Regulatory Consultant (Italy)

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.

Job Description

You will focus on facilitating the start of research projects of novel medicinal products, while working closely with a team of clinical research experts.

Your role:

  • 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

Qualifications

  • 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
  • Detail-oriented
  • Ability to learn, plan and work in a dynamic team environment
  • Communication, collaboration, teamworking and problem-solving skills

Additional Information

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.

Expected salary:

Location: Milano

Job date: Sat, 12 Jun 2021 22:44:19 GMT

Apply for the job now!

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