization with more than 25 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.
You will focus on facilitating the start of research projects of novel medicinal products, while working closely with a team of clinical research experts.
- Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities
- 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
- Assist with feasibility research and business development requests
- College/University degree or an equivalent combination of education, training and experience
- Ability to independently manage clinical trial submission in Italy
- Full working proficiency in English and Italian
- Proficiency in MS Office applications
- Ability to learn, plan and work in a dynamic team environment
- Communication, collaboration, teamworking and problem-solving skills
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.
Job date: Sat, 12 Jun 2021 22:44:19 GMT
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